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STU2 ballot
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@chn100
chn100 authored Nov 27, 2024
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31 changes: 28 additions & 3 deletions xml/FHIR-us-pq-cmc.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" defaultWorkgroup="brr" gitUrl="https://github.com/HL7/FHIR-us-pq-cmc" url="http://hl7.org/fhir/us/pq-cmc-fda">
<specification xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" ballotUrl="http://hl7.org/fhir/us/pq-cmc-fda/STU2-ballot" ciUrl="https://build.fhir.org/ig/HL7/FHIR-us-pq-cmc-fda" defaultVersion="1.0.1-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" url="http://hl7.org/fhir/us/pq-cmc-fda/STU1"/>
<version code="1.0.0-ballot" url="http://hl7.org/fhir/us/pq-cmc-fda/2024May"/>
<version code="1.0.1-ballot" url="http://hl7.org/fhir/us/pq-cmc-fda/STU2-ballot"/>
<version code="1.0.0-ballot" deprecated="true" url="http://hl7.org/fhir/us/pq-cmc-fda/2024May"/>
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Expand All @@ -16,16 +18,22 @@
<artifact id="StructureDefinition/pq-additional-info-extension" key="StructureDefinition-pq-additional-info-extension" name="Additional Information"/>
<artifact id="StructureDefinition/pq-amount-ratio" key="StructureDefinition-pq-amount-ratio" name="Amount Ratio"/>
<artifact id="StructureDefinition/pqcmc-graphic-attachment" key="StructureDefinition-pqcmc-graphic-attachment" name="Analysis Graphic"/>
<artifact id="StructureDefinition/pqcmc-analytical-intstrument-data" key="StructureDefinition-pqcmc-analytical-intstrument-data" name="Analytical Instrument Data"/>
<artifact id="ValueSet/pqcmc-analytical-instrument-data-types" key="ValueSet-pqcmc-analytical-instrument-data-types" name="Analytical Instrument Data File Types"/>
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<artifact id="StructureDefinition/cmc-ectd-document-32s23" key="StructureDefinition-cmc-ectd-document-32s23" name="CMC eCTD 32S23 Document"/>
<artifact id="StructureDefinition/cmc-ectd-document-32s3" key="StructureDefinition-cmc-ectd-document-32s3" name="CMC eCTD 32S3 Document"/>
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<artifact id="ValueSet/capsule-classification-category" key="ValueSet-capsule-classification-category" name="Capsule Shell Classification Terminology"/>
Expand All @@ -51,19 +59,26 @@
<artifact deprecated="true" 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"/>
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<artifact id="StructureDefinition/pqcmc-dp-ingredient" key="StructureDefinition-pqcmc-dp-ingredient" name="Drug Product Batch Formula Ingredient"/>
<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"/>
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<artifact id="StructureDefinition/pqcmc-drug-product-handle" key="StructureDefinition-pqcmc-drug-product-handle" name="Drug Product Handle"/>
<artifact id="StructureDefinition/pqcmc-drug-product-with-impurities" key="StructureDefinition-pqcmc-drug-product-with-impurities" name="Drug Product Impurities"/>
<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="StructureDefinition/pqcmc-drug-substance-characterisation" key="StructureDefinition-pqcmc-drug-substance-characterisation" name="Drug Substance"/>
<artifact id="StructureDefinition/pqcmc-routine-drug-substance" key="StructureDefinition-pqcmc-routine-drug-substance" name="Drug Substance Handle"/>
<artifact id="StructureDefinition/pqcmc-drug-product-substance-impurity" key="StructureDefinition-pqcmc-drug-product-substance-impurity" name="Drug Substance Impurity"/>
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Expand All @@ -85,6 +100,7 @@
<artifact id="StructureDefinition/pq-hierarchical-level-extension" key="StructureDefinition-pq-hierarchical-level-extension" name="Hierarchical Level"/>
<artifact deprecated="true" id="CodeSystem/pqcmc-test-category-codes" key="CodeSystem-pqcmc-test-category-codes" name="Hierarchical Test Category Codes"/>
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Expand All @@ -108,6 +124,8 @@
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Expand Down Expand Up @@ -151,13 +169,17 @@
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<artifact id="ValueSet/cmc-comp-section-types-vs" key="ValueSet-cmc-comp-section-types-vs" name="eCTD sections Terminology"/>
Expand All @@ -171,7 +193,10 @@
<page key="eCTD32S10" name="General Information (3.2.S.1)"/>
<page key="instruction" name="General Instructions"/>
<page key="index" name="Home"/>
<page key="eCTD32P32" name="Product Batch Formula (3.2.P.3.2)"/>
<page key="eCTD32P55" name="Product Characterisation of Impurities (3.2.P.5.5)"/>
<page key="eCTDSP4151" name="Specification (3.2.S.4.1, 3.2.P.4 and 3.2.P.5.1)"/>
<page key="eCTD32S3" name="Substance Characterisation (3.2.S.3)"/>
<page key="eCTD32S23" name="Substance Control of Materials (3.2.S.2.3)"/>
<page key="toc" name="Table of Contents"/>
</specification>

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