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 1.0.0 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
Draft as of 2024-11-13 |
<ValueSet xmlns="http://hl7.org/fhir">
<id value="capsule-classification-category"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: ValueSet capsule-classification-category</b></p><a name="capsule-classification-category"> </a><a name="hccapsule-classification-category"> </a><a name="capsule-classification-category-en-US"> </a><ul><li>Include these codes as defined in <a href="CodeSystem-cmc-ncit-dummy.html"><code>http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy</code></a><table class="none"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203348">C203348</a></td><td>Hard Gelatin Capsule Shell</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203349">C203349</a></td><td>Hard HPMC Capsule Shell</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203350">C203350</a></td><td>Hard Pullulan Capsule Shell</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203351">C203351</a></td><td>Hard PVA Capsule Shell</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203352">C203352</a></td><td>Hard Starch Capsule Shell</td></tr><tr><td><a href="CodeSystem-cmc-ncit-dummy.html#cmc-ncit-dummy-C203353">C203353</a></td><td>Soft Gelatin Capsule Shell</td></tr></table></li></ul></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
</extension>
<url
value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/capsule-classification-category"/>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.36.48.1"/>
</identifier>
<version value="1.0.0"/>
<name value="PqcmcCapsuleClassificationCategory"/>
<title value="Capsule Shell Classification Terminology"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2024-11-13T04:45:16+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
</telecom>
<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
</telecom>
</contact>
<description
value="A category of terminology used to qualify the information pertaining to the classification of a capsule in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
</jurisdiction>
<compose>
<include>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<concept>
<code value="C203348"/>
<display value="Hard Gelatin Capsule Shell"/>
</concept>
<concept>
<code value="C203349"/>
<display value="Hard HPMC Capsule Shell"/>
</concept>
<concept>
<code value="C203350"/>
<display value="Hard Pullulan Capsule Shell"/>
</concept>
<concept>
<code value="C203351"/>
<display value="Hard PVA Capsule Shell"/>
</concept>
<concept>
<code value="C203352"/>
<display value="Hard Starch Capsule Shell"/>
</concept>
<concept>
<code value="C203353"/>
<display value="Soft Gelatin Capsule Shell"/>
</concept>
</include>
</compose>
</ValueSet>