{
"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": "eCTD32P10.html",
"title": "Description and Composition of the Drug Product (3.2.P.1)",
"sourceUrl": "eCTD32P10.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": "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": "278736ef-2ddf-49e4-895c-3a9f34db36cf",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/278736ef-2ddf-49e4-895c-3a9f34db36cf"
},
"description": "The Excipient Raw representing Cochineal"
}, {
"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": "A DrugProductContainerClosure",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drugproduct-container-closure" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
} ],
"isExample": true,
"reference": {
"reference": "MedicinalProductDefinition/77ad6922-9c59-43d1-93cb-29d063cc2e8c"
},
"description": "An example of section 3.2.P.1.2 for a multilayer product"
}, {
"name": "A DrugProductDescription for a multilayer product",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-description" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
} ],
"isExample": true,
"reference": {
"reference": "MedicinalProductDefinition/5772a6f2-cde1-4903-bfcf-1639340205cc"
},
"description": "An example of section 3.2.P.1.1"
}, {
"name": "A FinishedProduct profile based on ManufacturedItemDefinition",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-part" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ManufacturedItemDefinition"
} ],
"isExample": true,
"reference": {
"reference": "ManufacturedItemDefinition/a8316fc9-8ca8-4115-81c1-9f8f84c99149"
},
"description": "An example of section 3.2.P.1.3 for a multilayer product"
}, {
"name": "A quality specification is for a drug product",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"isExample": true,
"reference": {
"reference": "PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7"
},
"description": "A quality specification is for a Drug Product"
}, {
"name": "A quality specification is for a drug substance",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"isExample": true,
"reference": {
"reference": "PlanDefinition/cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"
},
"description": "A quality specification is for an API"
}, {
"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"
}, {
"name": "Base64 Document Reference - L-thyroxine-3D-structure-CT1000583834.sdf",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-document-reference" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
} ],
"isExample": true,
"reference": {
"reference": "DocumentReference/22bd989e-8056-494f-9bc1-195d13428179"
},
"description": "An attached SDfile. The ASCII file content is attached in base64."
}, {
"name": "Base64 Document Reference - Levothyroid.png",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-document-reference" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
} ],
"isExample": true,
"reference": {
"reference": "DocumentReference/d94ad7ac-b935-432f-bc68-312b6b8dcca7"
},
"description": "Base 64 Document - png file"
}, {
"name": "Base64 Document Reference - Monosodium_D-thyroxine_hydrate.png",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-document-reference" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
} ],
"isExample": true,
"reference": {
"reference": "DocumentReference/0382d6b1-b656-4e9a-b5c8-9110c4d3f6b3"
},
"description": "Monosodium D-thyroxine hydrate.png"
}, {
"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": "Carrageenan specification Example",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"isExample": true,
"reference": {
"reference": "PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e"
},
"description": "Example raw material (Carrageenan) specification for CTD 3.2.S.2.3. Raw matrials and Excipients share the same profile but are in different bundles."
}, {
"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": "Citric acid specification Example",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"isExample": true,
"reference": {
"reference": "PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b"
},
"description": "Example raw material (Citric acid) specification for CTD 3.2.S.2.3"
}, {
"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": "Cochineal specification Composition Example",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"
},
"description": "Composition SP4151 implementing eCTD 3.2.P.4.0"
}, {
"name": "Cochineal specification Example",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"isExample": true,
"reference": {
"reference": "PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e"
},
"description": "Quality Specification for Cochineal"
}, {
"name": "Code System PQCMC Comp Section Types",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"isExample": false,
"reference": {
"reference": "CodeSystem/pqcmc-comp-section-types"
},
"description": "Classification of a section of a PQ/CMC composition/document generally based on eCTD Module 3 section numbering for product and substance. A composition can have many section codes. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems)."
}, {
"name": "Code System PQCMC Product Characteristic",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-product-characteristic"
},
"description": "Product Characteristic for the characteristic element in ManufacturedItemDefinition for product composition."
}, {
"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": "Composition ingredient substance indentifying information - acetaminophen",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/fc878c4f-a98c-427c-816b-e03ccdf0e712"
},
"description": "An API used in two layer table example."
}, {
"name": "Composition ingredient substance indentifying information - aspirin",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/2d70d504-8cc6-4282-81d4-b20b0a98b78b"
},
"description": "API used in two layer table example"
}, {
"name": "Composition ingredient substance indentifying information - Maize starch",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/393a14e7-3edc-4373-bbe5-9e569d504a1c"
},
"description": "An excipient in the two layer tablet"
}, {
"name": "Conformance to Criteria Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-conformance-to-criteria-terminology"
},
"description": "Terminology used to qualify the information pertaining to conformance to criteria in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"name": "Container Closure",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-container-closure-extension"
},
"description": "The packaging information including a brief description of the components, the assembled packaging system and any precautions needed to ensure the protection and preservation of the drug substance or drug product during their use in the clinical trials."
}, {
"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": "Content Percent",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/content-percent"
},
"description": "constituent content percent"
}, {
"name": "Document Reference Attachment",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-document-reference"
},
"description": "A profile that represents the document or diagram in base64."
}, {
"name": "Drug Manufacturing Site - Vandechemie",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/e165f057-5eed-4e64-8328-4438fc88fb1b"
},
"description": "Example of Manufacturing site using the MfgTestSiteOrganization profile - Vandechemie"
}, {
"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 Container Closure",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-drugproduct-container-closure"
},
"description": "Description and coding of the container closure system. Profile of Drug Product profile."
}, {
"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 for specification",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-product" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "MedicinalProductDefinition"
} ],
"isExample": true,
"reference": {
"reference": "MedicinalProductDefinition/89676a69-1fe7-422c-ab00-92abe4ef6ea9"
},
"description": "Includes the identifier of the drug product"
}, {
"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 Nomenclature and Structure",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-nomenclature-structure" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/21b6b724-507e-4cf4-a462-93334b98d166"
},
"description": "LEVOTHYROXINE SODIUM ANHYDROUS"
}, {
"name": "DrugProductComponent example for an excipient - Maize starch",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
} ],
"isExample": true,
"reference": {
"reference": "Ingredient/d01421cc-6488-468b-a676-d3e7281875e2"
},
"description": "Strength is captured for all excipients"
}, {
"name": "East-West Manufacturing",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/e875ef93-a730-4c44-bead-53663ae7f501"
},
"description": "Manufacture of Chemicals"
}, {
"name": "eCTD Composition for 3.2.S.1",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s10" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/260f5aa3-23d2-4999-8e5f-70f247390ee5"
},
"description": "Composistion containing eCTD Substance General Information"
}, {
"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 Drug Substance Specification Composition SP4151",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/55d92f43-e328-4011-bbcf-744e3afd954f"
},
"description": "Composition SP4151 implementing eCTD 3.2.S.4.1."
}, {
"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 Product Specification Composition SP4151",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/d332acdf-4874-407b-9950-528f14c6bea2"
},
"description": "Composition SP4151 implementing eCTD 3.2.P.5.1."
}, {
"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 for bindings that require a value set instead of the code system."
}, {
"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 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": "EctdComposition32P10 for 2 layer tablet",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p10" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/5dfbbf17-05c0-441d-af66-7a66072f4ae4"
},
"description": "eCTD Product Description and Composition for the two layer tablet example"
}, {
"name": "Example Composition for CTD 3.2.S.2.3",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Composition"
} ],
"isExample": true,
"reference": {
"reference": "Composition/5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"
},
"description": "This composition contains one section with reference to each raw material specification for the drug substance."
}, {
"name": "Example of a Supplier Organization",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
},
"description": "This example if for a Supplier Organization"
}, {
"name": "Example of MfgTestSiteOrganization profile on Organization",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9"
},
"description": "A profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances."
}, {
"name": "Example RoutineSubstanceDefinition - IBUPROFEN",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/580c28ac-1a2c-49fa-9be3-de997da5edcf"
},
"description": "Provides sufficient information to identify a drug substance"
}, {
"name": "Example RoutineSubstanceDefinition for Asprin",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/cd84a8b5-4e96-551c-15c6-c97c943eb38a"
},
"description": "Identification of the Drug Substance of the raw materials whose specifications are"
}, {
"name": "Example SubstanceDefinition for anhydrous citric acid",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/fd84a8b5-9e96-451c-a5c6-097c943eb38a"
},
"description": "Identification of the subject of the specification. It is commonly used in the pharmaceutical industry as a stabilizer and preservative."
}, {
"name": "Example SubstanceDefinition for Carrageenan",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/0efb1188-04f0-44ba-bfe7-ca6169ca8703"
},
"description": "Identification of the subject of the specification which is a sourced plant based raw materials. It contains the sourceMaterial backbone elements."
}, {
"name": "Example SubstanceDefinition for water",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/d3a11b25-e160-4688-b807-6383364096fd"
},
"description": "Identification of the subject of the specification"
}, {
"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.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": "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": "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"
}, {
"name": "Hierarchical Test Category Codes",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"isExample": false,
"reference": {
"reference": "CodeSystem/pqcmc-test-category-codes"
},
"description": "Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems). The hierarchy will presist in the IG."
}, {
"name": "IngredComponentSubstance example showing the use of the sourceMaterial backbone element",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/496f83ad-2365-4b12-8672-a349d99f7d67"
},
"description": "ComponentSubstance example showing the use use of the sourceMaterial backbone element"
}, {
"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": "Interpretation Code",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-interpretation-code-extension"
},
"description": "A code that describes how to relate the given value to an acceptance value."
}, {
"name": "Interpretation Code Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-interpretation-code-terminology"
},
"description": "Terminology used to qualify the information pertaining to numeric interpretation codes, Weight Operator codes and Amount Operator code in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"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": "Manufacturing and/or Test Site Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/mfg-test-site-organization"
},
"description": "A profile for the data elements required to identify an organization that manufactures, processes or tests drug products or substances."
}, {
"name": "Manufacturing Site (J. Jones Research)",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/4b565cf3-5353-48af-8cd6-5ccf4e9fd579"
},
"description": "Manufacturing site instance of an Organization Example. There will be a type code in future"
}, {
"name": "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": "Optional Denominator",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/optional-denominator"
},
"description": "The constituent optional denominator is used then the unit is other than 1 per product part."
}, {
"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": "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": "Polymorphic Form Example",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubstanceDefinition"
} ],
"isExample": true,
"reference": {
"reference": "SubstanceDefinition/832f22b4-6f0c-41f8-9b7d-f26f55e9973c"
},
"description": "Polymorphic Form - DextroThyroxine"
}, {
"name": "PQ-CMC-FDA Temporary Codes",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"isExample": false,
"reference": {
"reference": "CodeSystem/cmc-ncit-dummy"
},
"description": "Codes are temporarily defined as part of the PQ-CMC-FDA implementation guide. Some but not all are defined in NCIt. When all codes are in NCIt, they will migrate to the HL7 Terminology (THO). Note: Codes that exist in CNIt at time of ballot begin with 'C'."
}, {
"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": "Product Name Types Code Types",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"isExample": false,
"reference": {
"reference": "CodeSystem/cmc-product-name-types"
},
"description": "Indicates patent or trademark status. Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems"
}, {
"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": "Local value set of all codes in the Code system."
}, {
"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": "Profile IG Version",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-ig-version"
},
"description": "The IG version number of the bundle profile to which the instance conforms. Additionally, all the profiles of the resources in the bundle must conform to this version."
}, {
"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": "Relationship Types Codes",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
} ],
"isExample": false,
"reference": {
"reference": "CodeSystem/cmc-relationship-types"
},
"description": "Local value set of all codes in the Relationship Types code system.Codes temporarily defined as part of the PQ-CMC-FDA implementation guide. These will eventually migrate into an officially maintained terminology (likely either NCIt or HL7's UTG code systems"
}, {
"name": "Relationship Types Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/cmc-relationship-types-vs"
},
"description": "Local value set of all codes in Relationship Types codes"
}, {
"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": "Routine Drug Product",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pqcmc-routine-drug-product"
},
"description": "Includes the identifying information of the drug product. Profile of Drug Product profile."
}, {
"name": "Routine Drug Substance",
"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 Drug Substance profile."
}, {
"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 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",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-specification-type-extension"
},
"description": "A classification of specification related to the kind of the entity it is referencing."
}, {
"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": "Sponsor of API",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/b69435a0-45c6-4d44-9fde-b354e17408d7"
},
"description": "SponsorOrganization - Large Life"
}, {
"name": "Sponsor Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/cmc-sponsor-organization"
},
"description": "A profile for the data elements required to identify the sponsor of the drug products or substances."
}, {
"name": "SponsorOrganization - Wunderwerke",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/4f3e9af1-306b-4fad-bf04-7881400b266a"
},
"description": "A company sponsor of a drug application"
}, {
"name": "SponsorOrganization J. Jones Research",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/49438799-e286-432c-b8d8-68ac77e7f519"
},
"description": "Example of a Sponsor type of Organization"
}, {
"name": "Strength Extension",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/strength-extension"
},
"description": "Values required in Ingredient.substance.strength"
}, {
"name": "Strength info for the Active Ingredient",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
} ],
"isExample": true,
"reference": {
"reference": "Ingredient/fc09842a-8f71-48f2-9f9f-ff2441b2eb6f"
},
"description": "one of the active ingredients in the two layer table example - aspirin"
}, {
"name": "Strength information - Grape skin extract",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
} ],
"isExample": true,
"reference": {
"reference": "Ingredient/3791c4ce-2b43-4d7b-b195-0e5f88f28dab"
},
"description": "Example of a DrugProductComponent for an Inactive Ingredient"
}, {
"name": "Strength information for the Active Ingredient - acetaminophen",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Ingredient"
} ],
"isExample": true,
"reference": {
"reference": "Ingredient/7f10a35e-228d-42db-8918-6ccada78454d"
},
"description": "An active ingredient in the two layer table example - acetaminophen"
}, {
"name": "Strength Operator Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-strength-operator-terminology"
},
"description": "Terminology used to qualify the information pertaining to strength operators in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."
}, {
"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": "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 containting Drug Substance (Active Ingredient) nomenclature (2.3.S.1.1) and Substance Structure (2.3.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": "Supplier Organization",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource:abstract"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/supplier-organization"
},
"description": "A profile for the data elements required to identify an organization that supplies drug products or substances."
}, {
"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 Order | Stage Sequence Order",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:extension"
} ],
"isExample": false,
"reference": {
"reference": "StructureDefinition/pq-order-extension"
},
"description": "The sequential number assigned to each Test or Stage to specify the order of display on the Quality Specification."
}, {
"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": "Units Of Measure Terminology",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "ValueSet"
} ],
"isExample": false,
"reference": {
"reference": "ValueSet/pqcmc-units-of-measure-terminology"
},
"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"
}, {
"name": "Vidinaid",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
} ],
"isExample": true,
"reference": {
"reference": "Organization/e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
},
"description": "Manufacturing site (Vidinaid) instance with second address line"
}, {
"name": "Water Specification Example",
"profile": [ "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification" ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "PlanDefinition"
} ],
"isExample": true,
"reference": {
"reference": "PlanDefinition/5819b223-d3d2-419f-b617-b3a9a3625b89"
},
"description": "Example raw material (water) specification for CTD 3.2.S.2.3"
} ],
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/ig-internal-dependency",
"valueCode": "hl7.fhir.uv.tools#0.1.0"
} ],
"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": "STU 1-ballot"
}, {
"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"
}, {
"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": "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"
}, {
"code": {
"code": "apply-context",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-copyright",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-jurisdiction",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-license",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-publisher",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "apply-version",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "active-tables",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "fmm-definition",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "http://hl7.org/fhir/versions.html#maturity"
}, {
"code": {
"code": "propagate-status",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "excludelogbinaryformat",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
}, {
"code": {
"code": "tabbed-snapshots",
"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters"
},
"value": "true"
} ]
},
"date": "2024-04-08T17:51:06+00:00",
"publisher": "HL7 International / Biomedical Research and Regulation",
"fhirVersion": [ "5.0.0" ],
"license": "CC0-1.0",
"jurisdiction": [ {
"coding": [ {
"code": "US",
"system": "urn:iso:std:iso:3166",
"display": "United States of America"
} ]
} ],
"dependsOn": [ {
"id": "hl7ext",
"uri": "http://hl7.org/fhir/extensions/ImplementationGuide/hl7.fhir.uv.extensions",
"version": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/tools/StructureDefinition/implementationguide-dependency-comment",
"valueMarkdown": "Automatically added as a dependency - all IGs depend on the HL7 Extension Pack"
} ],
"packageId": "hl7.fhir.uv.extensions.r5"
}, {
"id": "hl7_terminology",
"uri": "http://terminology.hl7.org/ImplementationGuide/hl7.terminology",
"version": "5.5.0",
"packageId": "hl7.terminology"
} ],
"name": "FHIR_pqcmc_fda",
"type": null,
"experimental": null,
"resourceType": "ImplementationGuide",
"title": "Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA",
"package_version": "1.0.0-ballot",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode": "brr"
} ],
"status": "active",
"id": "e536a506-7ef6-42cf-9750-ef75ad03c0c6",
"kind": null,
"url": "http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda",
"identifier": [ {
"value": "urn:oid:2.16.840.1.113883.4.642.40.36",
"system": "urn:ietf:rfc:3986"
} ],
"version": "1.0.0-ballot",
"packageId": "hl7.fhir.us.pq-cmc-fda",
"contact": [ {
"name": "HL7 International / Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
}, {
"value": "brr@lists.HL7.org",
"system": "email"
} ]
} ]
}