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Update FHIR-us-pq-cmc.xml STU1 #1104

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18 changes: 4 additions & 14 deletions xml/FHIR-us-pq-cmc.xml
Original file line number Diff line number Diff line change
@@ -1,7 +1,7 @@
<?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/2024Jan" 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">
<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/2024Jan"/>
<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"/>
Expand Down Expand Up @@ -44,20 +44,16 @@
<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-drugproduct-container-closure" key="StructureDefinition-pqcmc-drugproduct-container-closure" name="Drug Product Container Closure"/>
<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 deprecated="true" id="CodeSystem/cmc-ema-dummy" key="CodeSystem-cmc-ema-dummy" name="Dummy EMA Codesystem"/>
<artifact deprecated="true" id="ValueSet/evmpd-substance-classification" key="ValueSet-evmpd-substance-classification" name="EVMPD Substance Classification"/>
<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"/>
<artifact id="Composition/5c0d341e-6e4f-457c-811d-cfaf3eb62ecd" key="Composition-5c0d341e-6e4f-457c-811d-cfaf3eb62ecd" name="Example Composition for CTD 3.2.S.2.3"/>
<artifact deprecated="true" id="SubstanceDefinition/5f66b17e-e3c0-4ee4-8106-59faa34d70f7" key="SubstanceDefinition-5f66b17e-e3c0-4ee4-8106-59faa34d70f7" name="Example RoutineSubstanceDefinition"/>
<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-d8242262-2187-4ea2-907f-b66752202b46" name="Example SubstanceDefinition for Carrageenan"/>
<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"/>
Expand All @@ -66,19 +62,15 @@
<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."/>
<artifact id="Bundle/4a7e17c1-a611-4cc7-9a71-8005a8b427ab" key="Bundle-4a7e17c1-a611-4cc7-9a71-8005a8b427ab" name="FHIR Document example of 3.2.P.5.1."/>
<artifact deprecated="true" id="ValueSet/genc-country-codes" key="ValueSet-genc-country-codes" name="GENC Country Code Values"/>
<artifact deprecated="true" id="CodeSystem/genc-country-codes-cs" key="CodeSystem-genc-country-codes-cs" name="GENC Country Codes"/>
<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 deprecated="true" id="ConceptMap/ISOtoGENC" key="ConceptMap-ISOtoGENC" name="ISO to GENC Country Code Mapping"/>
<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="StructureDefinition/mfg-test-site-organization" key="StructureDefinition-mfg-test-site-organization" name="Manufacturing and/or Test Site Organization"/>
<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"/>
Expand Down Expand Up @@ -121,7 +113,6 @@
<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="ValueSet/pqcmc-units-of-measure-terminology" key="ValueSet-pqcmc-units-of-measure-terminology" name="Units Of Measure 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"/>
Expand All @@ -136,7 +127,6 @@
<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 deprecated="true" key="profiles" name="(profiles)"/>
<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)"/>
Expand All @@ -147,4 +137,4 @@
<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>
</specification>
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