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FHIR-us-pq-cmc-fda.xml
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FHIR-us-pq-cmc-fda.xml
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<?xml version="1.0" encoding="UTF-8"?>
<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/us/pq-cmc-fda/2024May" ciUrl="https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda" defaultVersion="1.0.0-ballot" defaultWorkgroup="brr" gitUrl="https://github.com/HL7/FHIR-us-pq-cmc" url="http://hl7.org/fhir/us/pq-cmc-fda">
<version code="current" url="https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda"/>
<version code="1.0.0-ballot" url="http://hl7.org/fhir/us/pq-cmc-fda/2024May"/>
<artifactPageExtension value="-definitions"/>
<artifactPageExtension value="-examples"/>
<artifactPageExtension value="-mappings"/>
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<artifact id="MedicinalProductDefinition/5772a6f2-cde1-4903-bfcf-1639340205cc" key="MedicinalProductDefinition-5772a6f2-cde1-4903-bfcf-1639340205cc" name="A DrugProductDescription for a multilayer product"/>
<artifact id="ManufacturedItemDefinition/a8316fc9-8ca8-4115-81c1-9f8f84c99149" key="ManufacturedItemDefinition-a8316fc9-8ca8-4115-81c1-9f8f84c99149" name="A FinishedProduct profile based on ManufacturedItemDefinition"/>
<artifact id="PlanDefinition/aa514363-d43f-4052-b44e-b67aa4d6dee7" key="PlanDefinition-aa514363-d43f-4052-b44e-b67aa4d6dee7" name="A quality specification is for a drug product"/>
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<artifact id="StructureDefinition/pq-additional-info-extension" key="StructureDefinition-pq-additional-info-extension" name="Additional Information"/>
<artifact id="DocumentReference/22bd989e-8056-494f-9bc1-195d13428179" key="DocumentReference-22bd989e-8056-494f-9bc1-195d13428179" name="Base64 Document Reference - L-thyroxine-3D-structure-CT1000583834.sdf"/>
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<artifact id="StructureDefinition/cmc-ectd-document-32p10" key="StructureDefinition-cmc-ectd-document-32p10" name="CMC eCTD 32P10 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-32s10" key="StructureDefinition-cmc-ectd-document-32s10" name="CMC eCTD 32S10 Document"/>
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<artifact id="ValueSet/pqcmc-chemical-structure-datafile-type-terminology" key="ValueSet-pqcmc-chemical-structure-datafile-type-terminology" name="Chemical Structure Data File Type Terminology"/>
<artifact id="PlanDefinition/a2cba634-a481-4b07-9bd4-62c7ada31e1b" key="PlanDefinition-a2cba634-a481-4b07-9bd4-62c7ada31e1b" name="Citric acid specification Example"/>
<artifact id="ValueSet/pqcmc-closure-type-terminology" key="ValueSet-pqcmc-closure-type-terminology" name="Closure Type Terminology"/>
<artifact id="ValueSet/pqcmc-coating-purpose" key="ValueSet-pqcmc-coating-purpose" name="Coating Purpose Terminology"/>
<artifact id="Composition/4bd1ed57-852b-42be-a9b0-355f8a2aa7d4" key="Composition-4bd1ed57-852b-42be-a9b0-355f8a2aa7d4" name="Cochineal specification Composition Example"/>
<artifact id="PlanDefinition/37bf5cc0-33bf-478b-b84e-ccb35143ef6e" key="PlanDefinition-37bf5cc0-33bf-478b-b84e-ccb35143ef6e" name="Cochineal specification Example"/>
<artifact id="CodeSystem/pqcmc-comp-section-types" key="CodeSystem-pqcmc-comp-section-types" name="Code System PQCMC Comp Section Types"/>
<artifact id="ValueSet/pqcmc-product-characteristic" key="ValueSet-pqcmc-product-characteristic" name="Code System PQCMC Product Characteristic"/>
<artifact id="StructureDefinition/pqcmc-component-substance" key="StructureDefinition-pqcmc-component-substance" name="Component Substance"/>
<artifact id="SubstanceDefinition/393a14e7-3edc-4373-bbe5-9e569d504a1c" key="SubstanceDefinition-393a14e7-3edc-4373-bbe5-9e569d504a1c" name="Composition ingredient substance indentifying information - Maize starch"/>
<artifact id="SubstanceDefinition/fc878c4f-a98c-427c-816b-e03ccdf0e712" key="SubstanceDefinition-fc878c4f-a98c-427c-816b-e03ccdf0e712" name="Composition ingredient substance indentifying information - acetaminophen"/>
<artifact id="SubstanceDefinition/2d70d504-8cc6-4282-81d4-b20b0a98b78b" key="SubstanceDefinition-2d70d504-8cc6-4282-81d4-b20b0a98b78b" name="Composition ingredient substance indentifying information - aspirin"/>
<artifact id="ValueSet/pqcmc-conformance-to-criteria-terminology" key="ValueSet-pqcmc-conformance-to-criteria-terminology" name="Conformance to Criteria Terminology"/>
<artifact id="StructureDefinition/pq-container-closure-extension" key="StructureDefinition-pq-container-closure-extension" name="Container Closure"/>
<artifact id="ValueSet/pqcmc-container-type-terminology" key="ValueSet-pqcmc-container-type-terminology" name="Container Type Terminology"/>
<artifact id="StructureDefinition/content-percent" key="StructureDefinition-content-percent" name="Content Percent"/>
<artifact id="StructureDefinition/cmc-document-reference" key="StructureDefinition-cmc-document-reference" name="Document Reference Attachment"/>
<artifact id="Organization/e165f057-5eed-4e64-8328-4438fc88fb1b" key="Organization-e165f057-5eed-4e64-8328-4438fc88fb1b" name="Drug Manufacturing Site - Vandechemie"/>
<artifact id="StructureDefinition/pqcmc-component" key="StructureDefinition-pqcmc-component" name="Drug Product Component"/>
<artifact id="ValueSet/pqcmc-drug-product-component-function-category-terminology" key="ValueSet-pqcmc-drug-product-component-function-category-terminology" name="Drug Product Component Function Category Terminology"/>
<artifact id="StructureDefinition/pqcmc-drug-product-description" key="StructureDefinition-pqcmc-drug-product-description" name="Drug Product Description"/>
<artifact id="ValueSet/spl-drug-route-of-administration-terminology" key="ValueSet-spl-drug-route-of-administration-terminology" name="Drug Route Of Administration Terminology"/>
<artifact id="SubstanceDefinition/21b6b724-507e-4cf4-a462-93334b98d166" key="SubstanceDefinition-21b6b724-507e-4cf4-a462-93334b98d166" name="Drug Substance Nomenclature and Structure"/>
<artifact id="Ingredient/d01421cc-6488-468b-a676-d3e7281875e2" key="Ingredient-d01421cc-6488-468b-a676-d3e7281875e2" name="DrugProductComponent example for an excipient - Maize starch"/>
<artifact id="Organization/e875ef93-a730-4c44-bead-53663ae7f501" key="Organization-e875ef93-a730-4c44-bead-53663ae7f501" name="East-West Manufacturing"/>
<artifact id="Composition/5dfbbf17-05c0-441d-af66-7a66072f4ae4" key="Composition-5dfbbf17-05c0-441d-af66-7a66072f4ae4" name="EctdComposition32P10 for 2 layer tablet"/>
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<artifact id="SubstanceDefinition/580c28ac-1a2c-49fa-9be3-de997da5edcf" key="SubstanceDefinition-580c28ac-1a2c-49fa-9be3-de997da5edcf" name="Example RoutineSubstanceDefinition - IBUPROFEN"/>
<artifact id="SubstanceDefinition/cd84a8b5-4e96-551c-15c6-c97c943eb38a" key="SubstanceDefinition-cd84a8b5-4e96-551c-15c6-c97c943eb38a" name="Example RoutineSubstanceDefinition for Asprin"/>
<artifact id="SubstanceDefinition/0efb1188-04f0-44ba-bfe7-ca6169ca8703" key="SubstanceDefinition-0efb1188-04f0-44ba-bfe7-ca6169ca8703" name="Example SubstanceDefinition for Carrageenan"/>
<artifact id="SubstanceDefinition/fd84a8b5-9e96-451c-a5c6-097c943eb38a" key="SubstanceDefinition-fd84a8b5-9e96-451c-a5c6-097c943eb38a" name="Example SubstanceDefinition for anhydrous citric acid"/>
<artifact id="SubstanceDefinition/d3a11b25-e160-4688-b807-6383364096fd" key="SubstanceDefinition-d3a11b25-e160-4688-b807-6383364096fd" name="Example SubstanceDefinition for water"/>
<artifact id="Organization/8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9" key="Organization-8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9" name="Example of MfgTestSiteOrganization profile on Organization"/>
<artifact id="Organization/d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" key="Organization-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" name="Example of a Supplier Organization"/>
<artifact id="StructureDefinition/pqcmc-excipient" key="StructureDefinition-pqcmc-excipient" name="Excipient Drug Substance"/>
<artifact id="ValueSet/pqcmc-excipient-function-terminology" key="ValueSet-pqcmc-excipient-function-terminology" name="Excipient Function Terminology"/>
<artifact id="Bundle/6004e36e-7df9-469d-9b29-8e9f9bd7e95f" key="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f" name="FHIR Document example of 3.2.P.4.1."/>
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<artifact id="StructureDefinition/pq-hierarchical-level-extension" key="StructureDefinition-pq-hierarchical-level-extension" name="Hierarchical Level"/>
<artifact id="CodeSystem/pqcmc-test-category-codes" key="CodeSystem-pqcmc-test-category-codes" name="Hierarchical Test Category Codes"/>
<artifact id="SubstanceDefinition/496f83ad-2365-4b12-8672-a349d99f7d67" key="SubstanceDefinition-496f83ad-2365-4b12-8672-a349d99f7d67" name="IngredComponentSubstance example showing the use of the sourceMaterial backbone element"/>
<artifact id="ValueSet/pqcmc-product-part-ingredient-physical-location" key="ValueSet-pqcmc-product-part-ingredient-physical-location" name="Ingredient Location Terminology"/>
<artifact id="StructureDefinition/pq-interpretation-code-extension" key="StructureDefinition-pq-interpretation-code-extension" name="Interpretation Code"/>
<artifact id="ValueSet/pqcmc-interpretation-code-terminology" key="ValueSet-pqcmc-interpretation-code-terminology" name="Interpretation Code Terminology"/>
<artifact id="ValueSet/pqcmc-manufactured-dose-form-terminology" key="ValueSet-pqcmc-manufactured-dose-form-terminology" name="Manufactured Dose Form Terminology"/>
<artifact id="StructureDefinition/pqcmc-product-part" key="StructureDefinition-pqcmc-product-part" name="Manufactured Drug Product"/>
<artifact id="Organization/4b565cf3-5353-48af-8cd6-5ccf4e9fd579" key="Organization-4b565cf3-5353-48af-8cd6-5ccf4e9fd579" name="Manufacturing Site (J. Jones Research)"/>
<artifact id="ValueSet/pqcmc-name-part-terminology" key="ValueSet-pqcmc-name-part-terminology" name="Name Part Terminology"/>
<artifact id="StructureDefinition/optional-denominator" key="StructureDefinition-optional-denominator" name="Optional Denominator"/>
<artifact id="ValueSet/pqcmc-org-identifier-type-terminology" key="ValueSet-pqcmc-org-identifier-type-terminology" name="Organization-Site Identifier Terminology"/>
<artifact id="CodeSystem/cmc-ncit-dummy" key="CodeSystem-cmc-ncit-dummy" name="PQ-CMC-FDA Temporary Codes"/>
<artifact id="ValueSet/spl-pharmaceutical-dosage-form-terminology" key="ValueSet-spl-pharmaceutical-dosage-form-terminology" name="Pharmaceutical Dosage Form Terminology"/>
<artifact id="StructureDefinition/pqcmc-polymorphic-form" key="StructureDefinition-pqcmc-polymorphic-form" name="Polymorphic Form"/>
<artifact id="SubstanceDefinition/832f22b4-6f0c-41f8-9b7d-f26f55e9973c" key="SubstanceDefinition-832f22b4-6f0c-41f8-9b7d-f26f55e9973c" name="Polymorphic Form Example"/>
<artifact id="StructureDefinition/pq-cmc-address" key="StructureDefinition-pq-cmc-address" name="PqAddress"/>
<artifact id="CodeSystem/cmc-product-name-types" key="CodeSystem-cmc-product-name-types" name="Product Name Types Code Types"/>
<artifact id="ValueSet/cmc-product-name-types-vs" key="ValueSet-cmc-product-name-types-vs" name="Product Name Types Terminology"/>
<artifact id="ValueSet/pqcmc-product-part-type" key="ValueSet-pqcmc-product-part-type" name="Product Part Type Terminology"/>
<artifact id="StructureDefinition/pq-ig-version" key="StructureDefinition-pq-ig-version" name="Profile IG Version"/>
<artifact id="ValueSet/pqcmc-quality-benchmark-terminology" key="ValueSet-pqcmc-quality-benchmark-terminology" name="Quality Benchmark Terminology"/>
<artifact id="StructureDefinition/pqcmc-quality-specification" key="StructureDefinition-pqcmc-quality-specification" name="Quality Specification"/>
<artifact id="CodeSystem/cmc-relationship-types" key="CodeSystem-cmc-relationship-types" name="Relationship Types Codes"/>
<artifact id="ValueSet/cmc-relationship-types-vs" key="ValueSet-cmc-relationship-types-vs" name="Relationship Types Terminology"/>
<artifact id="ValueSet/pqcmc-release-mechanism" key="ValueSet-pqcmc-release-mechanism" name="Release Mechanism Terminology"/>
<artifact id="ValueSet/pqcmc-release-profile" key="ValueSet-pqcmc-release-profile" name="Release Profile Terminology"/>
<artifact id="StructureDefinition/pqcmc-routine-drug-product" key="StructureDefinition-pqcmc-routine-drug-product" name="Routine Drug Product"/>
<artifact id="StructureDefinition/pqcmc-routine-drug-substance" key="StructureDefinition-pqcmc-routine-drug-substance" name="Routine Drug Substance"/>
<artifact id="ValueSet/pqcmc-source-type-terminology" key="ValueSet-pqcmc-source-type-terminology" name="Source Type Terminology"/>
<artifact id="ValueSet/pqcmc-specification-status-terminology" key="ValueSet-pqcmc-specification-status-terminology" name="Specification Status Terminology"/>
<artifact id="StructureDefinition/pq-specification-type-extension" key="StructureDefinition-pq-specification-type-extension" name="Specification Type"/>
<artifact id="ValueSet/pqcmc-specification-type-terminology" key="ValueSet-pqcmc-specification-type-terminology" name="Specification Type Terminology"/>
<artifact id="StructureDefinition/cmc-sponsor-organization" key="StructureDefinition-cmc-sponsor-organization" name="Sponsor Organization"/>
<artifact id="Organization/b69435a0-45c6-4d44-9fde-b354e17408d7" key="Organization-b69435a0-45c6-4d44-9fde-b354e17408d7" name="Sponsor of API"/>
<artifact id="Organization/4f3e9af1-306b-4fad-bf04-7881400b266a" key="Organization-4f3e9af1-306b-4fad-bf04-7881400b266a" name="SponsorOrganization - Wunderwerke"/>
<artifact id="Organization/49438799-e286-432c-b8d8-68ac77e7f519" key="Organization-49438799-e286-432c-b8d8-68ac77e7f519" name="SponsorOrganization J. Jones Research"/>
<artifact id="StructureDefinition/strength-extension" key="StructureDefinition-strength-extension" name="Strength Extension"/>
<artifact id="ValueSet/pqcmc-strength-operator-terminology" key="ValueSet-pqcmc-strength-operator-terminology" name="Strength Operator Terminology"/>
<artifact id="ValueSet/pqcmc-strength-type-terminology" key="ValueSet-pqcmc-strength-type-terminology" name="Strength Type Terminology"/>
<artifact id="Ingredient/fc09842a-8f71-48f2-9f9f-ff2441b2eb6f" key="Ingredient-fc09842a-8f71-48f2-9f9f-ff2441b2eb6f" name="Strength info for the Active Ingredient"/>
<artifact id="Ingredient/3791c4ce-2b43-4d7b-b195-0e5f88f28dab" key="Ingredient-3791c4ce-2b43-4d7b-b195-0e5f88f28dab" name="Strength information - Grape skin extract"/>
<artifact id="Ingredient/7f10a35e-228d-42db-8918-6ccada78454d" key="Ingredient-7f10a35e-228d-42db-8918-6ccada78454d" name="Strength information for the Active Ingredient - acetaminophen"/>
<artifact id="ValueSet/substance-classification" key="ValueSet-substance-classification" name="Substance Classification"/>
<artifact id="StructureDefinition/pqcmc-drug-substance-nomenclature-structure" key="StructureDefinition-pqcmc-drug-substance-nomenclature-structure" name="Substance General Information"/>
<artifact id="ValueSet/pqcmc-substance-name-type" key="ValueSet-pqcmc-substance-name-type" name="Substance Name Type"/>
<artifact id="StructureDefinition/supplier-organization" key="StructureDefinition-supplier-organization" name="Supplier Organization"/>
<artifact id="ValueSet/pqcmc-test-category-terminology" key="ValueSet-pqcmc-test-category-terminology" name="Test Category Terminology"/>
<artifact id="ValueSet/pqcmc-test-method-origin-terminology" key="ValueSet-pqcmc-test-method-origin-terminology" name="Test Method Origin Terminology"/>
<artifact id="StructureDefinition/pq-order-extension" key="StructureDefinition-pq-order-extension" name="Test Order | Stage Sequence Order"/>
<artifact id="ValueSet/pqcmc-test-usage-terminology" key="ValueSet-pqcmc-test-usage-terminology" name="Test Usage Terminology"/>
<artifact id="Organization/e99bddfa-c1b5-435b-bbe8-24816b4e23e5" key="Organization-e99bddfa-c1b5-435b-bbe8-24816b4e23e5" name="Vidinaid"/>
<artifact id="PlanDefinition/5819b223-d3d2-419f-b617-b3a9a3625b89" key="PlanDefinition-5819b223-d3d2-419f-b617-b3a9a3625b89" name="Water Specification Example"/>
<artifact id="MedicinalProductDefinition/89676a69-1fe7-422c-ab00-92abe4ef6ea9" key="MedicinalProductDefinition-89676a69-1fe7-422c-ab00-92abe4ef6ea9" name="drug product for specification"/>
<artifact id="Composition/260f5aa3-23d2-4999-8e5f-70f247390ee5" key="Composition-260f5aa3-23d2-4999-8e5f-70f247390ee5" name="eCTD Composition for 3.2.S.1"/>
<artifact id="Bundle/7ce2088d-d281-4e2f-9a25-120a1f9805d1" key="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1" name="eCTD Document for 32S23"/>
<artifact id="Composition/55d92f43-e328-4011-bbcf-744e3afd954f" key="Composition-55d92f43-e328-4011-bbcf-744e3afd954f" name="eCTD Drug Substance Specification Composition SP4151"/>
<artifact id="StructureDefinition/ectd-composition-32p10" key="StructureDefinition-ectd-composition-32p10" name="eCTD Product Description and Composition"/>
<artifact id="Composition/d332acdf-4874-407b-9950-528f14c6bea2" key="Composition-d332acdf-4874-407b-9950-528f14c6bea2" name="eCTD Product Specification Composition SP4151"/>
<artifact id="StructureDefinition/ectd-composition-sp4151" key="StructureDefinition-ectd-composition-sp4151" name="eCTD Specification Composition"/>
<artifact id="StructureDefinition/ectd-composition-32s23" key="StructureDefinition-ectd-composition-32s23" name="eCTD Substance Control of Materials Composition"/>
<artifact id="StructureDefinition/ectd-composition-32s10" key="StructureDefinition-ectd-composition-32s10" name="eCTD Substance General Information"/>
<artifact id="ValueSet/cmc-comp-section-types-vs" key="ValueSet-cmc-comp-section-types-vs" name="eCTD sections Terminology"/>
<page key="NA" name="(NA)"/>
<page key="many" name="(many)"/>
<page key="artifacts" name="Artifact List"/>
<page key="change_notes" name="Change Notes"/>
<page key="eCTD32P10" name="Description and Composition of the Drug Product (3.2.P.1)"/>
<page key="downloads" name="Downloads"/>
<page key="eCTD32S10" name="General Information (3.2.S.1)"/>
<page key="instruction" name="General Instructions"/>
<page key="index" name="Home"/>
<page key="eCTDSP4151" name="Specification (3.2.S.4.1, 3.2.P.4 and 3.2.P.5.1)"/>
<page key="eCTD32S23" name="Substance Control of Materials (3.2.S.2.3)"/>
<page key="toc" name="Table of Contents"/>
</specification>