Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
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
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<timestamp value="2023-12-05T01:34:39.503Z"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"> </a><p><b>Generated Narrative: Composition</b><a name="5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"> </a><a name="hc5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"> </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 Composition "5c0d341e-6e4f-457c-811d-cfaf3eb62ecd" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ectd-composition-32s23.html">eCTD Substance Control of Materials Composition</a></p></div><p><b>identifier</b>: materials1</p><p><b>status</b>: final</p><p><b>type</b>: Substance Control of Materials <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-comp-section-types.html">Code System PQCMC Comp Section Types</a>#32S23)</span></p><p><b>date</b>: 2023-12-05 01:34:39+0000</p><p><b>author</b>: See on this page: urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519</p><p><b>title</b>: Control of Materials Example</p></div>
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<date value="2023-12-05T01:34:39.502Z"/>
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<reference value="urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"/>
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<title value="Control of Materials Example"/>
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<system
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<code value="32S231"/>
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<code value="32S231"/>
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<reference value="urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89"/>
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<entry>
<fullUrl value="urn:uuid:cd84a8b5-4e96-551c-15c6-c97c943eb38a"/>
<resource>
<SubstanceDefinition>
<id value="cd84a8b5-4e96-551c-15c6-c97c943eb38a"/>
<meta>
<profile
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_cd84a8b5-4e96-551c-15c6-c97c943eb38a"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="cd84a8b5-4e96-551c-15c6-c97c943eb38a"> </a><a name="hccd84a8b5-4e96-551c-15c6-c97c943eb38a"> </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 "cd84a8b5-4e96-551c-15c6-c97c943eb38a" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-routine-drug-substance.html">Routine Drug Substance</a></p></div><p><b>identifier</b>: salicylate</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: USP-NF <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134006)</span></p><p><b>manufacturer</b>: See on this page: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</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>R16CO5Y76E <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>#R16CO5Y76E)</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: Generic Name <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C97054)</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: 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></p><p><b>preferred</b>: true</p></blockquote></div>
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<code value="C48807"/>
<display value="Chemical"/>
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<grade>
<coding>
<system
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<code value="C134006"/>
<display value="USP-NF"/>
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<manufacturer>
<reference value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
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<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="R16CO5Y76E"/>
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<name>
<name value="ACETYLSALICYLIC ACID"/>
<type>
<coding>
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<code value="C97054"/>
<display value="Generic Name"/>
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<name>
<name value="ASPIRIN"/>
<type>
<coding>
<system
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<code value="C203355"/>
<display value="GSRS Preferred Term"/>
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<preferred value="true"/>
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<entry>
<fullUrl value="urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
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<Organization>
<id value="4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
<meta>
<profile
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<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><p><b>Generated Narrative: Organization</b><a name="4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><a name="hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </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 Organization "4b565cf3-5353-48af-8cd6-5ccf4e9fd579" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-mfg-test-site-organization.html">Manufacturing and/or Test Site Organization</a></p></div><p><b>identifier</b>: DUNS/783452221, FEI/6913973</p><p><b>name</b>: Manufacturing Site (J. Jones Research)</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>Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States</td></tr></table></div>
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<code value="C134003"/>
<display value="DUNS"/>
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<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="783452221"/>
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<identifier>
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<coding>
<system
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<code value="C134004"/>
<display value="FEI"/>
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<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="6913973"/>
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<name value="Manufacturing Site (J. Jones Research)"/>
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<line value="444 Grant Street"/>
<city value="Bedford"/>
<state value="NY"/>
<postalCode value="15600"/>
<country value="USA"/>
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<entry>
<fullUrl value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
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<Organization>
<id value="e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
<meta>
<profile
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </a><p><b>Generated Narrative: Organization</b><a name="e99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </a><a name="hce99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </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 Organization "e99bddfa-c1b5-435b-bbe8-24816b4e23e5" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-mfg-test-site-organization.html">Manufacturing and/or Test Site Organization</a></p></div><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: Vidinaid</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>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>
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<identifier>
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<system
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<code value="C134003"/>
<display value="DUNS"/>
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<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
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<identifier>
<type>
<coding>
<system
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<code value="C134004"/>
<display value="FEI"/>
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<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="6981397"/>
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<name value="Vidinaid"/>
<contact>
<address>
<text
value="Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA"/>
<line value="100 Stillwater Avenue"/>
<line value="Building #2"/>
<city value="Bangor"/>
<state value="ME"/>
<postalCode value="04401"/>
<country value="USA"/>
</address>
</contact>
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<entry>
<fullUrl value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
<resource>
<Organization>
<id value="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
<meta>
<profile
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><p><b>Generated Narrative: Organization</b><a name="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><a name="hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </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 Organization "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-supplier-organization.html">Supplier Organization</a></p></div><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>
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<identifier>
<type>
<coding>
<system
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<code value="C134003"/>
<display value="DUNS"/>
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</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="173265332"/>
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<name value="Mega Chem Supply"/>
<contact>
<address>
<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>
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<entry>
<fullUrl value="urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703"/>
<resource>
<SubstanceDefinition>
<id value="0efb1188-04f0-44ba-bfe7-ca6169ca8703"/>
<meta>
<profile
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_0efb1188-04f0-44ba-bfe7-ca6169ca8703"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="0efb1188-04f0-44ba-bfe7-ca6169ca8703"> </a><a name="hc0efb1188-04f0-44ba-bfe7-ca6169ca8703"> </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 "0efb1188-04f0-44ba-bfe7-ca6169ca8703" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-excipient.html">Excipient Drug Substance</a></p></div><p><b>identifier</b>: carrageenan</p><p><b>classification</b>: Structurally Diverse Substance <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C3641132)</span></p><p><b>grade</b>: Company Standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134009)</span></p><p><b>manufacturer</b>: See on this page: urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579</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>5C69YCD2YJ <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>#5C69YCD2YJ)</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>Carrageenan</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>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>palmaria <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>palmata <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>
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<identifier>
<value value="carrageenan"/>
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<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C3641132"/>
<display value="Structurally Diverse Substance"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134009"/>
<display value="Company Standard"/>
</coding>
</grade>
<manufacturer>
<reference value="urn:uuid:4b565cf3-5353-48af-8cd6-5ccf4e9fd579"/>
</manufacturer>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="5C69YCD2YJ"/>
</coding>
</code>
</code>
<name>
<name value="Carrageenan"/>
<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="palmaria"/>
</genus>
<species>
<text value="palmata"/>
</species>
<countryOfOrigin>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="USA"/>
<display value="United States of America"/>
</coding>
</countryOfOrigin>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a"/>
<resource>
<SubstanceDefinition>
<id value="fd84a8b5-9e96-451c-a5c6-097c943eb38a"/>
<meta>
<profile
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_fd84a8b5-9e96-451c-a5c6-097c943eb38a"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="fd84a8b5-9e96-451c-a5c6-097c943eb38a"> </a><a name="hcfd84a8b5-9e96-451c-a5c6-097c943eb38a"> </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 "fd84a8b5-9e96-451c-a5c6-097c943eb38a" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-excipient.html">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Citric acid</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: Company Standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134009)</span></p><p><b>manufacturer</b>: See on this page: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</p><p><b>supplier</b>: See on this page: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</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>XF417D3PSL <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>#XF417D3PSL)</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>ANHYDROUS CITRIC ACID</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></tr><tr><td style="display: none">*</td><td>Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></td></tr></table></div>
</text>
<identifier>
<value value="Citric acid"/>
</identifier>
<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134009"/>
<display value="Company Standard"/>
</coding>
</grade>
<manufacturer>
<reference value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
</manufacturer>
<supplier>
<reference value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
</supplier>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="XF417D3PSL"/>
</coding>
</code>
</code>
<name>
<name value="ANHYDROUS CITRIC ACID"/>
<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="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d3a11b25-e160-4688-b807-6383364096fd"/>
<resource>
<SubstanceDefinition>
<id value="d3a11b25-e160-4688-b807-6383364096fd"/>
<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_d3a11b25-e160-4688-b807-6383364096fd"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="d3a11b25-e160-4688-b807-6383364096fd"> </a><a name="hcd3a11b25-e160-4688-b807-6383364096fd"> </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 "d3a11b25-e160-4688-b807-6383364096fd" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-excipient.html">Excipient Drug Substance</a></p></div><p><b>identifier</b>: water</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</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>: See on this page: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</p><p><b>supplier</b>: See on this page: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</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>059QF0KO0R <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>#059QF0KO0R)</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>WATER</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></tr><tr><td style="display: none">*</td><td>Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></td></tr></table></div>
</text>
<identifier>
<value value="water"/>
</identifier>
<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48807"/>
<display value="Chemical"/>
</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:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
</manufacturer>
<supplier>
<reference value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
</supplier>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="059QF0KO0R"/>
</coding>
</code>
</code>
<name>
<name value="WATER"/>
<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="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</sourceMaterial>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:ab241f8c-d21e-4382-a70a-52190dbdf07e"/>
<resource>
<PlanDefinition>
<id value="ab241f8c-d21e-4382-a70a-52190dbdf07e"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_ab241f8c-d21e-4382-a70a-52190dbdf07e"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="ab241f8c-d21e-4382-a70a-52190dbdf07e"> </a><a name="hcab241f8c-d21e-4382-a70a-52190dbdf07e"> </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 PlanDefinition "ab241f8c-d21e-4382-a70a-52190dbdf07e" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-quality-specification.html">Quality Specification</a></p></div><p><b>Specification Type</b>: Raw Materials/Excipients/Intermediates/Reagents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C133931)</span></p><p><b>identifier</b>: RawCitricacid</p><p><b>version</b>: 1.0</p><p><b>title</b>: Raw Material (Carrageenan) Specification Example</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48660 "Not Applicable")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703</p><p><b>date</b>: 2023-11-28</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e512320e-0ffb-47d9-922a-5415aaa4cb30</blockquote><p><b>description</b>: Viscous upon cooling <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Viscous upon cooling <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>2c6e465b-4dec-4a09-9dc5-58c480009d27</blockquote><p><b>description</b>: Kappa, iota or lambda <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Kappa, iota or Lambda <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c233a5f7-37e2-4b2b-9f04-cf1b25534865</blockquote><p><b>description</b>: Blue, stringy precipitate forms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Blue stringy precipitate forms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c759888d-1eac-4a12-aa9b-403f395f2c18</blockquote><p><b>description</b>: FTIR matches standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>FTIR matches standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>66d4035c-633a-49b1-b974-e3171911f44a</blockquote><p><b>description</b>: max 200 cfu/g <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>200 colony forming units<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>95bf9d43-f337-4905-9c50-788b69d00843</blockquote><p><b>description</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>4e475e2c-c235-4433-b1e4-201a17e45796</blockquote><p><b>description</b>: Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>af4ec6c3-4590-43f7-92e0-c8dae0e76e1f</blockquote><p><b>description</b>: As Reported <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>As Reported <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73</blockquote><p><b>description</b>: As Reported <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>As Reported <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>464f3063-0a4b-4408-9f4a-d6c0b8170097</blockquote><p><b>description</b>: <= 3 ppm <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>3 parts per million<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>03fbc16c-d4d4-40ac-8689-448bda831dac</blockquote><p><b>description</b>: <= 10 ppm <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>10 parts per million<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>28aba010-126e-4c47-8611-367cdacdd87e</blockquote><p><b>description</b>: As Reported <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>As Reported <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>4b3aa353-3bc7-463f-b4c2-defd041da2c7</blockquote><p><b>description</b>: <= 2.0% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>2 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>8125f603-96e7-4f3e-8b13-c15c5870e6e6</blockquote><p><b>description</b>: <30ml H2O @ 25C <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><blockquote><p><b>target</b></p><p><b>detail</b>: 30 mL<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28254 = 'mL')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>detail</b>: 25 degree Celsius<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C42559 = 'Cel')</span></p></blockquote></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>428fa917-a7d3-4515-9b48-c9366acd673a</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-001</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>Identification A</td><td>e512320e-0ffb-47d9-922a-5415aaa4cb30</td></tr><tr><td style="display: none">*</td><td/><td>Identification B</td><td>2c6e465b-4dec-4a09-9dc5-58c480009d27</td></tr><tr><td style="display: none">*</td><td/><td>Identification C</td><td>c233a5f7-37e2-4b2b-9f04-cf1b25534865</td></tr><tr><td style="display: none">*</td><td/><td>Identification D</td><td>c759888d-1eac-4a12-aa9b-403f395f2c18</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>f7cbb73f-4220-4987-b498-c049230091ea</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Microbial Limits</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Microbial Limits <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC13)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-002</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>Total Bacterial Count</td><td>66d4035c-633a-49b1-b974-e3171911f44a</td></tr><tr><td style="display: none">*</td><td/><td>Salmonella</td><td>95bf9d43-f337-4905-9c50-788b69d00843</td></tr><tr><td style="display: none">*</td><td/><td>Escherichia Coli</td><td>4e475e2c-c235-4433-b1e4-201a17e45796</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>f5f8221c-f9ec-4b47-8ec7-90ff44f7388c</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Elemental Impurities</p><p><b>code</b>: UV <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, elemental impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC98)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-003</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>Cadmium (Cd)</td><td>af4ec6c3-4590-43f7-92e0-c8dae0e76e1f</td></tr><tr><td style="display: none">*</td><td/><td>Mercury (Hg)</td><td>b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73</td></tr><tr><td style="display: none">*</td><td/><td>Arsenic (As)</td><td>464f3063-0a4b-4408-9f4a-d6c0b8170097</td></tr><tr><td style="display: none">*</td><td/><td>Lead (Pb)</td><td>03fbc16c-d4d4-40ac-8689-448bda831dac</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>37b44e91-529a-4d87-843b-ec3dd172c09f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residual Solvents</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, residual solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC101)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-004</td></tr></table><p><b>goalId</b>: 28aba010-126e-4c47-8611-367cdacdd87e</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>25a64081-a0c2-4d72-8a48-538f81fcc35f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 5</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurity: Insoluble Matter</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-005</td></tr></table><p><b>goalId</b>: 4b3aa353-3bc7-463f-b4c2-defd041da2c7</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>055a79d2-3f6b-49ec-a129-6feac5c33812</blockquote><p><b>Test Order | Stage Sequence Order</b>: 6</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Solubility in H2O</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Solubility <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC24)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-006</td></tr></table><p><b>goalId</b>: 8125f603-96e7-4f3e-8b13-c15c5870e6e6</p></blockquote></div>
</text>
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url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension">
<valueCodeableConcept>
<coding>
<system
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<code value="C133931"/>
<display
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</valueCodeableConcept>
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<identifier>
<value value="RawCitricacid"/>
</identifier>
<version value="1.0"/>
<title value="Raw Material (Carrageenan) Specification Example"/>
<type>
<coding>
<system
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<code value="workflow-definition"/>
<display value="Workflow Definition"/>
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<coding>
<system
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<code value="C48660"/>
<display value="Not Applicable"/>
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<status value="active"/>
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<date value="2023-11-28"/>
<goal id="e512320e-0ffb-47d9-922a-5415aaa4cb30">
<description>
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<addresses>
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<code value="C134030"/>
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<target>
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<coding>
<system
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<code value="C48793"/>
<display value="EQ"/>
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<text value="Viscous upon cooling"/>
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<goal id="2c6e465b-4dec-4a09-9dc5-58c480009d27">
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<addresses>
<coding>
<system
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<code value="C134029"/>
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<addresses>
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<target>
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<coding>
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<display value="EQ"/>
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<text value="Kappa, iota or Lambda"/>
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<system
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<target>
<detailCodeableConcept>
<coding>
<system
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<code value="C48793"/>
<display value="EQ"/>
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<text value="Blue stringy precipitate forms"/>
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<goal id="c759888d-1eac-4a12-aa9b-403f395f2c18">
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<addresses>
<coding>
<system
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<addresses>
<coding>
<system
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<code value="C134030"/>
<display value="Stability"/>
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<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
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<text value="FTIR matches standard"/>
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<text value="max 200 cfu/g"/>
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<addresses>
<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
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<addresses>
<coding>
<system
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<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
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<valueCodeableConcept>
<coding>
<system
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<code value="C61586"/>
<display value="NMT (not more than)"/>
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</valueCodeableConcept>
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<value value="200"/>
<unit value="colony forming units"/>
<system
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<code value="C68742"/>
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<goal id="95bf9d43-f337-4905-9c50-788b69d00843">
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<text value="Negative"/>
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<addresses>
<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
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<addresses>
<coding>
<system
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<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
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<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="Negative"/>
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<goal id="4e475e2c-c235-4433-b1e4-201a17e45796">
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<text value="Negative"/>
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<addresses>
<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
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</addresses>
<addresses>
<coding>
<system
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<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="Negative"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="af4ec6c3-4590-43f7-92e0-c8dae0e76e1f">
<description>
<text value="As Reported"/>
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<addresses>
<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="As Reported"/>
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<goal id="b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73">
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<system
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<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="As Reported"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="464f3063-0a4b-4408-9f4a-d6c0b8170097">
<description>
<text value="<= 3 ppm"/>
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<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="3"/>
<unit value="parts per million"/>
<system
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<code value="C48523"/>
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</target>
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<goal id="03fbc16c-d4d4-40ac-8689-448bda831dac">
<description>
<text value="<= 10 ppm"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
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<addresses>
<coding>
<system
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<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
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<value value="10"/>
<unit value="parts per million"/>
<system
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<code value="C48523"/>
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<goal id="28aba010-126e-4c47-8611-367cdacdd87e">
<description>
<text value="As Reported"/>
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<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
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</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="As Reported"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="4b3aa353-3bc7-463f-b4c2-defd041da2c7">
<description>
<text value="<= 2.0%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
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</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="2"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
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</target>
</goal>
<goal id="8125f603-96e7-4f3e-8b13-c15c5870e6e6">
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<text value="<30ml H2O @ 25C"/>
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<code value="C134029"/>
<display value="Release"/>
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<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
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<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61585"/>
<display value="LT (less than)"/>
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<value value="30"/>
<unit value="mL"/>
<system
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<code value="C28254"/>
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<extension
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<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="25"/>
<unit value="degree Celsius"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C42559"/>
</detailQuantity>
</target>
</goal>
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<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<prefix value="Single Stage"/>
<title value="Identification"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC7"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-001"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.1"/>
</extension>
<title value="Identification A"/>
<goalId value="e512320e-0ffb-47d9-922a-5415aaa4cb30"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.2"/>
</extension>
<title value="Identification B"/>
<goalId value="2c6e465b-4dec-4a09-9dc5-58c480009d27"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.3"/>
</extension>
<title value="Identification C"/>
<goalId value="c233a5f7-37e2-4b2b-9f04-cf1b25534865"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.4"/>
</extension>
<title value="Identification D"/>
<goalId value="c759888d-1eac-4a12-aa9b-403f395f2c18"/>
</action>
</action>
<action id="f7cbb73f-4220-4987-b498-c049230091ea">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<prefix value="Single Stage"/>
<title value="Microbial Limits"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC13"/>
<display value="Microbial Limits"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-002"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2.1"/>
</extension>
<title value="Total Bacterial Count"/>
<goalId value="66d4035c-633a-49b1-b974-e3171911f44a"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2.2"/>
</extension>
<title value="Salmonella"/>
<goalId value="95bf9d43-f337-4905-9c50-788b69d00843"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2.3"/>
</extension>
<title value="Escherichia Coli"/>
<goalId value="4e475e2c-c235-4433-b1e4-201a17e45796"/>
</action>
</action>
<action id="f5f8221c-f9ec-4b47-8ec7-90ff44f7388c">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<prefix value="Single Stage"/>
<title value="Elemental Impurities"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="UV"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC98"/>
<display value="elemental impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-003"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3.1"/>
</extension>
<title value="Cadmium (Cd)"/>
<goalId value="af4ec6c3-4590-43f7-92e0-c8dae0e76e1f"/>
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<action>
<extension
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<valueDecimal value="3.2"/>
</extension>
<title value="Mercury (Hg)"/>
<goalId value="b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3.3"/>
</extension>
<title value="Arsenic (As)"/>
<goalId value="464f3063-0a4b-4408-9f4a-d6c0b8170097"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3.4"/>
</extension>
<title value="Lead (Pb)"/>
<goalId value="03fbc16c-d4d4-40ac-8689-448bda831dac"/>
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</action>
<action id="37b44e91-529a-4d87-843b-ec3dd172c09f">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="4"/>
</extension>
<prefix value="Single Stage"/>
<title value="Residual Solvents"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC101"/>
<display value="residual solvent"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-004"/>
</documentation>
<goalId value="28aba010-126e-4c47-8611-367cdacdd87e"/>
</action>
<action id="25a64081-a0c2-4d72-8a48-538f81fcc35f">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="5"/>
</extension>
<prefix value="Single Stage"/>
<title value="Impurity: Insoluble Matter"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-005"/>
</documentation>
<goalId value="4b3aa353-3bc7-463f-b4c2-defd041da2c7"/>
</action>
<action id="055a79d2-3f6b-49ec-a129-6feac5c33812">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="6"/>
</extension>
<prefix value="Single Stage"/>
<title value="Solubility in H2O"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC24"/>
<display value="Solubility"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-006"/>
</documentation>
<goalId value="8125f603-96e7-4f3e-8b13-c15c5870e6e6"/>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:a2cba634-a481-4b07-9bd4-62c7ada31e1b"/>
<resource>
<PlanDefinition>
<id value="a2cba634-a481-4b07-9bd4-62c7ada31e1b"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_a2cba634-a481-4b07-9bd4-62c7ada31e1b"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="a2cba634-a481-4b07-9bd4-62c7ada31e1b"> </a><a name="hca2cba634-a481-4b07-9bd4-62c7ada31e1b"> </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 PlanDefinition "a2cba634-a481-4b07-9bd4-62c7ada31e1b" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-quality-specification.html">Quality Specification</a></p></div><p><b>Specification Type</b>: Raw Materials/Excipients/Intermediates/Reagents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C133931)</span></p><p><b>identifier</b>: CitricAcidSpecification</p><p><b>version</b>: 1.0</p><p><b>title</b>: Citric acid specification Example</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48660 "Not Applicable")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a</p><p><b>date</b>: 2023-12-01</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9bc2bfdf-c9b1-440a-bafe-89f2674341d4</blockquote><p><b>description</b>: White Solid <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>White solid <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>59e2c94a-d383-4776-9b00-3b97b0741c9a</blockquote><p><b>description</b>: IR spectrum conforms to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>IR spectrum conforms to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>a2ed2d13-e96a-4d7b-b825-c69afd334cf7</blockquote><p><b>description</b>: pH 3.4-4.3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>3.4-4.3 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e046aab8-b10f-4e13-89e6-bfa869a90b38</blockquote><p><b>description</b>: residue <= 0.21% <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134030)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>0.21 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>fdf5e37f-ae97-48c1-9809-33aebff37199</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Appearance</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Organoleptic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC6)</span>, Description/Appearance <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC20)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-101</td></tr></table><p><b>goalId</b>: 9bc2bfdf-c9b1-440a-bafe-89f2674341d4</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>f6da4e9e-4954-4fd1-a78a-b297fea64a6f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: FTIR <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC7)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-102</td></tr></table><p><b>goalId</b>: 59e2c94a-d383-4776-9b00-3b97b0741c9a</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: pH</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC23)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-103</td></tr></table><p><b>goalId</b>: a2ed2d13-e96a-4d7b-b825-c69afd334cf7</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>aad4c3ce-985d-45ab-9d00-c2c01ca3813f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residue on Ignition</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Residue on Ignition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC38)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>USP <281></td></tr></table><p><b>goalId</b>: e046aab8-b10f-4e13-89e6-bfa869a90b38</p></blockquote></div>
</text>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C133931"/>
<display
value="Raw Materials/Excipients/Intermediates/Reagents"/>
</coding>
</valueCodeableConcept>
</extension>
<identifier>
<value value="CitricAcidSpecification"/>
</identifier>
<version value="1.0"/>
<title value="Citric acid specification Example"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48660"/>
<display value="Not Applicable"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<reference value="urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a"/>
</subjectReference>
<date value="2023-12-01"/>
<goal id="9bc2bfdf-c9b1-440a-bafe-89f2674341d4">
<description>
<text value="White Solid"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="White solid"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="59e2c94a-d383-4776-9b00-3b97b0741c9a">
<description>
<text value="IR spectrum conforms to reference standard"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="IR spectrum conforms to reference standard"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="a2ed2d13-e96a-4d7b-b825-c69afd334cf7">
<description>
<text value="pH 3.4-4.3"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailRange>
<low>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61583"/>
<display value="NLT (not less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="3.4"/>
<unit value="pH"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C45997"/>
</low>
<high>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="4.3"/>
<unit value="pH"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C45997"/>
</high>
</detailRange>
</target>
</goal>
<goal id="e046aab8-b10f-4e13-89e6-bfa869a90b38">
<description>
<text value="residue <= 0.21%"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="0.21"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<action id="fdf5e37f-ae97-48c1-9809-33aebff37199">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<prefix value="Single Stage"/>
<title value="Appearance"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC6"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC20"/>
<display value="Description/Appearance"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-101"/>
</documentation>
<goalId value="9bc2bfdf-c9b1-440a-bafe-89f2674341d4"/>
</action>
<action id="f6da4e9e-4954-4fd1-a78a-b297fea64a6f">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<prefix value="Single Stage"/>
<title value="Identification"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="FTIR"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC7"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-102"/>
</documentation>
<goalId value="59e2c94a-d383-4776-9b00-3b97b0741c9a"/>
</action>
<action id="a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<prefix value="Single Stage"/>
<title value="pH"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC23"/>
<display value="pH"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-103"/>
</documentation>
<goalId value="a2ed2d13-e96a-4d7b-b825-c69afd334cf7"/>
</action>
<action id="aad4c3ce-985d-45ab-9d00-c2c01ca3813f">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="4"/>
</extension>
<prefix value="Single Stage"/>
<title value="Residue on Ignition"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC38"/>
<display value="Residue on Ignition"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <281>"/>
</documentation>
<goalId value="e046aab8-b10f-4e13-89e6-bfa869a90b38"/>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:5819b223-d3d2-419f-b617-b3a9a3625b89"/>
<resource>
<PlanDefinition>
<id value="5819b223-d3d2-419f-b617-b3a9a3625b89"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_5819b223-d3d2-419f-b617-b3a9a3625b89"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="5819b223-d3d2-419f-b617-b3a9a3625b89"> </a><a name="hc5819b223-d3d2-419f-b617-b3a9a3625b89"> </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 PlanDefinition "5819b223-d3d2-419f-b617-b3a9a3625b89" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-quality-specification.html">Quality Specification</a></p></div><p><b>Specification Type</b>: Raw Materials/Excipients/Intermediates/Reagents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C133931)</span></p><p><b>identifier</b>: WaterSpecification</p><p><b>version</b>: 1.0</p><p><b>title</b>: Water Specification Example</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48660 "Not Applicable")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:d3a11b25-e160-4688-b807-6383364096fd</p><p><b>date</b>: 2023-12-01</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>1779ee35-8725-4322-ae82-89ed499f6864</blockquote><p><b>description</b>: <=12 deg <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>12 degrees of rotation<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68667 = 'deg')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>2897e150-8465-48c7-9269-1cda86dc3075</blockquote><p><b>description</b>: Conforms to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Conforms to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9c86ccba-a210-4ce5-9a23-b145d9f123c6</blockquote><p><b>description</b>: Odorless <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Odorless <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>de0f0d85-5617-4b07-98fc-9976b2dbf216</blockquote><p><b>description</b>: <= 395mg/L <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>395 milligram<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>3668eb6f-797c-4325-8f41-160c951b4adc</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Color degree</p><p><b>code</b>: Colorimetry <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Organoleptic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC6)</span>, Color of solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC22)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-201</td></tr></table><p><b>goalId</b>: 1779ee35-8725-4322-ae82-89ed499f6864</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>42cf5de4-2c64-48fc-a4d8-9e74066c36a3</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Turbidity</p><p><b>code</b>: Spectrophotometer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Turbidity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC51)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-202</td></tr></table><p><b>goalId</b>: 2897e150-8465-48c7-9269-1cda86dc3075</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>c552eee7-4dca-4a01-b291-5044d5132cc9</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Smell and taste</p><p><b>code</b>: Smell <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Organoleptic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC6)</span>, Odor <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC21)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-203</td></tr></table><p><b>goalId</b>: 9c86ccba-a210-4ce5-9a23-b145d9f123c6</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>b33b402a-0dc7-4953-a7b8-aa2efeb8434f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Total hardness</p><p><b>code</b>: Titration <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Hardness <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC20)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-204</td></tr></table><p><b>goalId</b>: de0f0d85-5617-4b07-98fc-9976b2dbf216</p></blockquote></div>
</text>
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<value value="395"/>
<unit value="milligram"/>
<system
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<title value="Color degree"/>
<code>
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<code value="C96103"/>
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<text value="Colorimetry"/>
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<code>
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<code value="C96103"/>
<display value="Proprietary"/>
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<text value="Spectrophotometer"/>
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<reason>
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<code value="TC51"/>
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<code value="C96103"/>
<display value="Proprietary"/>
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<text value="Smell"/>
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<display value="Organoleptic"/>
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<display value="Odor"/>
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<documentation>
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<label value="EX-TEST-203"/>
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<goalId value="9c86ccba-a210-4ce5-9a23-b145d9f123c6"/>
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<documentation>
<type value="documentation"/>
<label value="EX-TEST-204"/>
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<meta>
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<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_49438799-e286-432c-b8d8-68ac77e7f519"> </a><p><b>Generated Narrative: Organization</b><a name="49438799-e286-432c-b8d8-68ac77e7f519"> </a><a name="hc49438799-e286-432c-b8d8-68ac77e7f519"> </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 Organization "49438799-e286-432c-b8d8-68ac77e7f519" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-cmc-sponsor-organization.html">Sponsor Organization</a></p></div><p><b>identifier</b>: DUNS/143265625</p><p><b>name</b>: J. Jones Research</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>J. Jones Research, 123 Broad Way, New York, NY, United States</td></tr></table></div>
</text>
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<system value="urn:oid:1.3.6.1.4.1.519.1"/>
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<name value="J. Jones Research"/>
<contact>
<address>
<text
value="J. Jones Research, 123 Broad Way, New York, NY, United States"/>
<line value="123 Broad Way"/>
<city value="New York"/>
<state value="NY"/>
<postalCode value="00062"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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