{
"description": "***Content TBD***\\n\\nThis IG is developed for the Data exchange industry – Pharmaceutical Quality (PQ) project \\n* [Project Proposal: PSS-2137](https://jira.hl7.org/browse/PSS-2137)\\n* [Project Scope Statement: PSS-2145](https://jira.hl7.org/browse/PSS-2145)",
"_filename": "ImplementationGuide-hl7.fhir.uv.pharm-quality.json",
"package_name": "hl7.fhir.uv.pharm-quality",
"definition": {
"page": {
"name": "index.html",
"page": [ {
"name": "use_cases.html",
"title": "Business Use Cases",
"generation": "markdown"
}, {
"name": "domains.html",
"page": [ {
"name": "identification.html",
"title": "Identification",
"generation": "markdown"
}, {
"name": "identification_rend_p1.html",
"title": "Identification: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "identification_rend_p2.html",
"title": "Identification: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "identification_rend_p3.html",
"title": "Identification: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "identification_rend_s1.html",
"title": "Identification: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "identification_rend_s2.html",
"title": "Identification: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "composition.html",
"title": "Composition",
"generation": "markdown"
}, {
"name": "composition_rend_p.html",
"title": "Composition: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "composition_rend_s.html",
"title": "Composition: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "impurities.html",
"title": "Impurities",
"generation": "markdown"
}, {
"name": "impurities_rend_p.html",
"page": [ {
"name": "impurities_rend_s.html",
"title": "Impurities: CMC synthetic data rendering - drug substance",
"generation": "markdown"
} ],
"title": "Impurities: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "organizations.html",
"title": "Organizations",
"generation": "markdown"
}, {
"name": "organizations_rend.html",
"title": "Organizations: CMC synthetic data rendering",
"generation": "markdown"
}, {
"name": "batch_info.html",
"title": "Batch/Lot Information",
"generation": "markdown"
}, {
"name": "batch_info_rend_p.html",
"title": "Batch/Lot Information: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "batch_info_rend_s.html",
"title": "Batch/Lot Information: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "batch_anal.html",
"title": "Batch Analysis",
"generation": "markdown"
}, {
"name": "batch_anal_rend_p.html",
"title": "Batch Analysis: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "batch_anal_rend_s.html",
"title": "Batch Analysis: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "batch_formula.html",
"title": "Batch Formula",
"generation": "markdown"
}, {
"name": "batch_formula_rend_p.html",
"title": "Batch Formula: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "mnf_process.html",
"title": "Manufacturing Process",
"generation": "markdown"
}, {
"name": "mnf_process_rend_p.html",
"title": "Manufacturing Process: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "mnf_process_rend_s.html",
"title": "Manufacturing Process: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "process_valid.html",
"title": "Process Validation",
"generation": "markdown"
}, {
"name": "process_valid_rend_p.html",
"title": "Process Validation: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "process_valid_rend_pb.html",
"title": "Process Validation: CMC synthetic data rendering - drug product, biologic",
"generation": "markdown"
}, {
"name": "process_valid_rend_s.html",
"title": "Process Validation: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "anal_proc.html",
"title": "Analytical Procedures",
"generation": "markdown"
}, {
"name": "anal_proc_rend_p.html",
"title": "Analytical Procedures: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "anal_proc_rend_s.html",
"title": "Analytical Procedures: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "container.html",
"title": "Container Closure System",
"generation": "markdown"
}, {
"name": "container_rend_p.html",
"title": "Container Closure System: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "container_rend_s.html",
"title": "Container Closure System: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "stability.html",
"title": "Stability Study",
"generation": "markdown"
}, {
"name": "stability_rend_p.html",
"title": "Stability Study: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "stability_rend_s.html",
"title": "Stability Study: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "drug_specification.html",
"title": "Drug Specification",
"generation": "markdown"
}, {
"name": "drug_specification_rend_p.html",
"title": "Drug Specification: CMC synthetic data rendering - drug product",
"generation": "markdown"
}, {
"name": "drug_specification_rend_s.html",
"title": "Drug Specification: CMC synthetic data rendering - drug substance",
"generation": "markdown"
}, {
"name": "compatibility.html",
"title": "Compatibility",
"generation": "markdown"
}, {
"name": "compatibility_rend_p.html",
"title": "Compatibility: CMC synthetic data rendering - drug product",
"generation": "markdown"
} ],
"title": "Domains Overview",
"generation": "markdown"
}, {
"name": "best_practices.html",
"title": "Best Practices, Resources",
"generation": "markdown"
}, {
"name": "downloads.html",
"title": "Downloads",
"generation": "markdown"
} ],
"title": "Home Page",
"generation": "markdown"
},
"grouping": [ {
"id": "b6-analytical",
"name": "Analytical Procedures",
"description": "FHIR artifacts that provide details about test methods used to analyze drug substances and drug products including compendial and non-compendial testing."
}, {
"id": "b9-batchanalyses",
"name": "Batch Analysis",
"description": "FHIR artifacts that provide details about drug substance and drug product batch release testing and results."
}, {
"id": "b7-batchformula",
"name": "Batch Formula",
"description": "FHIR artifacts that provide details about drug substance and drug product master batch properties and formula."
}, {
"id": "b8-batchinfo",
"name": "Batch or Lot Information",
"description": "FHIR artifacts that provide details about batch(es) of the drug substance and drug product with identifiers."
}, {
"id": "b14-compatibility",
"name": "Compatibility",
"description": "FHIR artifacts that provide details about compatibility studies and results."
}, {
"id": "b17-composition",
"name": "Composition",
"description": "FHIR artifacts that provide details about drug substance and drug product components, materials, and Quality reference standards."
}, {
"id": "b10-container",
"name": "Container Closure System",
"description": "FHIR artifacts that provide details about primary and secondary packaging components for drug substance and drug product."
}, {
"id": "b12-specification",
"name": "Drug Specification",
"description": "FHIR artifacts that provide details about drug substance or drug product release and stability specification (tests, acceptance criteria)."
}, {
"id": "b1-id",
"name": "Identification",
"description": "FHIR artifacts that provide details about the drug substance and drug product nomenclature; structure; physicochemical properties; and manufacture."
}, {
"id": "b15-impurities",
"name": "Impurities",
"description": "FHIR artifacts that provide details about impurity identification and characterization."
}, {
"id": "b5-mnf",
"name": "Manufacturing Process",
"description": "FHIR artifacts that provide a manufacturing process description and details about unit operations, process parameters, and in-process controls."
}, {
"id": "b4-organizations",
"name": "Organizations",
"description": "FHIR artifacts that provide details about each facility or legal entity involved in the manufacture of the medicinal product. This includes but is not limited to: name, identifier, and location address, for marketing authorization holders, sponsors, regulatory authorities, manufacturers, supplier, test site, packaging site."
}, {
"id": "b13-processvalidation",
"name": "Process Validation",
"description": "FHIR artifacts that provide details about manufacturing process validation protocols and results."
}, {
"id": "b11-stabilitystudy",
"name": "Stability Study",
"description": "FHIR artifacts that provide details about a stability study including stability study design (tests and acceptance criteria), drug substance or drug product batches involved, test results, and conclusion."
}, {
"id": "building-blocks-1",
"name": "Component Building Block Profiles",
"description": "FHIR artifacts used across many PQ domains."
}, {
"id": "building-blocks-2",
"name": "Component Building Block Examples"
}, {
"id": "extensions1",
"name": "Extensions"
}, {
"id": "examples1",
"name": "Additional ObservationDefinition Examples"
}, {
"id": "examples2",
"name": "Additional SpecimenDefinition Examples"
}, {
"id": "examples3",
"name": "Additional SubstanceDefinition Examples"
}, {
"id": "examples4",
"name": "Additional Observation Examples"
}, {
"id": "term",
"name": "Terminology: Example Code Systems",
"description": "Examples of code systems that may be defined and used within a local implementation, such as within one organization."
} ],
"resource": [ {
"name": "Profile: Bundle - Drug Product",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Drug Product",
"reference": "StructureDefinition/Bundle-drug-product-pq"
},
"groupingId": "b1-id",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.2 Drug Product."
}, {
"name": "Profile: Bundle - Product Microbiological Attributes",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Product Microbiological Attributes",
"reference": "StructureDefinition/Bundle-drug-product-microbiological-attributes-pq"
},
"groupingId": "b1-id",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.5 Microbiological Attributes."
}, {
"name": "Profile: Bundle - Product Excipients",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Product Excipients",
"reference": "StructureDefinition/Bundle-drug-product-excipients-pq"
},
"groupingId": "b1-id",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.4 Control of Excipients, subsections 3.2.P.4.5 Excipients of Human or Animal Origin and 3.2.P.4.6 Novel Excipients."
}, {
"name": "Profile: Bundle - Substance General Properties",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Substance General Properties",
"reference": "StructureDefinition/Bundle-drug-substance-general-properties-pq"
},
"groupingId": "b1-id",
"description": "This Bundle profile represents the structured data in CTD section 3.2.S.1 General Information, subsection 3.2.S.1.3 General Properties."
}, {
"name": "Profile: Bundle - Substance Characterization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Substance Characterization",
"reference": "StructureDefinition/Bundle-drug-substance-characterization-pq"
},
"groupingId": "b1-id",
"description": "This Bundle profile represents the structured data in CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.1 – Elucidation of Structure and Other Characteristics."
}, {
"name": "Example: Bundle – Drug Product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-product-pq-ex1"
},
"groupingId": "b1-id",
"description": "Example of Bundle – Drug Product."
}, {
"name": "Example: Bundle – Product Microbiological Attributes",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-microbiological-attributes-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-microbiological-attributes-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-product-microbiological-attributes-pq-ex1"
},
"groupingId": "b1-id",
"description": "Example of Bundle – Product Microbiological Attributes."
}, {
"name": "Example: Bundle – Product Excipients",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-excipients-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-excipients-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-product-excipients-pq-ex1"
},
"groupingId": "b1-id",
"description": "Example of Bundle – Product Excipients."
}, {
"name": "Example: Bundle – Substance General Properties",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-general-properties-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-characterization-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-substance-general-properties-pq-ex1"
},
"groupingId": "b1-id",
"description": "Example of Bundle – Substance General Properties."
}, {
"name": "Example: Bundle – Substance Characterization",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-characterization-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-characterization-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-substance-characterization-pq-ex1"
},
"groupingId": "b1-id",
"description": "Example of Bundle – Substance Characterization."
}, {
"name": "Profile: Bundle - Product Composition",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Product Composition",
"reference": "StructureDefinition/Bundle-drug-product-composition-pq"
},
"groupingId": "b17-composition",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.1 Description and Composition of the Drug Product."
}, {
"name": "Profile: Bundle - Reference Standards",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Reference Standards",
"reference": "StructureDefinition/Bundle-drug-reference-standards-pq"
},
"groupingId": "b17-composition",
"description": "This Bundle profile represents the structured data in CTD sections 3.2.P.6 Reference Standards or Materials and 3.2.S.5 Reference Standards or Materials."
}, {
"name": "Example: Bundle – Product Composition",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-composition-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-composition-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-product-composition-pq-ex1"
},
"groupingId": "b17-composition",
"description": "Example of Bundle – Product Composition."
}, {
"name": "Example: Bundle – Reference Standards, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-reference-standards-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-reference-standards-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-reference-standards-pq-ex2-sub"
},
"groupingId": "b17-composition",
"description": "Example of Bundle – Reference Standards for drug substance."
}, {
"name": "Profile: Bundle - Impurities",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle - Impurities",
"reference": "StructureDefinition/Bundle-product-impurities-pq"
},
"groupingId": "b15-impurities",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.5 Characterisation of Impurities and CTD section 3.2.S.3 Characterisation, subsection 3.2.S.3.2 Impurities."
}, {
"name": "Example: Bundle - Impurities, product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-product-impurities-pq-ex1"
},
"groupingId": "b15-impurities",
"description": "Example of Bundle - Impurities for drug product."
}, {
"name": "Example: Bundle - Impurities, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-impurities-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-product-impurities-pq-ex2-sub"
},
"groupingId": "b15-impurities",
"description": "Example of Bundle - Impurities for drug substance."
}, {
"name": "Profile: Bundle - Organizations",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle - Organizations",
"reference": "StructureDefinition/Bundle-organizations-pq"
},
"groupingId": "b4-organizations",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.1 Manufacturer(s) and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.1 Manufacturer(s)."
}, {
"name": "Example: Bundle - Organizations",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-organizations-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-organizations-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-organizations-pq-ex1"
},
"groupingId": "b4-organizations",
"description": "Example of Bundle - Organizations for either drug product or drug substance."
}, {
"name": "Profile: Bundle - Product Batch Information",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Product Batch Information",
"reference": "StructureDefinition/Bundle-drug-product-batch-info-pq"
},
"groupingId": "b8-batchinfo",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses."
}, {
"name": "Profile: Bundle - Substance Batch Information",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Substance Batch Information",
"reference": "StructureDefinition/Bundle-drug-substance-batch-info-pq"
},
"groupingId": "b8-batchinfo",
"description": "This Bundle profile represents the structured data in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses."
}, {
"name": "Example: Bundle – Product Batch Information",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-product-batch-info-pq-ex1"
},
"groupingId": "b8-batchinfo",
"description": "Example of Bundle – Product Batch Information."
}, {
"name": "Example: Bundle – Substance Batch Information",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-substance-batch-info-pq-ex1"
},
"groupingId": "b8-batchinfo",
"description": "Example of Bundle – Substance Batch Information."
}, {
"name": "Profile: Bundle - Batch Analysis",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Batch Analysis",
"reference": "StructureDefinition/Bundle-batch-analysis-pq"
},
"groupingId": "b9-batchanalyses",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses and CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 Batch Analyses."
}, {
"name": "Example: Bundle – Batch Analysis, product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-batch-analysis-pq-ex1-prod"
},
"groupingId": "b9-batchanalyses",
"description": "Example of Bundle – Batch Analysis for drug product."
}, {
"name": "Example: Bundle – Batch Analysis, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-analysis-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-batch-analysis-pq-ex2-sub"
},
"groupingId": "b9-batchanalyses",
"description": "Example of Bundle – Batch Analysis for drug substance."
}, {
"name": "Profile: Bundle - Batch Formula",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Batch Formula",
"reference": "StructureDefinition/Bundle-batch-formula-pq"
},
"groupingId": "b7-batchformula",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.2 Batch Formula."
}, {
"name": "Example: Bundle - Batch Formula",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-formula-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-batch-formula-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-batch-formula-pq-ex1"
},
"groupingId": "b7-batchformula",
"description": "Example of Bundle - Batch Formula for drug product."
}, {
"name": "Profile: Bundle - Manufacturing",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle - Manufacturing",
"reference": "StructureDefinition/Bundle-product-manufacturing-pq"
},
"groupingId": "b5-mnf",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.3 Description of Manufacturing Process and Process Controls and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.2 Description of Manufacturing Process and Process Controls."
}, {
"name": "Example: Bundle - Manufacturing, product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-product-manufacturing-pq-ex1"
},
"groupingId": "b5-mnf",
"description": "Example of Bundle - Manufacturing for drug product."
}, {
"name": "Example: Bundle - Manufacturing, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-product-manufacturing-pq-ex2-sub"
},
"groupingId": "b5-mnf",
"description": "Example of Bundle - Manufacturing for drug substance."
}, {
"name": "Profile: Bundle - Process Validation",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle - Process Validation",
"reference": "StructureDefinition/Bundle-product-process-validation-pq"
},
"groupingId": "b13-processvalidation",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.3 Manufacture, subsection 3.2.P.3.5 Process Validation and/or Evaluation and CTD section 3.2.S.2 Manufacture, subsection 3.2.S.2.5 Process Validation and/or Evaluation."
}, {
"name": "Example: Bundle - Process Validation, product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-product-process-validation-pq-ex1"
},
"groupingId": "b13-processvalidation",
"description": "Example of Bundle - Process Validation for drug product."
}, {
"name": "Example: Bundle - Process Validation, biologic product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-product-process-validation-pq-ex3-prod-bio"
},
"groupingId": "b13-processvalidation",
"description": "Example of Bundle - Process Validation for biologic drug product."
}, {
"name": "Example: Bundle - Process Validation, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-process-validation-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-product-process-validation-pq-ex2-sub"
},
"groupingId": "b13-processvalidation",
"description": "Example of Bundle - Process Validation for drug substance."
}, {
"name": "Profile: Bundle - Analytical Procedure",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Analytical Procedure",
"reference": "StructureDefinition/Bundle-analytical-procedure-pq"
},
"groupingId": "b6-analytical",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.2 Analytical Procedures and section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.2 Analytical Procedures."
}, {
"name": "Example: Bundle – Analytical Procedure, product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-analytical-procedure-pq-ex1-prod"
},
"groupingId": "b6-analytical",
"description": "Example of Bundle – Analytical Procedure for drug product."
}, {
"name": "Example: Bundle – Analytical Procedure, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-analytical-procedure-pq-ex2-sub"
},
"groupingId": "b6-analytical",
"description": "Example of Bundle – Analytical Procedure for drug substance."
}, {
"name": "Profile: Bundle - Container Closure System",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle - Container Closure System",
"reference": "StructureDefinition/Bundle-container-closure-system-pq"
},
"groupingId": "b10-container",
"description": "This Bundle profile represents the structured data in CTD sections 3.2.P.7 Container Closure System and 3.2.S.6 Container Closure System."
}, {
"name": "Example: Bundle - Container Closure System, product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-container-closure-system-pq-ex1-prod"
},
"groupingId": "b10-container",
"description": "Example of Bundle - Container Closure System for drug product."
}, {
"name": "Example: Bundle - Container Closure System, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-container-closure-system-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-container-closure-system-pq-ex2-sub"
},
"groupingId": "b10-container",
"description": "Example of Bundle - Container Closure System for drug substance."
}, {
"name": "Profile: Bundle - Stability",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Stability",
"reference": "StructureDefinition/Bundle-drug-stability-pq"
},
"groupingId": "b11-stabilitystudy",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.8 Stability, subsection 3.2.P.8.3 Stability Data, and CTD section 3.2.S.7 Stability, subsection 3.2.S.7.3 Stability Data."
}, {
"name": "Example: Bundle – Stability, product",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-stability-pq-ex1-prod"
},
"groupingId": "b11-stabilitystudy",
"description": "Example of Bundle – Stability for drug product."
}, {
"name": "Example: Bundle – Stability, substance",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-stability-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-stability-pq-ex2-sub"
},
"groupingId": "b11-stabilitystudy",
"description": "Example of Bundle – Stability for drug substance."
}, {
"name": "Profile: Bundle - Product Specification",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Product Specification",
"reference": "StructureDefinition/Bundle-drug-product-specification-pq"
},
"groupingId": "b12-specification",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.1 Specification(s)."
}, {
"name": "Profile: Bundle - Substance Specification",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle – Substance Specification",
"reference": "StructureDefinition/Bundle-drug-substance-specification-pq"
},
"groupingId": "b12-specification",
"description": "This Bundle profile represents the structured data in CTD section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.1 Specification."
}, {
"name": "Example: Bundle – Product Specification",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-product-specification-pq-ex1"
},
"groupingId": "b12-specification",
"description": "Example of Bundle – Product Specification."
}, {
"name": "Example: Bundle – Substance Specification",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-specification-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-substance-specification-pq-ex1"
},
"groupingId": "b12-specification",
"description": "Example of Bundle – Substance Specification."
}, {
"name": "Profile: Bundle - Product Compatibility",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Bundle - Product Compatibility",
"reference": "StructureDefinition/Bundle-drug-product-compatibility-pq"
},
"groupingId": "b14-compatibility",
"description": "This Bundle profile represents the structured data in CTD section 3.2.P.2 Pharmaceutical Development, subsection 3.2.P.2.6 Compatibility."
}, {
"name": "Example: Bundle – Product Compatibility",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-compatibility-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-compatibility-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"reference": {
"reference": "Bundle/bundle-drug-product-compatibility-pq-ex1"
},
"groupingId": "b14-compatibility",
"description": "Example of Bundle – Product Compatibility."
}, {
"name": "ActivityDefinition - Test",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "ActivityDefinition - Test",
"reference": "StructureDefinition/ActivityDefinition-test-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This ActivityDefinition profile represents a set of tests and their acceptance criteria through the contained ObservationDefinition resources."
}, {
"name": "Composition - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Composition - Drug",
"reference": "StructureDefinition/Composition-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Composition profile represents narrative text necessary for pharmaceutical quality (PQ) data exchange."
}, {
"name": "DeviceDefinition - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "DeviceDefinition - Drug",
"reference": "StructureDefinition/DeviceDefinition-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This DeviceDefinition profile represents information about devices and equipment used in pharmaceutical quality (PQ) data gathering."
}, {
"name": "DiagnosticReport - Drug Analysis",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "DiagnosticReport - Drug Analysis",
"reference": "StructureDefinition/DiagnosticReport-analysis-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This DiagnosticReport profile represents results from a batch analysis, stability study, characterization study, impurities analysis, manufacturing process validation study, etc."
}, {
"name": "DocumentReference - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "DocumentReference - Drug",
"reference": "StructureDefinition/DocumentReference-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This DocumentReference profile references a document of any kind, including a diagram or image, that is necessary for pharmaceutical quality (PQ) data exchange."
}, {
"name": "Ingredient - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Ingredient - Drug",
"reference": "StructureDefinition/Ingredient-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Ingredient profile represents the active ingredient(s) of a drug substance or product. It references one SubstanceDefinition resource and can include the strength or concentration of that substance."
}, {
"name": "ManufacturedItemDefinition - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "ManufacturedItemDefinition - Drug",
"reference": "StructureDefinition/ManufacturedItemDefinition-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This ManufacturedItemDefinition profile represents information about the physical packaged medication item, such as a tablet or capsule."
}, {
"name": "Medication - Batch Information",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Medication - Batch Information",
"reference": "StructureDefinition/Medication-batch-information-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Medication profile represents information about the batches that underwent testing or analysis."
}, {
"name": "MedicinalProductDefinition - Drug Product",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "MedicinalProductDefinition - Drug Product",
"reference": "StructureDefinition/MedicinalProductDefinition-drug-product-pq"
},
"groupingId": "building-blocks-1",
"description": "This MedicinalProductDefinition profile represents information that identifies the drug product."
}, {
"name": "Observation - Test Result",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Observation - Test Result",
"reference": "StructureDefinition/Observation-test-result-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Observation profile represents the result of a specific test defined by an ObservationDefinition resource."
}, {
"name": "ObservationDefinition - Test Method",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "ObservationDefinition - Test Method",
"reference": "StructureDefinition/ObservationDefinition-test-method-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This ObservationDefinition profile represents information about pharmaceutical quality (PQ) tests and acceptance criteria."
}, {
"name": "Organization - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Organization - Drug",
"reference": "StructureDefinition/Organization-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Organization profile represents information about a pharmaceutical company or site that performed drug testing or manufacturing."
}, {
"name": "PackagedProductDefinition - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "PackagedProductDefinition - Drug",
"reference": "StructureDefinition/PackagedProductDefinition-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This PackagedProductDefinition profile represents information about the packaging for a drug product or drug substance."
}, {
"name": "PlanDefinition - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "PlanDefinition - Drug",
"reference": "StructureDefinition/PlanDefinition-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This PlanDefinition profile represents a protocol, analytical procedure, manufacturing process, or other workflow definition used in pharmaceutical quality (PQ) data gathering."
}, {
"name": "Procedure - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Procedure - Drug",
"reference": "StructureDefinition/Procedure-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Procedure profile represents the actual performance of a manufacturing step, so that measurements can be recorded (via Observations), such as the actual “hold time” used, or the “bioburden” at the beginning or end of the step. The Procedure may record which device was used in the performance of a manufacturing step."
}, {
"name": "Specimen - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Specimen - Drug",
"reference": "StructureDefinition/Specimen-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Specimen profile represents identifying information about an individual specimen (an instance)."
}, {
"name": "SpecimenDefinition - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "SpecimenDefinition - Drug",
"reference": "StructureDefinition/SpecimenDefinition-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This SpecimenDefinition profile represents information about the treatment of a specimen, such as storage conditions and test duration."
}, {
"name": "Substance - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "Substance - Drug",
"reference": "StructureDefinition/Substance-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This Substance profile represents identifying information about an actual batch of aubstance (an instance)."
}, {
"name": "SubstanceDefinition - Component Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"display": "SubstanceDefinition - Component Drug",
"reference": "StructureDefinition/SubstanceDefinition-component-substance-drug-pq"
},
"groupingId": "building-blocks-1",
"description": "This SubstanceDefinition profile represents the chemical or biological details about a substance associated with an active ingredient (molecular weight, molecular formula, stereochemistry, protein or nucleic acid subunits)."
}, {
"name": "ActivityDefinition - Test - example 1",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ActivityDefinition"
} ],
"reference": {
"reference": "ActivityDefinition/activitydefinition-test-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ."
}, {
"name": "ActivityDefinition - Test - example 2",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ActivityDefinition-test-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ActivityDefinition"
} ],
"reference": {
"reference": "ActivityDefinition/LyophilizationAct"
},
"groupingId": "building-blocks-2",
"description": "Example of ActivityDefinition - Test for Lyophilization."
}, {
"name": "Composition - Drug - example, formulation",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"reference": {
"reference": "Composition/composition-drug-pq-formulation"
},
"groupingId": "building-blocks-2",
"description": "Example of Composition - Drug for formulation."
}, {
"name": "Composition - Drug - example, risk",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Composition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"reference": {
"reference": "Composition/composition-drug-pq-risk"
},
"groupingId": "building-blocks-2",
"description": "Example of Composition - Drug for risk."
}, {
"name": "DeviceDefinition - Drug - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DeviceDefinition"
} ],
"reference": {
"reference": "DeviceDefinition/devicedefinition-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of DeviceDefinition - Drug for a Rotating Impeller with 1.5mm screen."
}, {
"name": "DiagnosticReport - Drug Analysis - example, stability",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DiagnosticReport-analysis-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DiagnosticReport"
} ],
"reference": {
"reference": "DiagnosticReport/diagnosticreport-analysis-drug-pq-stability-prod"
},
"groupingId": "building-blocks-2",
"description": "Example of DiagnosticReport - Drug Analysis for stability study results report on a drug product."
}, {
"name": "DocumentReference - Drug - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DocumentReference-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DocumentReference-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
} ],
"reference": {
"reference": "DocumentReference/documentreference-drug-pq-process-flow-diagram"
},
"groupingId": "building-blocks-2",
"description": "Example of DocumentReference - Drug for process flow diagram."
}, {
"name": "Ingredient - Drug - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Ingredient-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
} ],
"reference": {
"reference": "Ingredient/ingredient-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of Ingredient - Drug containung one substance."
}, {
"name": "ManufacturedItemDefinition - Drug - example 1",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
} ],
"reference": {
"reference": "ManufacturedItemDefinition/manufactureditemdefinition-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of ManufacturedItemDefinition - Drug for an item contained by a closure system."
}, {
"name": "ManufacturedItemDefinition - Drug - example 2",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ManufacturedItemDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
} ],
"reference": {
"reference": "ManufacturedItemDefinition/manufactureditemdefinition-drug-pq-ex2"
},
"groupingId": "building-blocks-2",
"description": "Example of ManufacturedItemDefinition - Drug for Stelbatolol 5mg tablet."
}, {
"name": "Medication - Batch Information - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Medication"
} ],
"reference": {
"reference": "Medication/medication-batch-information-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of Medication - Batch Information for actual batch with lot number 33445."
}, {
"name": "MedicinalProductDefinition - Drug Product - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/MedicinalProductDefinition-drug-product-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
} ],
"reference": {
"reference": "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of MedicinalProductDefinition - Drug Product for Stelbat Tablets, 20mg."
}, {
"name": "Observation - Test Result - example 1",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-description"
},
"groupingId": "building-blocks-2",
"description": "Example of Observation - Test Result of Degradation Product 'Impurity 1' description from longTerm25X test."
}, {
"name": "Observation - Test Result - example 2",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-degradation-imp1"
},
"groupingId": "building-blocks-2",
"description": "Example of Observation - Test Result of Degradation Product 'Impurity 1' qualtity from longTerm25X test."
}, {
"name": "ObservationDefinition - Test Method - example 1, longTerm25X",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/longTerm25X"
},
"groupingId": "building-blocks-2",
"description": "Example of ObservationDefinition - Test Method for longTerm25X test for stability."
}, {
"name": "ObservationDefinition - Test Method - example 2, Water",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Water"
},
"groupingId": "building-blocks-2",
"description": "Example of ObservationDefinition - Test Method for Water Content test method."
}, {
"name": "Organization - Drug - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Organization-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"reference": {
"reference": "Organization/organization-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of Organization - Drug."
}, {
"name": "PackagedProductDefinition - Drug - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PackagedProductDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PackagedProductDefinition"
} ],
"reference": {
"reference": "PackagedProductDefinition/packagedproductdefinition-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of PackagedProductDefinition - Drug."
}, {
"name": "PlanDefinition - Drug - example, validation protocol",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"reference": {
"reference": "PlanDefinition/plandefinition-drug-pq-ex1-validation-protocol"
},
"groupingId": "building-blocks-2",
"description": "Example of PlanDefinition - Drug for validation protocol."
}, {
"name": "PlanDefinition - Drug - example, manufacturing plan",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"reference": {
"reference": "PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan"
},
"groupingId": "building-blocks-2",
"description": "Example of PlanDefinition - Drug for manufacturing plan"
}, {
"name": "PlanDefinition - Drug - example, drug specification",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"reference": {
"reference": "PlanDefinition/plandefinition-drug-pq-ex3-drug-specification"
},
"groupingId": "building-blocks-2",
"description": "Example of PlanDefinition - Drug for drug specification."
}, {
"name": "PlanDefinition - Drug - example, manufacturing process",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"reference": {
"reference": "PlanDefinition/plandefinition-drug-pq-ex4-mnf-process"
},
"groupingId": "building-blocks-2",
"description": "Example of PlanDefinition - Drug for manufacturing process."
}, {
"name": "PlanDefinition - Drug - example, stability study protocol",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"reference": {
"reference": "PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol"
},
"groupingId": "building-blocks-2",
"description": "Example of PlanDefinition - Drug for stability study protocol."
}, {
"name": "Procedure - Drug - example 1",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Procedure"
} ],
"reference": {
"reference": "Procedure/procedure-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of Procedure - Drug for Media Challenge, Run 1."
}, {
"name": "Procedure - Drug - example 2",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Procedure-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Procedure"
} ],
"reference": {
"reference": "Procedure/procedure-drug-pq-ex2"
},
"groupingId": "building-blocks-2",
"description": "Example of Procedure - Drug for Lyophilization Homogeneneity."
}, {
"name": "Specimen - Drug - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Specimen-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Specimen"
} ],
"reference": {
"reference": "Specimen/specimen-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of Specimen - Drug with collection date/time and processing descriptions."
}, {
"name": "SpecimenDefinition - Drug - example 1",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SpecimenDefinition"
} ],
"reference": {
"reference": "SpecimenDefinition/specimendefinition-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of SpecimenDefinition - Drug for specimen stored at 25°C."
}, {
"name": "SpecimenDefinition - Drug - example 2",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SpecimenDefinition"
} ],
"reference": {
"reference": "SpecimenDefinition/specimenDefStoredAt30"
},
"groupingId": "building-blocks-2",
"description": "Example of SpecimenDefinition - Drug for specimen stored at 30°C."
}, {
"name": "SpecimenDefinition - Drug - example 3",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SpecimenDefinition-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SpecimenDefinition"
} ],
"reference": {
"reference": "SpecimenDefinition/specimenDefStoredAt40"
},
"groupingId": "building-blocks-2",
"description": "Example of SpecimenDefinition - Drug for specimen stored at 40°C."
}, {
"name": "Substance - Drug - example",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Substance-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Substance"
} ],
"reference": {
"reference": "Substance/substance-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of Substance - Drug."
}, {
"name": "SubstanceDefinition - Component Drug - example 1",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"reference": {
"reference": "SubstanceDefinition/substancedefinition-component-substance-drug-pq-ex1"
},
"groupingId": "building-blocks-2",
"description": "Example of SubstanceDefinition - Component Drug, Stelbatolol."
}, {
"name": "SubstanceDefinition - Component Drug - example 2",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"reference": {
"reference": "SubstanceDefinition/StelbatololAqueousSolution"
},
"groupingId": "building-blocks-2",
"description": "Example of SubstanceDefinition - Component Drug, Stelbatolol Aqueous Solution."
}, {
"name": "SubstanceDefinition - Component Drug - example 3",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"reference": {
"reference": "SubstanceDefinition/StelbatololGranules"
},
"groupingId": "building-blocks-2",
"description": "Example of SubstanceDefinition - Component Drug, Stelbatolol Granules."
}, {
"name": "Extension - Actual Yield",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Actual Yield",
"reference": "StructureDefinition/Extension-actual-yield-pq"
},
"groupingId": "extensions1",
"description": "The actual weight of a batch"
}, {
"name": "Extension - Actual Yield Unfiltered",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Actual Yield Unfiltered",
"reference": "StructureDefinition/Extension-actual-yield-unfiltered-pq"
},
"groupingId": "extensions1",
"description": "The actual weight of a batch, before filtering"
}, {
"name": "Extension - Batch Derived From",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Derived From",
"reference": "StructureDefinition/Extension-batch-derived-from-pq"
},
"groupingId": "extensions1",
"description": "A reference to another batch that this batch is derived from"
}, {
"name": "Extension - Batch Designation",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Designation",
"reference": "StructureDefinition/Extension-batch-designation-pq"
},
"groupingId": "extensions1",
"description": "A batch's type in terms of its general size"
}, {
"name": "Extension - Batch Number of Full Shelves",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Number of Full Shelves",
"reference": "StructureDefinition/Extension-batch-number-of-full-shelves-pq"
},
"groupingId": "extensions1",
"description": "The count of full shelves from which batches are selected for testing"
}, {
"name": "Extension - Batch Number of Partial Shelves",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Number of Partial Shelves",
"reference": "StructureDefinition/Extension-batch-number-of-partial-shelves-pq"
},
"groupingId": "extensions1",
"description": "The number of partially filled shelves from which batches are selected for testing"
}, {
"name": "Extension - Batch Number of Vials",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Number of Vials",
"reference": "StructureDefinition/Extension-batch-number-of-vials-pq"
},
"groupingId": "extensions1",
"description": "The count of vials selected for testing"
}, {
"name": "Extension - Batch Release Date",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Release Date",
"reference": "StructureDefinition/Extension-batch-release-date-pq"
},
"groupingId": "extensions1",
"description": "The date when a batch was made available"
}, {
"name": "Extension - Batch Retest Date",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Retest Date",
"reference": "StructureDefinition/Extension-batch-retest-date-pq"
},
"groupingId": "extensions1",
"description": "The date that a batch is due to be tested again"
}, {
"name": "Extension - Batch Storage Duration",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Storage Duration",
"reference": "StructureDefinition/Extension-batch-storage-duration-pq"
},
"groupingId": "extensions1",
"description": "The length of time for which a batch is stored, before being tested"
}, {
"name": "Extension - Batch Substance Batch",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Batch Substance Batch",
"reference": "StructureDefinition/Extension-batch-substance-batch-pq"
},
"groupingId": "extensions1",
"description": "A reference to a substance that this batch consists of"
}, {
"name": "Extension - Container Orientation",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Container Orientation",
"reference": "StructureDefinition/Extension-container-orientation-pq"
},
"groupingId": "extensions1",
"description": "The spatial orientaton of the container when tested, for instance horizontal or vertical"
}, {
"name": "Extension - Formulation Number",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Formulation Number",
"reference": "StructureDefinition/Extension-formulation-number-pq"
},
"groupingId": "extensions1",
"description": "An identifying number for the particular substance formulation in the batch"
}, {
"name": "Extension - History of Process",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - History of Process",
"reference": "StructureDefinition/Extension-history-of-process-pq"
},
"groupingId": "extensions1",
"description": "An textual description of the previous versions, decisions and development of this process"
}, {
"name": "Extension - Impurity Origin",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/Extension-impurity-origin-pq"
},
"groupingId": "extensions1",
"description": "Extension - Impurity Origin"
}, {
"name": "Extension - Manufacturing Participant",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Manufacturing Participant",
"reference": "StructureDefinition/Extension-manufacturing-participant-pq"
},
"groupingId": "extensions1",
"description": "A reference to a substance that takes part in a process step"
}, {
"name": "Extension - Manufacturing Process",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Manufacturing Process",
"reference": "StructureDefinition/Extension-manufacturing-process-pq"
},
"groupingId": "extensions1",
"description": "A reference to the process of manufacture of this batch (PlanDefinition)"
}, {
"name": "Extension - Medication Definition",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Medication Definition",
"reference": "StructureDefinition/Extension-medication-definition-pq"
},
"groupingId": "extensions1",
"description": "The MedicinalProductDefinition that corresponds to a medication"
}, {
"name": "Extension - Novel Excipient",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Novel Excipient",
"reference": "StructureDefinition/Extension-novel-excipient-pq"
},
"groupingId": "extensions1",
"description": "Whether or not an excipient (inactive ingredient) in a product is considered 'novel'"
}, {
"name": "Extension - Package Definition",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Package Definition",
"reference": "StructureDefinition/Extension-package-definition-pq"
},
"groupingId": "extensions1",
"description": "A reference to the packaging for a medication (PackagedProductDefinition)"
}, {
"name": "Extension - Packaging Date",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Packaging Date",
"reference": "StructureDefinition/Extension-packaging-date-pq"
},
"groupingId": "extensions1",
"description": "The date when the batch was packaged"
}, {
"name": "Extension - Packaging Site",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Packaging Site",
"reference": "StructureDefinition/Extension-packaging-site-pq"
},
"groupingId": "extensions1",
"description": "The organization that packaged this batch (reference to an Organization)"
}, {
"name": "Extension - Plan Document Reference",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Plan Document Reference",
"reference": "StructureDefinition/Extension-plan-document-reference-pq"
},
"groupingId": "extensions1",
"description": "A link to a doucment, or image, that describes the process of this plan"
}, {
"name": "Extension - Process Parameters",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Process Parameters",
"reference": "StructureDefinition/Extension-process-parameters-pq"
},
"groupingId": "extensions1",
"description": "A property value or setting that this process step must use e.g. a certain temperature or duration"
}, {
"name": "Extension - Process Step Scale",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Process Step Scale",
"reference": "StructureDefinition/Extension-process-step-scale-pq"
},
"groupingId": "extensions1",
"description": "A scale size description that applies to a process step, such as 'production' or 'laboratory'"
}, {
"name": "Extension - Qualified Value Criticality",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Qualified Value Criticality",
"reference": "StructureDefinition/Extension-qualified-value-criticality-pq"
},
"groupingId": "extensions1",
"description": "A measure of how important the control value of this process step is"
}, {
"name": "Extension - Qualified Value Display",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Qualified Value Display",
"reference": "StructureDefinition/Extension-qualified-value-display-pq"
},
"groupingId": "extensions1",
"description": "A displayable version of a qualified value, formatted for showing to a user"
}, {
"name": "Extension - Qualified Value Target",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Qualified Value Target",
"reference": "StructureDefinition/Extension-qualified-value-target-pq"
},
"groupingId": "extensions1",
"description": "A target, desired, amount for a qualified value, from within the allowable range"
}, {
"name": "Extension - Qualified Value Text",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Qualified Value Text",
"reference": "StructureDefinition/Extension-qualified-value-text-pq"
},
"groupingId": "extensions1",
"description": "A string based acceptable range description"
}, {
"name": "Extension - Site Utilization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Site Utilization",
"reference": "StructureDefinition/Extension-site-utilization-pq"
},
"groupingId": "extensions1",
"description": "The role that the site performs, in the overall context of manufacturing"
}, {
"name": "Extension - Statistical Model",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Statistical Model",
"reference": "StructureDefinition/Extension-statistical-model-pq"
},
"groupingId": "extensions1",
"description": "Information about the statistical model utilized to interpret results"
}, {
"name": "Extension - Substance Property Parameter",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Substance Property Parameter",
"reference": "StructureDefinition/Extension-substance-property-parameter-pq"
},
"groupingId": "extensions1",
"description": "A parameter to a substance property, such as the concentration or pH at which the property value applies"
}, {
"name": "Extension - Substance Property Range",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Substance Property Range",
"reference": "StructureDefinition/Extension-substance-property-range-pq"
},
"groupingId": "extensions1",
"description": "Allows a characteristic or property to use a range datatype, instead of a single value"
}, {
"name": "Extension - Suitability For Use",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Suitability For Use",
"reference": "StructureDefinition/Extension-suitability-for-use-pq"
},
"groupingId": "extensions1",
"description": "Whether an excipient is considered suitable for use in this product or item"
}, {
"name": "Extension - Target Fill Weight",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Target Fill Weight",
"reference": "StructureDefinition/Extension-target-fill-weight-pq"
},
"groupingId": "extensions1",
"description": "The desired amount of substance in each item to be made from the batch (e.g. a vial)"
}, {
"name": "Extension - Test Comment",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Test Comment",
"reference": "StructureDefinition/Extension-test-comment-pq"
},
"groupingId": "extensions1",
"description": "A textual comment that further describes an aspect of a test requirement"
}, {
"name": "Extension - Time Point Description",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"display": "Extension - Time Point Description",
"reference": "StructureDefinition/Extension-time-point-description-pq"
},
"groupingId": "extensions1",
"description": "A code that further describes a time point, such as 'delayed start'"
}, {
"name": "accelerated40X",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/accelerated40X"
},
"groupingId": "examples1",
"description": "ObservationDefinition - accelerated40X"
}, {
"name": "accelerated40Y",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/accelerated40Y"
},
"groupingId": "examples1",
"description": "ObservationDefinition - accelerated40Y"
}, {
"name": "accelerated40Z",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/accelerated40Z"
},
"groupingId": "examples1",
"description": "ObservationDefinition - accelerated40Z"
}, {
"name": "longTerm25Y",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/longTerm25Y"
},
"groupingId": "examples1",
"description": "ObservationDefinition - longTerm25Y"
}, {
"name": "longTerm25Z",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/longTerm25Z"
},
"groupingId": "examples1",
"description": "ObservationDefinition - longTerm25Z"
}, {
"name": "longTerm30X",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/longTerm30X"
},
"groupingId": "examples1",
"description": "ObservationDefinition - longTerm30X"
}, {
"name": "longTerm30Y",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/longTerm30Y"
},
"groupingId": "examples1",
"description": "ObservationDefinition - longTerm30Y"
}, {
"name": "Assay",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Assay"
},
"groupingId": "examples1",
"description": "ObservationDefinition - Assay"
}, {
"name": "Degradation",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Degradation"
},
"groupingId": "examples1",
"description": "ObservationDefinition - Degradation"
}, {
"name": "Description",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Description"
},
"groupingId": "examples1",
"description": "ObservationDefinition - Description"
}, {
"name": "Identification",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Identification"
},
"groupingId": "examples1",
"description": "ObservationDefinition - Identification"
}, {
"name": "Impurities",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Impurities"
},
"groupingId": "examples1",
"description": "ObservationDefinition - Impurities"
}, {
"name": "Microbiological",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Microbiological"
},
"groupingId": "examples1",
"description": "ObservationDefinition - Microbiological"
}, {
"name": "Uniformity",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/ObservationDefinition-test-method-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ObservationDefinition"
} ],
"reference": {
"reference": "ObservationDefinition/Uniformity"
},
"groupingId": "examples1",
"description": "ObservationDefinition - Uniformity"
}, {
"name": "observation-test-result-longterm25c-initial-1",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-longterm25c-initial-1"
},
"groupingId": "examples4",
"description": "observation-test-result-longterm25c-initial-1"
}, {
"name": "observation-test-result-lt25c-i1-degradation-imp2",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-degradation-imp2"
},
"groupingId": "examples4",
"description": "observation-test-result-lt25c-i1-degradation-imp2"
}, {
"name": "observation-test-result-lt25c-i1-degradation-imp3",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-degradation-imp3"
},
"groupingId": "examples4",
"description": "observation-test-result-lt25c-i1-degradation-imp3"
}, {
"name": "observation-test-result-lt25c-i1-degradation-imp-total",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-degradation-imp-total"
},
"groupingId": "examples4",
"description": "observation-test-result-lt25c-i1-degradation-imp-total"
}, {
"name": "observation-test-result-lt25c-i1-degradation-imp-unspecified",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-degradation-imp-unspecified"
},
"groupingId": "examples4",
"description": "observation-test-result-lt25c-i1-degradation-imp-unspecified"
}, {
"name": "observation-test-result-lt25c-i1-microbiological",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-microbiological"
},
"groupingId": "examples4",
"description": "observation-test-result-lt25c-i1-microbiological"
}, {
"name": "observation-test-result-lt25c-i1-uniformity",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-uniformity"
},
"groupingId": "examples4",
"description": "observation-test-result-lt25c-i1-uniformity"
}, {
"name": "observation-test-result-lt25c-i1-water",
"profile": [ "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq", "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Observation"
} ],
"reference": {
"reference": "Observation/observation-test-result-lt25c-i1-water"
},
"groupingId": "examples4",
"description": "observation-test-result-lt25c-i1-water"
}, {
"name": "Closure Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/pqcmc-closure-type-terminology"
},
"description": "Terminology used to qualify the information pertaining to closure types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "CodeSystem - Batch Designation",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-batch-designation-local-pq"
},
"description": "This code system contains example codes for batch designation in PQ."
}, {
"name": "CodeSystem - Characterization Step",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-characterizationStep-local-pq"
},
"description": "This code system contains example codes for characterization step in PQ."
}, {
"name": "CodeSystem - Closure Types",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-closureTypes-local-pq"
},
"description": "This code system contains example codes for closure types in PQ."
}, {
"name": "CodeSystem - Color",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-color-local-pq"
},
"description": "This code system contains example codes for color in PQ."
}, {
"name": "CodeSystem - Container Orientation",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-containerOrientation-local-pq"
},
"description": "This code system contains example codes for container orientation in PQ."
}, {
"name": "CodeSystem - Control Criticality",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-controlCriticality-local-pq"
},
"description": "This code system contains example codes for control criticality in PQ."
}, {
"name": "CodeSystem - Device Property",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-deviceProperty-local-pq"
},
"description": "This code system contains example codes for device property in PQ."
}, {
"name": "CodeSystem - Device Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-deviceType-local-pq"
},
"description": "This code system contains example codes for device type in PQ."
}, {
"name": "CodeSystem - Diagram Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-diagramType-local-pq"
},
"description": "This code system contains example codes for diagram type in PQ."
}, {
"name": "CodeSystem - Equipment Class",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-equipmentClass-local-pq"
},
"description": "This code system contains example codes for equipment class in PQ."
}, {
"name": "CodeSystem - Goal Priority",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-goalPriority-local-pq"
},
"description": "This code system contains example codes for goal priority in PQ."
}, {
"name": "CodeSystem - Grade",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-grade-local-pq"
},
"description": "This code system contains example codes for grade in PQ."
}, {
"name": "CodeSystem - ICH M7 Classification",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-ich-m7-classification-local-pq"
},
"description": "This code system contains example codes for ICH M7 classification in PQ."
}, {
"name": "CodeSystem - Impurity Origin",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-impurity-origin-local-pq"
},
"description": "This code system contains example codes for impurity origin in PQ."
}, {
"name": "CodeSystem - Impurity Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-impurity-type-local-pq"
},
"description": "This code system contains example codes for impurity type in PQ."
}, {
"name": "CodeSystem - Ingredient Function",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-ingredientFunction-local-pq"
},
"description": "This code system contains example codes for ingredient function in PQ."
}, {
"name": "CodeSystem - Example Local Codes - Drug",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-local-codes-drug-pq"
},
"description": "This code system contains temporary example codes for use in PQ."
}, {
"name": "CodeSystem - Manufactured Item Property",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-manufactured-item-property-local-pq"
},
"description": "This code system contains example codes for manufactured item property in PQ."
}, {
"name": "CodeSystem - Manufacturing Participant Role",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-manufacturingParticipantRole-local-pq"
},
"description": "This code system contains example codes for manufacturing participant role in PQ."
}, {
"name": "CodeSystem - Manufacturing Step",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-manufacturingStep-local-pq"
},
"description": "This code system contains example codes for manufacturing step in PQ."
}, {
"name": "CodeSystem - Manufacturing Step Scale",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-manufacturingStepScale-local-pq"
},
"description": "This code system contains example codes for manufacturing step scale in PQ."
}, {
"name": "CodeSystem - Mutagenicity",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-mutagenicity-local-pq"
},
"description": "This code system contains example codes for mutagenicity in PQ."
}, {
"name": "CodeSystem - Mutagenicity Classification Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-mutagenicityClassificationType-local-pq"
},
"description": "This code system contains example codes for mutagenicity classification type in PQ."
}, {
"name": "CodeSystem - Package Property",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-packageProperty-local-pq"
},
"description": "This code system contains example codes for package property in PQ."
}, {
"name": "CodeSystem - Plan Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-planType-local-pq"
},
"description": "This code system contains example codes for plan type in PQ."
}, {
"name": "CodeSystem - Process Parameter",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-processParameter-local-pq"
},
"description": "This code system contains example codes for process parameter in PQ."
}, {
"name": "CodeSystem - Product Name Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-productNameType-local-pq"
},
"description": "This code system contains example codes for product name type in PQ."
}, {
"name": "CodeSystem - Product Site Utilization Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-productSiteUtilizationType-local-pq"
},
"description": "This code system contains example codes for product site utilization type in PQ."
}, {
"name": "CodeSystem - Qualified Value Criticality",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-qualifiedValueCriticality-local-pq"
},
"description": "This code system contains example codes for qualified value criticality in PQ."
}, {
"name": "CodeSystem - Report Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-reportType-local-pq"
},
"description": "This code system contains example codes for report type in PQ."
}, {
"name": "CodeSystem - Specification Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-specification-type-local-pq"
},
"description": "This code system contains example codes for specification type in PQ."
}, {
"name": "CodeSystem - Substance Property",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-substance-property-local-pq"
},
"description": "This code system contains example codes for substance property in PQ."
}, {
"name": "CodeSystem - Substance Property Solubility",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-substance-property-solubility-local-pq"
},
"description": "This code system contains example codes for substance property solubility in PQ."
}, {
"name": "CodeSystem - Substance Property Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-substancePropertyType-local-pq"
},
"description": "This code system contains example codes for substance property type in PQ."
}, {
"name": "CodeSystem - Test Category",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-testCategory-local-pq"
},
"description": "This code system contains example codes for test category in PQ."
}, {
"name": "CodeSystem - Time Point Description",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"reference": {
"reference": "CodeSystem/cs-timePointDescription-local-pq"
},
"description": "This code system contains example codes for time point description in PQ."
}, {
"name": "MedicinalProduct Characteristic Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/medicinalproduct-characteristic-type"
},
"description": "Example codes for MedicinalProduct.characteristic.type"
}, {
"name": "Medicine Dose Form EDQM",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/medicine-doseform"
},
"description": "EDQM (European Directorate for the Quality of Medicines and Healthcare) Dose Form codes. This Value Set includes all the EDQM Standard Terms having: \n[Concept Status] = ‘Current’ AND \n[Concept Class] IN (‘PDF’, ‘CMT’, ‘CDF’, ‘PFT') AND \n[Domain] = 'Human and Veterinary' \n\nPDF = 'Pharmaceutical dose form'; CMT = 'Combined terms'; CDF = 'Combined pharmaceutical dose form'; PFT = 'Patient Friendly'"
}, {
"name": "Medicine Route of Administration EDQM",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/medicine-route-of-administration"
},
"description": "EDQM (European Directorate for the Quality of Medicines and Healthcare) Route of Administration codes. This Value Set includes all the EDQM Standard Terms having: \n[Concept Status] = ‘Current’ AND \n[Concept Class] = 'ROA' AND \n[Domain] = 'Human and Veterinary' \n\nROA = 'Route of administration'"
}, {
"name": "ValueSet - Batch Designation",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-batch-designation-local-pq"
},
"description": "This value set contains example codes for batch designation in PQ."
}, {
"name": "ValueSet - Container Orientation",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-containerOrientation-local-pq"
},
"description": "This value set contains example codes for container orientation in PQ."
}, {
"name": "ValueSet - Device Property",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-deviceProperty-local-pq"
},
"description": "This value set contains example codes for device property in PQ."
}, {
"name": "ValueSet - Device Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-deviceType-local-pq"
},
"description": "This valueset contains example codes for device type in PQ."
}, {
"name": "ValueSet - Impurity Origin",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-impurity-origin-local-pq"
},
"description": "This value set contains example codes for impurity origin in PQ."
}, {
"name": "ValueSet - Ingredient Function",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-ingredientFunction-local-pq"
},
"description": "This value set contains example codes for ingredient function in PQ."
}, {
"name": "ValueSet - Manufactured Item Property",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-manufactured-item-property-local-pq"
},
"description": "This value set contains example codes for manufactured item property in PQ."
}, {
"name": "ValueSet - Manufacturing Step",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-manufacturingStep-local-pq"
},
"description": "This value set contains example codes for manufacturing step in PQ."
}, {
"name": "ValueSet - Manufacturing Step Scale",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-manufacturingStepScale-local-pq"
},
"description": "This value set contains example codes for manufacturing step scale in PQ."
}, {
"name": "ValueSet - Package Property",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-packageProperty-local-pq"
},
"description": "This value set contains example codes for package property in PQ."
}, {
"name": "ValueSet - Plan Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-planType-local-pq"
},
"description": "This value set contains example codes for plan type in PQ."
}, {
"name": "ValueSet - Process Validation Procedure",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-process-validation-procedure-pq"
},
"description": "This value set contains example process validation procedure codes for use in PQ."
}, {
"name": "ValueSet - Product Site Utilization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-productSiteUtilizationType-local-pq"
},
"description": "This value set contains example codes for product site utilization type in PQ."
}, {
"name": "ValueSet - Qualified Value Criticality",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-qualifiedValueCriticality-local-pq"
},
"description": "This value set contains example codes for qualified value criticality in PQ."
}, {
"name": "ValueSet - Test Method",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-test-method-local-pq"
},
"description": "This value set contains example codes for test methods in PQ."
}, {
"name": "ValueSet - Time Point Description",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"reference": {
"reference": "ValueSet/vs-timePointDescription-local-pq"
},
"description": "This value set contains example codes for time point description in PQ."
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
"valueCode": "hl7.fhir.uv.tools#current"
} ],
"parameter": [ {
"code": {
"code": "releaselabel",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "ballot"
}, {
"code": {
"code": "special-url",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://hl7.org/fhir/us/pq-cmc/ValueSet/pqcmc-closure-type-terminology"
}, {
"code": {
"code": "autoload-resources",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/capabilities"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/examples"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/extensions"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/models"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/operations"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/profiles"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/resources"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/vocabulary"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/maps"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/testing"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/history"
}, {
"code": {
"code": "path-resource",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "fsh-generated/resources"
}, {
"code": {
"code": "path-pages",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "template/config"
}, {
"code": {
"code": "path-pages",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input/images"
}, {
"code": {
"code": "path-liquid",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "template/liquid"
}, {
"code": {
"code": "path-liquid",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "input/liquid"
}, {
"code": {
"code": "path-qa",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "temp/qa"
}, {
"code": {
"code": "path-temp",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "temp/pages"
}, {
"code": {
"code": "path-output",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "output"
}, {
"code": {
"code": "path-tx-cache",
"system": "http://hl7.org/fhir/guide-parameter-code"
},
"value": "input-cache/txcache"
}, {
"code": {
"code": "path-suppressed-warnings",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "input/ignoreWarnings.txt"
}, {
"code": {
"code": "path-history",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://hl7.org/fhir/uv/pharm-quality/history.html"
}, {
"code": {
"code": "template-html",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "template-page.html"
}, {
"code": {
"code": "template-md",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "template-page-md.html"
}, {
"code": {
"code": "apply-contact",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
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