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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<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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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>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-104"/>
</documentation>
<goalId value="fc230a97-fd1a-4017-8603-822c5430a217"/>
<goalId value="8d6688e0-7412-4d64-afe8-b73d8aec596e"/>
<goalId value="f8e8343d-a37d-4b91-916b-f58d6947dc9c"/>
<goalId value="be7abaa1-0769-4560-af76-326e07d1df9a"/>
<goalId value="cfdd469d-020b-4047-946f-f513d58f007f"/>
<action>
<title value="Unidentified Impurities"/>
<action>
<prefix value="RRT"/>
<title value="2.2"/>
<goalId value="c5eea380-416f-4d19-a21e-c021f3c7c543"/>
</action>
<action>
<prefix value="RRT"/>
<title value="2.4"/>
<goalId value="41e19fa2-f568-443e-8bc1-6b0a6dca9d0c"/>
</action>
<action>
<prefix value="RRT"/>
<title value="3.41"/>
<goalId value="e493cb3d-45b6-4463-b9b6-e588c51e032c"/>
</action>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf"/>
<resource>
<SubstanceDefinition>
<id value="278736ef-2ddf-49e4-895c-3a9f34db36cf"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf</b></p><a name="278736ef-2ddf-49e4-895c-3a9f34db36cf"> </a><a name="hc278736ef-2ddf-49e4-895c-3a9f34db36cf"> </a><a name="278736ef-2ddf-49e4-895c-3a9f34db36cf-en-US"> </a><p><b>identifier</b>: Cochineal</p><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}">Company Standard</span></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov TZ8Z31B35M}">TZ8Z31B35M</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>Cochineal</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td><td><span title="Codes:">Dactylopius</span></td><td><span title="Codes:">cochineal</span></td><td><span title="Codes:{urn:iso:std:iso:3166 TUR}">Turkey</span></td></tr></table></div>
</text>
<identifier>
<value value="Cochineal"/>
</identifier>
<classification>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134009"/>
<display value="Company Standard"/>
</coding>
</grade>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="TZ8Z31B35M"/>
</coding>
</code>
</code>
<name>
<name value="Cochineal"/>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
<genus>
<text value="Dactylopius"/>
</genus>
<species>
<text value="cochineal"/>
</species>
<countryOfOrigin>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="TUR"/>
<display value="Turkey"/>
</coding>
</countryOfOrigin>
</sourceMaterial>
</SubstanceDefinition>
</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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