Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_d332acdf-4874-407b-9950-528f14c6bea2"> </a><p class="res-header-id"><b>Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2</b></p><a name="d332acdf-4874-407b-9950-528f14c6bea2"> </a><a name="hcd332acdf-4874-407b-9950-528f14c6bea2"> </a><a name="d332acdf-4874-407b-9950-528f14c6bea2-en-US"> </a><p><b>identifier</b>: ExampleSpecification</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use ich_3.2.p.5.1}">Specification(s)</span></p><p><b>date</b>: 2023-12-15 22:33:13+0000</p><p><b>author</b>: <a href="Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</a></p><p><b>title</b>: Quality Specification for an example Drug Product</p></div>
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<td style="padding-left: 4px;">aa514363-d43f-4052-b44e-b67aa4d6dee7</td>
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<th scope="row"><b>Version: </b></th>
<td style="padding-left: 4px;">1.0</td>
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<th scope="row"><b>Title: </b></th>
<td style="padding-left: 4px;">Quality Specification for OXAZEPAM</td>
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<b>system: </b> <span><a href="http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>
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<b>code: </b> <span>C134021</span>
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<b>display: </b> <span>Drug Product</span>
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<b>reference: </b> <span>urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9</span>
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<th scope="row"><b>Date: </b></th>
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<b>Single Stage Spectrophotometry Identification:</b> <div><p>Alternate</p>
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<b>Single Stage Identity - Ferric Chloride:</b> <div><p>Alternate</p>
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<b>Single Stage Loss on Drying:</b>
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<b>Single Stage Readily Carbonizable Sub:</b>
<br/>
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<b>Single Stage Residue on ignition (Ash):</b>
<br/>
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<b>Single Stage Substances insoluble in sodium carbonate TS:</b>
<br/>
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<b>Single Stage Impurities - Chloride (Cl):</b>
<br/>
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<b>Single Stage Impurities - Sulfate (SO4):</b>
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<b>Single Stage Limit of Free Salicylic Acid:</b>
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<b>Single Stage Organic Volatile Impurities:</b>
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<b>Single Stage Assay Dry Basis:</b>
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<b> Dissolution - 30 minute:</b>
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value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<measure>
<text value="Average of 12 units"/>
</measure>
<detailQuantity>
<value value="80"/>
<comparator value="<="/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</detailQuantity>
</target>
<target>
<measure>
<text value="unit"/>
</measure>
<detailQuantity>
<value value="65"/>
<comparator value="<="/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
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</target>
</goal>
<goal id="15309a78-92a9-4cf9-aee1-452d6d2f7a91">
<description>
<text
value="Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q – 15%, no unit is less than Q – 25%"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<measure>
<text value="Average of 24 units"/>
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<detailQuantity>
<value value="80"/>
<comparator value="<="/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</detailQuantity>
</target>
<target>
<measure>
<text value="units less than Q – 15%"/>
</measure>
<detailQuantity>
<value value="2"/>
<comparator value="<="/>
<unit value="Amb a 1 units"/>
<system value="http://unitsofmeasure.org"/>
<code value="[Amb'a'1'U]"/>
</detailQuantity>
</target>
<target>
<measure>
<text value="units less than Q – 25%"/>
</measure>
<detailQuantity>
<value value="0"/>
<comparator value="<="/>
<unit value="Amb a 1 units"/>
<system value="http://unitsofmeasure.org"/>
<code value="[Amb'a'1'U]"/>
</detailQuantity>
</target>
</goal>
<goal id="666ace1e-bd29-4263-9ae2-2391106326bb">
<description>
<text value="n=12"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailInteger value="12"/>
</target>
</goal>
<action id="2047a6b6-e3fc-4071-8989-526297579091">
<prefix value="Single Stage"/>
<title value="Spectrophotometry Identification"/>
<description value="Alternate"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Spectrophotometry"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C138993"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <197>"/>
</documentation>
<goalId value="32649771-1290-4386-9cf7-7a72274f22b4"/>
<relatedAction>
<targetId value="84d64dd8-b799-418a-a713-a854c4d3c2b9"/>
<relationship value="concurrent"/>
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<action id="84d64dd8-b799-418a-a713-a854c4d3c2b9">
<linkId value="2047a6b6-e3fc-4071-8989-526297579091"/>
<prefix value="Single Stage"/>
<title value="Identity - Ferric Chloride"/>
<description value="Alternate"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="HPLC"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
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<coding>
<system
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<code value="C138993"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-01"/>
</documentation>
<goalId value="59a4ca76-858e-4d58-8e5f-88e75f51ec33"/>
<relatedAction>
<targetId value="2047a6b6-e3fc-4071-8989-526297579091"/>
<relationship value="concurrent"/>
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</action>
<action id="838e66ce-f4b0-47a5-8ea0-aa7882a84303">
<prefix value="Single Stage"/>
<title value="Loss on Drying"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
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<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134255"/>
<display value="Loss on Drying"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <731>"/>
</documentation>
<goalId value="c40aa176-e6aa-4fe4-869d-6550ee992903"/>
</action>
<action id="3510686b-fb93-4980-a41c-0a3754be7f37">
<prefix value="Single Stage"/>
<title value="Readily Carbonizable Sub"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
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<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205026"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134262"/>
<display value="Color of Solution"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <271>"/>
</documentation>
<goalId value="b122987d-586c-481b-951c-6202e660158d"/>
</action>
<action id="b2e18cc4-f494-4ef0-be34-810d8d4b439b">
<prefix value="Single Stage"/>
<title value="Residue on ignition (Ash)"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134276"/>
<display value="Residue on Ignition"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <281>"/>
</documentation>
<goalId value="929747ad-e83a-46f0-bbbc-133ee951e819"/>
</action>
<action id="d315a1c3-dd93-498d-8ae3-dc0d4b3bec75">
<prefix value="Single Stage"/>
<title value="Substances insoluble in sodium carbonate TS"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C193381"/>
<display value="Foreign and Particulate Matter"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-02"/>
</documentation>
<goalId value="8d7c85c2-7a4b-432e-ac94-226f296e4fca"/>
</action>
<action id="6ec15bbc-a78a-4351-9ad8-fcf97e839ab9">
<prefix value="Single Stage"/>
<title value="Impurities - Chloride (Cl)"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="FTIR"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205039"/>
<display value="Specified Identified Impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <221>"/>
</documentation>
<goalId value="de4f962a-d486-486d-8d84-f2d1635646b4"/>
</action>
<action id="fa31b425-896c-4b25-b693-ccdd14e0c8ee">
<prefix value="Single Stage"/>
<title value="Impurities - Sulfate (SO4)"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="FTIR"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205039"/>
<display value="Specified Identified Impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <221>"/>
</documentation>
<goalId value="b46dce64-a009-46cd-ab95-21d1d5b4df77"/>
</action>
<action id="cef5aa1a-8770-4f78-9bc3-da9f18b77e5c">
<prefix value="Single Stage"/>
<title value="Elemental Impurities - Limits"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="UV"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205014"/>
<display value="Elemental Impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <231>"/>
</documentation>
<goalId value="5566f501-37e1-49fb-8783-b20c074ec0c3"/>
</action>
<action id="d5871ee2-8b06-414c-91b4-4b30f5881c8a">
<prefix value="Single Stage"/>
<title value="Limit of Free Salicylic Acid"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Titration"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134254"/>
<display
value="Impurities/Degradation Products/Related Substances"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-03"/>
</documentation>
<goalId value="db19e3ab-e28b-4477-8bd7-2409093ed5a3"/>
</action>
<action id="e192fc72-c4b1-419f-8098-6f65037a3962">
<prefix value="Single Stage"/>
<title value="Organic Volatile Impurities"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134002"/>
<display value="Residual Solvent"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <467>"/>
</documentation>
<goalId value="82370588-7aae-4556-9262-a7f50dbd01aa"/>
<goalId value="cae2da87-c4b7-43d0-9e8e-c64d0d4df6c2"/>
<goalId value="28ad4d5b-d975-4f6e-9792-b3d9cc7ce279"/>
<goalId value="33fa051c-6b3c-4e4d-bd4e-09d39fc253b3"/>
</action>
<action id="b7e88ea0-3c61-49db-86ec-8d01f8b7667b">
<prefix value="Single Stage"/>
<title value="Assay Dry Basis"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C60819"/>
<display value="Assay"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204845"/>
<display value="Active Ingredient Content"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-04"/>
</documentation>
<goalId value="9100e938-42ff-4004-8473-ed5090d66f3a"/>
</action>
<action id="6d1ba5a8-6590-496a-ad6b-ca68cfda2878">
<title value="Dissolution - 30 minute"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134253"/>
<display value="Dissolution"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-05"/>
</documentation>
<action>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 1"/>
<goalId value="af260128-f105-4692-ba40-49f21f12ad46"/>
<goalId value="31d9dcac-bf72-420b-a415-c924155a83f4"/>
</action>
<action>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 2"/>
<goalId value="47c0d685-0b23-4637-9af8-a554e4fad7ec"/>
<goalId value="14d3dee8-e024-4367-b0a2-a2a809303ee0"/>
</action>
<action>
<linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
<prefix value="Stage 3"/>
<goalId value="15309a78-92a9-4cf9-aee1-452d6d2f7a91"/>
<goalId value="666ace1e-bd29-4263-9ae2-2391106326bb"/>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
<resource>
<MedicinalProductDefinition>
<id value="89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9</b></p><a name="89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a><a name="hc89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a><a name="89676a69-1fe7-422c-ab00-92abe4ef6ea9-en-US"> </a><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25158}">CAPSULE</span></p><p><b>route</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}">ORAL</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: OXAZEPAM</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 30mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">OXAZEPAM</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 60mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">PROPRANOLOL HYDROCHLORIDE</span></p></blockquote></blockquote></div>
</text>
<identifier>
<value value="Example2BeadDrug"/>
</identifier>
<combinedPharmaceuticalDoseForm>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C25158"/>
<display value="CAPSULE"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C38288"/>
<display value="ORAL"/>
</coding>
</route>
<name>
<productName value="OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96971"/>
<display value="Nonproprietary Name"/>
</coding>
<text value="Non-Proprietary"/>
</type>
<part>
<part value="OXAZEPAM"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="SCI"/>
</coding>
</type>
</part>
<part>
<part value="30mg"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="STR"/>
</coding>
<text value="OXAZEPAM"/>
</type>
</part>
<part>
<part value="PROPRANOLOL HYDROCHLORIDE"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="SCI"/>
</coding>
</type>
</part>
<part>
<part value="60mg"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
<code value="STR"/>
</coding>
<text value="PROPRANOLOL HYDROCHLORIDE"/>
</type>
</part>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
<resource>
<Organization>
<id value="4f3e9af1-306b-4fad-bf04-7881400b266a"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name="4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="hc4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="4f3e9af1-306b-4fad-bf04-7881400b266a-en-US"> </a><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<name value="Wunderwerke"/>
<contact>
<address>
<type value="postal"/>
<text
value="Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478"/>
<line value="123 Scenic Road"/>
<city value="Bridgeport"/>
<state value="CT"/>
<postalCode value="65478"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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