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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<td style="padding-left: 4px;">cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93</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 an API</td>
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<th scope="row"><b>Type: </b></th>
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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>C134022</span>
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<b>display: </b> <span>Drug Substance</span>
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<b>reference: </b> <span>urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf</span>
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<th scope="row"><b>Date: </b></th>
<td style="padding-left: 4px;">2022-12-08</td>
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<td style="padding-left: 4px;">2022-12-08</td>
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<b> Microbiological Examination of Nonsterile Products:</b>
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<b>Then:</b>
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<b>Stage 1 Staphylococcus aureus:</b>
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<b>Stage 2 Pseudomonas aeruginosa:</b>
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<b>Stage 3 Bacillus subtilis:</b>
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<b>Stage 4 Total Aerobic Microbial Count (TAMC):</b>
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<b>Stage 5 Total Yeasts and Molds Count (TYMC):</b>
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<preferred value="true"/>
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</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
<resource>
<Organization>
<id value="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
<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_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><p class="res-header-id"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><a name="hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><a name="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049-en-US"> </a><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</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>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</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="173265332"/>
</identifier>
<name value="Mega Chem Supply"/>
<contact>
<address>
<type value="postal"/>
<text
value="Mega Chem Supply, 350 W Main Street, Rochester, NY, United States"/>
<line value="350 W Main Street"/>
<city value="Rochester"/>
<state value="NY"/>
<postalCode value="14608"/>
<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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