{
"description": "The FDA PQ-CMC FHIR IG is for submission of structured and standardized information regarding drug product quality, chemistry, manufacturing and processes controls. This data is intended for submission to the US FDA by biopharmaceutical companies for the purpose of drug application review.",
"_filename": "ImplementationGuide-hl7.fhir.us.pq-cmc-fda.json",
"package_name": "hl7.fhir.us.pq-cmc-fda",
"definition": {
"page": {
"name": "toc.html",
"page": [ {
"name": "index.html",
"title": "Home",
"sourceUrl": "index.html",
"generation": "markdown"
}, {
"name": "instruction.html",
"title": "General Instructions",
"sourceUrl": "instruction.html",
"generation": "markdown"
}, {
"name": "eCTD32S10.html",
"title": "General Information (3.2.S.1)",
"sourceUrl": "eCTD32S10.html",
"generation": "markdown"
}, {
"name": "eCTD32S23.html",
"title": "Substance Control of Materials (3.2.S.2.3)",
"sourceUrl": "eCTD32S23.html",
"generation": "markdown"
}, {
"name": "eCTDSP4151.html",
"title": "Specification (3.2.S.4.1, 3.2.P.4 and 3.2.P.5.1)",
"sourceUrl": "eCTDSP4151.html",
"generation": "markdown"
}, {
"name": "eCTD32P10.html",
"title": "Description and Composition of the Drug Product (3.2.P.1)",
"sourceUrl": "eCTD32P10.html",
"generation": "markdown"
}, {
"name": "artifacts.html",
"title": "Artifact List",
"sourceUrl": "artifacts.html",
"generation": "html"
}, {
"name": "downloads.html",
"title": "Downloads",
"sourceUrl": "downloads.html",
"generation": "markdown"
}, {
"name": "change_notes.html",
"title": "Change Notes",
"sourceUrl": "change_notes.html",
"generation": "markdown"
} ],
"title": "Table of Contents",
"sourceUrl": "toc.html",
"generation": "html"
},
"resource": [ {
"name": "7cdbb042-9275-4599-a1fe-08877846bf94",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"isExample": true,
"reference": {
"reference": "Bundle/7cdbb042-9275-4599-a1fe-08877846bf94"
},
"description": "FHIR document bundle with the CMC eCTD SP4151 profile for an Excipient"
}, {
"name": "Additional Information",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-additional-info-extension"
},
"description": "Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG."
}, {
"name": "Amount Ratio",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-amount-ratio"
},
"description": "represent an amount as a ratio in ManufacturedItemDefinition"
}, {
"name": "Analysis Graphic",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-graphic-attachment"
},
"description": "Any attached file that contains a graphical representation"
}, {
"name": "Analytical Instrument Data",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-analytical-intstrument-data"
},
"description": "Any attached file that contains analytical instrument data"
}, {
"name": "Analytical Instrument Data File Types",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-analytical-instrument-data-types"
},
"description": "The acceptable file types that can be used in Analytical Instrument Data Files"
}, {
"name": "Attached Document (PDF)",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-pdf-attachment"
},
"description": "An attached PDF file"
}, {
"name": "Basic Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-organization"
},
"description": "A profile for the data elements required to identify the sponsor of the drug products or substances, Suppliers."
}, {
"name": "Batch utilization Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-batch-utilization-terminology"
},
"description": "Terminology used to qualify the information pertaining to batch utilization in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Bundle for 3.2.S.1",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s10" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"isExample": true,
"reference": {
"reference": "Bundle/30536c0e-456c-4f90-9f02-da7be1d289e9"
},
"description": "Bundle containng nomenclature and molecular structure"
}, {
"name": "Capsule Shell Classification Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/capsule-classification-category"
},
"description": "A category of terminology used to qualify the information pertaining to the classification of a capsule in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Chemical Structure Data File Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-chemical-structure-datafile-type-terminology"
},
"description": "Terminology used to qualify the information pertaining to chemical structure data file types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Closure Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"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": "CMC eCTD 32P10 Document",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-ectd-document-32p10"
},
"description": "Definition for a document bundle with the CMC eCTD 32P1 profiles."
}, {
"name": "CMC eCTD 32S10 Document",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-ectd-document-32s10"
},
"description": "Definition for a document bundle with the CMC eCTD 32S1 profiles."
}, {
"name": "CMC eCTD 32S23 Document",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-ectd-document-32s23"
},
"description": "Definition for a document bundle with the CMC eCTD 32S23 profiles."
}, {
"name": "CMC eCTD SP4151 Document",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-ectd-document-sp4151"
},
"description": "Definition for a document bundle with the CMC eCTD SP4151 profiles."
}, {
"name": "CMCeCTDDocument32P10 bundle",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p10" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"isExample": true,
"reference": {
"reference": "Bundle/bd0f0a7a-27ea-4884-801d-bd0546e80888"
},
"description": "A bundle for 3.2.P.1.0"
}, {
"name": "Coating Purpose Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-coating-purpose"
},
"description": "A category of terminology used to qualify the information pertaining to the coating purpose in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Component Substance",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-component-substance"
},
"description": "Any raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product."
}, {
"name": "Container Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-container-type-terminology"
},
"description": "Terminology used to qualify the information pertaining to container types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "ContainerClosure",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/ContainerClosure"
},
"description": "Container Closure for drug product referred to in Drug Product Description."
}, {
"name": "Document Reference Attachment",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-document-reference"
},
"description": "A profile that represents the document or diagram in base64."
}, {
"name": "Drug Product Component",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-component"
},
"description": "The amount details about the drug product components to define the product composition in a product unit. Use composition."
}, {
"name": "Drug Product Component Function Category Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-drug-product-component-function-category-terminology"
},
"description": "Terminology used to qualify the information pertaining to drug product component function categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Drug Product Description",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-drug-product-description"
},
"description": "Includes the properties of the drug product and components. Profile of Drug Product profile."
}, {
"name": "Drug Product Handle",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-drug-product-handle"
},
"description": "Includes the essential identifying information of the drug product required to link to other profiles about the product in the eCTD structure."
}, {
"name": "Drug Route Of Administration Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/spl-drug-route-of-administration-terminology"
},
"description": "Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents."
}, {
"name": "Drug Substance Handle",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-routine-drug-substance"
},
"description": "Provides sufficient information to identify a drug substance. Profile on SubstanceDefinition."
}, {
"name": "eCTD Document for 32S23",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32s23" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"isExample": true,
"reference": {
"reference": "Bundle/7ce2088d-d281-4e2f-9a25-120a1f9805d1"
},
"description": "This is an example of the Substance Control of Materials bundle profile. It is to submit Module 3 of CTD 3.2.S.2.3 folder content to the FDA."
}, {
"name": "eCTD Product Description and Composition",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/ectd-composition-32p10"
},
"description": "The fields needed to represent the Product Description, Container Closure and Composition of the Drug Product to be included under the 3.2.P.1 heading of the eCTD. References Sponsor Organization, Drug Product Description, and Product Container Closure System."
}, {
"name": "eCTD sections Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/cmc-comp-section-types-vs"
},
"description": "Value set of all codes in Code system PQCMC Comp Section Types."
}, {
"name": "eCTD Specification Composition",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/ectd-composition-sp4151"
},
"description": "The fields needed to represent Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials."
}, {
"name": "eCTD Substance Control of Materials Composition",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/ectd-composition-32s23"
},
"description": "The fields needed to represent the Substance Control of Materials to be included under the eCTD 3.2.S.2.3 heading. References Sponsor Organization and Drug Substance Materials."
}, {
"name": "eCTD Substance General Information",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/ectd-composition-32s10"
},
"description": "The fields needed to represent the Substance Nomenclature and Structure to be included under the 3.2.S.1 heading of the eCTD. References Sponsor Organization."
}, {
"name": "Excipient Drug Substance",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-excipient"
},
"description": "Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission."
}, {
"name": "Excipient Function Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-excipient-function-terminology"
},
"description": "Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "FHIR Document example of 3.2.P.5.1.",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"isExample": true,
"reference": {
"reference": "Bundle/4a7e17c1-a611-4cc7-9a71-8005a8b427ab"
},
"description": "FHIR document bundle with the CMC eCTD SP4151 profile for a Drug Product"
}, {
"name": "FHIR Document example of 3.2.S.4.1.",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
} ],
"isExample": true,
"reference": {
"reference": "Bundle/6004e36e-7df9-469d-9b29-8e9f9bd7e95f"
},
"description": "FHIR document bundle with the CMC eCTD SP4151 profile for a Drug Substance"
}, {
"name": "GENC and ISO 3166 Intersection",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-genc-and-iso-intersect"
},
"description": "The 3 letter country codes used in GENC and ISO have significant overlap: only the country codes in ISO 3166 that have an equivalent code in GENC may be used"
}, {
"name": "Graphic Reference",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-graphic-reference"
},
"description": "A Document Reference to any attachment tha contains a graphical representation"
}, {
"name": "Graphical File Types",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-graphical-file-types"
},
"description": "The acceptable file types that can be used in graphical files"
}, {
"name": "Hierarchical Level",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-hierarchical-level-extension"
},
"description": "Numeric level in the hierarchical value-set. As an example, this extension is used to distinguished between Test Category | Test Subcategory in Quality Specifications. Test Category is level 1 and Test Subcategory is level two. A constraint enforces values greater than zero."
}, {
"name": "Impurity Classification Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-impurity-classification-terminology"
},
"description": "Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Ingredient Location Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-product-part-ingredient-physical-location"
},
"description": "A category of terminology used to qualify the information pertaining to the location of an ingredient within a product in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Literal Coded Reference",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/literal-codeable-reference"
},
"description": "abstract profile to ensure the reference portion of a codeable reference is used, and that the reference is a literal reference to some resource in a bundle"
}, {
"name": "Literal Reference",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/literal-reference"
},
"description": "abstract profile to ensure the reference is always a literal reference. Used in conjuction with a rule set to ensure every reference is also bundled"
}, {
"name": "Manufactured Dose Form Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-manufactured-dose-form-terminology"
},
"description": "Terminology used to qualify the information pertaining to the manufactured dose form."
}, {
"name": "Manufactured Drug Product",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-product-part"
},
"description": "The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component."
}, {
"name": "Non-Percentage Units",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-non-percentage-units"
},
"description": "Units of Measure terminologies that do not represent percentages"
}, {
"name": "Organization-Site Identifier Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-org-identifier-type-terminology"
},
"description": "Terminology used to qualify the information pertaining to the sponsor or testing site unique identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Percentage Units",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-percentage-units"
},
"description": "Units of Measure terminologies that represent the concept of a percentage"
}, {
"name": "Pharmaceutical Dosage Form Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/spl-pharmaceutical-dosage-form-terminology"
},
"description": "Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the SPL documents."
}, {
"name": "Polymorphic Form",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-polymorphic-form"
},
"description": "Alternate structure present in the drug substance"
}, {
"name": "PQ-CMC-FDA NCIt Hieararchy Supplement",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"isExample": false,
"reference": {
"reference": "CodeSystem/cmc-hierarchy-supplement"
},
"description": "Provides hierarchical relationships for value sets as a CodeSystem supplement to the NCI Thesaurus (NCIt)"
}, {
"name": "PqAddress",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-cmc-address"
},
"description": "pq-specific Constraints on the Address datatype dealing with US addresses."
}, {
"name": "PQCMC Attachment",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-attachment"
},
"description": "Any attached file in a submission is required to have a type, data, and a title"
}, {
"name": "PQCMC Name Part Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-name-part-terminology"
},
"description": "Terminology used to qualify the information pertaining to Name Part data in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Product Name Types Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/cmc-product-name-types-vs"
},
"description": "The type of the product name. Often the proprietary name is unknow at the time of submission."
}, {
"name": "Product Part Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-product-part-type"
},
"description": "A category of terminology used to qualify the information pertaining to the product part type in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Quality Benchmark Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-quality-benchmark-terminology"
},
"description": "Terminology used to qualify the information pertaining to quality benchmarks in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Quality Specification",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-quality-specification"
},
"description": "A quality specification is for a drug product or drug substance (excipient, API or raw material)."
}, {
"name": "Release Mechanism Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-release-mechanism"
},
"description": "A category of terminology used to qualify the information pertaining to release mechanism in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Release Profile Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-release-profile"
},
"description": "A category of terminology used to qualify the information pertaining to release profile in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Representation Types",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-representation-types"
},
"description": "The different types of representations (graphical, structure/file and structure/text)"
}, {
"name": "Source Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-source-type-terminology"
},
"description": "Terminology used to qualify the information pertaining to source types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Specification Section Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/cmc-specification-types-vs"
},
"description": "Local value set of all codes in Specification Type codes"
}, {
"name": "Specification Status",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-specification-status-extension"
},
"description": "A classification of the regulatory status of the specification."
}, {
"name": "Specification Status Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-specification-status-terminology"
},
"description": "Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Specification Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-specification-type-terminology"
},
"description": "Terminology used to qualify the information pertaining to specification types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Strength Extension",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/strength-extension"
},
"description": "Strength Type (for API)"
}, {
"name": "Strength Type Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-strength-type-terminology"
},
"description": "Terminology used to qualify the information pertaining to strength types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Structure Data",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-structure-data"
},
"description": "Any attached file that contains structure data (e.g. SDFiles, MolFiles, INCHI)"
}, {
"name": "Structure Data Reference",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-structure-reference"
},
"description": "A Document Reference to any attachment that contains structure data"
}, {
"name": "Structure Data Types",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-structure-data-types"
},
"description": "The acceptable file types that can be used in Structure Data Files (MOL,SDF,INCHI,etc)"
}, {
"name": "Substance Classification",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/substance-classification"
},
"description": "Substance classes"
}, {
"name": "Substance General Information",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-drug-substance-nomenclature-structure"
},
"description": "Substance General Information containing Drug Substance (Active Ingredient) nomenclature (3.2.S.1.1) and Substance Structure (3.2.S.1.2) profile."
}, {
"name": "Substance Name Type",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-substance-name-type"
},
"description": "A category of terminology used to quality the information pertaining to the type of substance name in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Target Range",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-target-range"
},
"description": "The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator"
}, {
"name": "Test Category Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-test-category-terminology"
},
"description": "Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Test Method Origin Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-test-method-origin-terminology"
},
"description": "Terminology used to qualify the information pertaining to test method origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Test Usage Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-test-usage-terminology"
},
"description": "Terminology used to qualify the information pertaining to test usage in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Text Only Codeable Concept",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:complex-type:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/codeable-concept-text-only"
},
"description": "abstract profile for the common scenario where only the text field is used and is required. Doesn't stop the coding portion from being used but it will not be parsed"
}, {
"name": "Units Of Measure",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-units-of-measure"
},
"description": "Terminology used to qualify the information pertaining to units of measure in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.\nNote: Includes SPL Unit of Presentation Terminology"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
"valueCode": "hl7.fhir.uv.tools.r5#0.3.0"
} ],
"parameter": [ {
"code": {
"code": "copyrightyear",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "2021+"
}, {
"code": {
"code": "releaselabel",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "STU1"
}, {
"code": {
"code": "releaselabel",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "excludettl",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "excludemap",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-wg",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "jira-code",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "pq-cmc"
}, {
"code": {
"code": "auto-oid-root",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "2.16.840.1.113883.4.642.40.36"
}, {
"code": {
"code": "special-url",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl - https://www.uniprot.org - urn:oid:1.3.6.1.4.1.5193 - http://unitsofmeasure.org - urn:oid:1.3.6.1.4.1.519.1 - urn:oid:2.16.840.1.113883.4.82 - https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishments-current-registration-site - urn:ietf:rfc:3986"
}, {
"code": {
"code": "path-history",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://hl7.org/fhir/us/pq-cmc-fda/history.html"
}, {
"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"
}, {
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"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
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"value": "output"
}, {
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},
"value": "input-cache/txcache"
}, {
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"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "input/ignoreWarnings.txt"
}, {
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},
"value": "template-page.html"
}, {
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"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "template-page-md.html"
}, {
"code": {
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},
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}, {
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"system": "urn:iso:std:iso:3166",
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} ],
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"title": "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA",
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}