This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
<SubstanceDefinition xmlns="http://hl7.org/fhir">
<id value="496f83ad-2365-4b12-8672-a349d99f7d67"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="496f83ad-2365-4b12-8672-a349d99f7d67"> </a><a name="hc496f83ad-2365-4b12-8672-a349d99f7d67"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition "496f83ad-2365-4b12-8672-a349d99f7d67" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-component-substance.html">Component Substance</a></p></div><p><b>identifier</b>: Grape skin extract</p><p><b>classification</b>: Mixture <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C45305)</span></p><p><b>grade</b>: BP <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C176793)</span></p><p><b>manufacturer</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049">urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</a></p><p><b>supplier</b>: <a href="Bundle-bd0f0a7a-27ea-4884-801d-bd0546e80888.html#urn-uuid-8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9">urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9</a></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>3GOV20705G <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#3GOV20705G)</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>WINE GRAPE</td><td>GSRS Preferred Term <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C203355)</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>Part</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style="display: none">*</td><td>Plant <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C14258)</span></td><td>Vitis <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>vinifera <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>skin <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>United States of America <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#USA)</span></td></tr></table></div>
</text>
<identifier>
<value value="Grape skin extract"/>
</identifier>
<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C45305"/>
<display value="Mixture"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C176793"/>
<display value="BP"/>
</coding>
</grade>
<manufacturer>
<reference value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
</manufacturer>
<supplier>
<reference value="urn:uuid:8ee60ed1-e22f-4d3b-ab08-8986e4e8e1d9"/>
</supplier>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="3GOV20705G"/>
</coding>
</code>
</code>
<name>
<name value="WINE GRAPE"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C14258"/>
<display value="Plant"/>
</coding>
</type>
<genus>
<text value="Vitis"/>
</genus>
<species>
<text value="vinifera"/>
</species>
<part>
<text value="skin"/>
</part>
<countryOfOrigin>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="USA"/>
<display value="United States of America"/>
</coding>
</countryOfOrigin>
</sourceMaterial>
</SubstanceDefinition>