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GitHub-AmlodipineExample - added hasReleaseDate restriction on batch,…
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… added material name and identifier to material

Signed-off-by: Elisa Kendall <[email protected]>
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@ElisaKendall
ElisaKendall committed Dec 23, 2024
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55 changes: 53 additions & 2 deletions ISO/ISO11238-Substances.rdf
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<owl:imports rdf:resource="https://www.omg.org/spec/MVF/ISO1087-TerminologyScience/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/MVF/ISO1087-VocabularyForTermsAndDefinitions/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/MVF/MultipleVocabularyFacility/"/>
<owl:versionIRI rdf:resource="https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240901/ISO11238-Substances/"/>
<owl:versionIRI rdf:resource="https://spec.pistoiaalliance.org/idmp/ontology/ISO/20241201/ISO11238-Substances/"/>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221101/ISO11238-Substances.rdf version of this ontology was modified to relax the restriction on the property isStoichiometric with respect to chemical substances to optional from required (IDMP-380), and then reversed per the SME team and to conform with the IDMP standard.</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221201/ISO11238-Substances.rdf version of this ontology was modified to relax the restriction on the property hasStructure with respect to substances, single substances, and moieties to optional from at most one value, to allow for cases where there may be multiples, especially if mapping content from multiple repositories (IDMP-GitHub-244) to add definitions for certain stereochemistry nominals where they were missing (IDMP-GitHub-243), and to refactor concepts including substance, moiety, and add physical substance in order to distinguish specifications for substances, which is the primary perspective of the IDMP standards from physical substances, and rename substance constituency to substance composition, which is better understood by the user community. (IDMP-405)</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230201/ISO11238-Substances.rdf version of this ontology was modified to integrate a revised manufactured item and packaging strategy for UC-2. (IDMP-465)</skos:changeNote>
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<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20231201/ISO11238-Substances.rdf version of this ontology was augmented to build out the definition of source material (Figure 17 in the ISO standard) to support representation of biologics (IDMP-713) and to normalize the use of hasTextualName from MVF rather than from LCC.</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240301/ISO11238-Substances.rdf version of this ontology was augmented to add SKOS prefLabels for elements that have multiple labels (IDMP-734), to correct a wrong prefix for ReferenceSource, to make starting and resultant material roles disjoint, clean up URIs that had an erroneous final slash or were ill-formed, augment definitions with additional metadata from ISO 11238, and adjust the cardinality constraint on has quantity value range for amount to cover the case where there is both a quantity value range and reference range (GitHub-598).</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240601/ISO11238-Substances.rdf version of this ontology was augmented to integrate revisions to the content from the 1.2 revision of the OMG Commons Ontology Library (IDMP-774), and complete the linkage beween a manufacturer, a given business operation (facility), and the manufacturing site(s) at which a particular medicinal product (or component of a medicinal product) is manufactured (IDMP-779).</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240901/ISO11238-Substances.rdf version of this ontology was modified to fill gaps to support the CMC use case.</skos:changeNote>
<idmp-chg:hasMaturityLevel rdf:resource="&idmp-chg;Release"/>
<cmns-av:copyright>Copyright (c) 2022-2024 EDM Council, Inc.</cmns-av:copyright>
<cmns-av:copyright>Copyright (c) 2022-2024 Pistoia Alliance, Inc.</cmns-av:copyright>
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<owl:minQualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">0</owl:minQualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;hasName"/>
<owl:someValuesFrom rdf:resource="&idmp-sub;MaterialName"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-id;isIdentifiedBy"/>
<owl:someValuesFrom rdf:resource="&idmp-sub;MaterialIdentifier"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>material</rdfs:label>
<dct:source>ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.41</dct:source>
<dct:source>ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, clause 3.41, Figure 30</dct:source>
<owl:disjointWith rdf:resource="&idmp-sub;MolecularEntity"/>
<skos:definition>entity that has mass, occupies space and consists of one or more substances</skos:definition>
<cmns-av:explanatoryNote>Material is not defined herein at a molecular or astronomical level and can be described using classical Newtonian physics.</cmns-av:explanatoryNote>
<cmns-av:synonym>manufacturing material</cmns-av:synonym>
<cmns-av:synonym>manufacturing material substance</cmns-av:synonym>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;MaterialClassifier">
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<skos:note>Material components in the context of IDMP may be packaging (container) components or device components.</skos:note>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;MaterialIdentifier">
<rdfs:subClassOf rdf:resource="&cmns-cds;CodeElement"/>
<rdfs:subClassOf rdf:resource="&cmns-ra;RegisteredIdentifier"/>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-id;identifies"/>
<owl:someValuesFrom rdf:resource="&idmp-sub;Material"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>material identifier</rdfs:label>
<skos:definition>unique identifier for substances or specified substances of which certain products, packaging, or devices are made</skos:definition>
<cmns-av:adaptedFrom>ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 30</cmns-av:adaptedFrom>
<cmns-av:synonym>manufacturing material substance ID</cmns-av:synonym>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;MaterialName">
<rdfs:subClassOf rdf:resource="&cmns-cxtdsg;ContextualName"/>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&mvf;hasTextualName"/>
<owl:onDataRange rdf:resource="&xsd;string"/>
<owl:qualifiedCardinality rdf:datatype="&xsd;nonNegativeInteger">1</owl:qualifiedCardinality>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-dsg;isNameOf"/>
<owl:someValuesFrom rdf:resource="&idmp-sub;Material"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>material name</rdfs:label>
<skos:definition>designation for a substance or specified substance of which certain products, packaging, or devices are made</skos:definition>
<cmns-av:adaptedFrom>ISO 11238:2018 Health informatics - Identification of medicinal products (IDMP) - Data elements and structures for the unique identification and exchange of regulated information on substances, Figure 30</cmns-av:adaptedFrom>
<cmns-av:synonym>manufacturing material substance name</cmns-av:synonym>
</owl:Class>

<owl:Class rdf:about="&idmp-sub;MaterialRole">
<rdfs:subClassOf rdf:resource="&cmns-rlcmp;FunctionalRole"/>
<rdfs:subClassOf>
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9 changes: 8 additions & 1 deletion ISO/ISO11615-MedicinalProducts.rdf
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<owl:imports rdf:resource="https://www.omg.org/spec/MVF/ISO1087-TerminologyScience/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/MVF/ISO1087-VocabularyForTermsAndDefinitions/"/>
<owl:imports rdf:resource="https://www.omg.org/spec/MVF/MultipleVocabularyFacility/"/>
<owl:versionIRI rdf:resource="https://spec.pistoiaalliance.org/idmp/ontology/ISO/20241001/ISO11615-MedicinalProducts/"/>
<owl:versionIRI rdf:resource="https://spec.pistoiaalliance.org/idmp/ontology/ISO/20241201/ISO11615-MedicinalProducts/"/>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221001/ISO11615-MedicinalProducts.rdf version of this ontology was modified to rename &apos;ingredient role&apos;s to ingredients for clarification and refine the restrictions relating ingredients to pharmaceutical products and manufactured items per discussion at the Pistoia Alliance Conference Workshop on 3 November 2022 (IDMP-298). It was also extended to include concepts such as process, manufacturing process, process identifier, batch, batch identifier, lot, lot number, and others required in support of the regulatory to manufacturing bridge use case.</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20221201/ISO11615-MedicinalProducts.rdf version of this ontology was modified to refactor concepts including substance, moiety, and add physical substance in order to distinguish specifications for substances, which is the primary perspective of the IDMP standards from physical substances, and rename product constituency to product composition, which is better understood by the user community, and to move a couple of restrictions from ingredient to substance, including strength and whether or not that substance is potentially allergenic. (IDMP-405)</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20230201/ISO11615-MedicinalProducts.rdf version of this ontology was modified to integrate additional manufacturing and packaging details required for UC-2 (IDMP-465), to make manufactured item and pharmaceutical product disjoint, but both product specifications (IDMP-466), to change the status of this ontology to &apos;release&apos; (IDMP-525), to add content related to dose forms (IDMP-531, IDMP-538), and to complete the set of ingredient roles specified in the implementation guide for ISO 11615 (IDMP-304).</skos:changeNote>
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<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240601/ISO11615-MedicinalProducts.rdf version of this ontology was extended to complete the details for marketing authorization (IDMP-747) and marketing status (IDMP-750).</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240701/ISO11615-MedicinalProducts.rdf version of this ontology was extended to complete the details for medicinal product name (IDMP-745), integrate revisions to the content from the 1.2 revision of the OMG Commons Ontology Library (IDMP-774), complete the linkage beween a manufacturer, a given business operation (facility), and the manufacturing site(s) at which a particular medicinal product (or component of a medicinal product) is manufactured (IDMP-779), revised the name of concentration to concentration strength for consistency (IDMP-776), and added a link between the packaged medicinal product and marketing status record (IDMP-777).</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20240901/ISO11615-MedicinalProducts.rdf version of this ontology was modified to further simplify the packaging / container model (IDMP-744).</skos:changeNote>
<skos:changeNote>The https://spec.pistoiaalliance.org/idmp/ontology/ISO/20241001/ISO11615-MedicinalProducts.rdf version of this ontology was modified to fill gaps to support the CMC use case.</skos:changeNote>
<idmp-chg:hasMaturityLevel rdf:resource="&idmp-chg;Release"/>
<cmns-av:copyright>Copyright (c) 2022-2024 EDM Council, Inc.</cmns-av:copyright>
<cmns-av:copyright>Copyright (c) 2022-2024 Pistoia Alliance, Inc.</cmns-av:copyright>
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<owl:someValuesFrom rdf:resource="&idmp-mprd;BatchNumber"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:subClassOf>
<owl:Restriction>
<owl:onProperty rdf:resource="&cmns-stat;hasReleaseDate"/>
<owl:someValuesFrom rdf:resource="&cmns-dt;ExplicitDate"/>
</owl:Restriction>
</rdfs:subClassOf>
<rdfs:label>batch</rdfs:label>
<dct:source>ANSI/ISA S88: https://www.isa.org/products/ansi-isa-88-00-01-2010-batch-control-part-1-models (paragraph 3.1.6)</dct:source>
<skos:definition>material that is being produced or that has been produced by a single execution of a process that leads to the production of finite quantities of material by subjecting quantities of input materials to an ordered set of processing activities over a finite period of time</skos:definition>
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