Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
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<code value="C14258"/>
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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 class="res-header-id"><b>Generated Narrative: SubstanceDefinition fd84a8b5-9e96-451c-a5c6-097c943eb38a</b></p><a name="fd84a8b5-9e96-451c-a5c6-097c943eb38a"> </a><a name="hcfd84a8b5-9e96-451c-a5c6-097c943eb38a"> </a><a name="fd84a8b5-9e96-451c-a5c6-097c943eb38a-en-US"> </a><p><b>identifier</b>: Citric acid</p><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134009}">Company Standard</span></p><p><b>manufacturer</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov XF417D3PSL}">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><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<identifier>
<value value="Citric acid"/>
</identifier>
<classification>
<coding>
<system
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<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134009"/>
<display value="Company Standard"/>
</coding>
</grade>
<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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</type>
</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 class="res-header-id"><b>Generated Narrative: SubstanceDefinition d3a11b25-e160-4688-b807-6383364096fd</b></p><a name="d3a11b25-e160-4688-b807-6383364096fd"> </a><a name="hcd3a11b25-e160-4688-b807-6383364096fd"> </a><a name="d3a11b25-e160-4688-b807-6383364096fd-en-US"> </a><p><b>identifier</b>: water</p><p><b>classification</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C176793}">BP</span></p><p><b>manufacturer</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href="Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}">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><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td></tr></table></div>
</text>
<identifier>
<value value="water"/>
</identifier>
<classification>
<coding>
<system
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<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
<sourceMaterial>
<type>
<coding>
<system
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<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>
<div>
<table class="grid dict">
<tr>
<th scope="row"><b>Id: </b></th>
<td style="padding-left: 4px;">ab241f8c-d21e-4382-a70a-52190dbdf07e</td>
</tr>
<tr>
<th scope="row"><b>Version: </b></th>
<td style="padding-left: 4px;">1.0</td>
</tr>
<tr>
<th scope="row">
<b>
</b>
</th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<span>RawCitricacid</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Title: </b></th>
<td style="padding-left: 4px;">Raw Material (Carrageenan) Specification Example</td>
</tr>
<tr>
<th scope="row"><b>Type: </b></th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<b>system: </b> <span><a href="http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>
</p>
<p style="margin-bottom: 5px;">
<b>code: </b> <span>workflow-definition</span>
</p>
<p style="margin-bottom: 5px;">
<b>display: </b> <span>Workflow Definition</span>
</p>
<p style="margin-bottom: 5px;">
<b>system: </b> <span><a href="http://terminology.hl7.org/5.1.0/CodeSystem-v3-nciThesaurus.html">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>
</p>
<p style="margin-bottom: 5px;">
<b>code: </b> <span>C133931</span>
</p>
<p style="margin-bottom: 5px;">
<b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Subject: </b></th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<b>reference: </b> <span>urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Date: </b></th>
<td style="padding-left: 4px;">2023-11-28</td>
</tr>
<tr>
<th scope="row"><b>Actions: </b></th>
<td style="padding-left: 4px;">
<table class="grid-dict">
<tr>
<td>
<b>Single Stage Identification:</b>
<br/>
<b>Then:</b>
<table class="grid-dict">
<tr>
<td>
<b> Identification A:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Identification B:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Identification C:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Identification D:</b>
<br/>
</td>
</tr>
</table>
</td>
</tr>
<tr>
<td>
<b>Single Stage Microbial Limits:</b>
<br/>
<b>Then:</b>
<table class="grid-dict">
<tr>
<td>
<b> Total Bacterial Count:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Salmonella:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Escherichia Coli:</b>
<br/>
</td>
</tr>
</table>
</td>
</tr>
<tr>
<td>
<b>Single Stage Elemental Impurities:</b>
<br/>
<b>Then:</b>
<table class="grid-dict">
<tr>
<td>
<b> Cadmium (Cd):</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Mercury (Hg):</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Arsenic (As):</b>
<br/>
</td>
</tr>
<tr>
<td>
<b> Lead (Pb):</b>
<br/>
</td>
</tr>
</table>
</td>
</tr>
<tr>
<td>
<b>Single Stage Residual Solvents:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage Impurity: Insoluble Matter:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage Solubility in H2O:</b>
<br/>
</td>
</tr>
</table>
</td>
</tr>
</table>
</div>
</div>
</text>
<extension
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<valueCodeableConcept>
<coding>
<system
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<code value="C48660"/>
<display value="Not Applicable"/>
</coding>
</valueCodeableConcept>
</extension>
<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="C133931"/>
<display value="Raw Materials/Excipients/Intermediates/Reagents"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<reference value="urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703"/>
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<date value="2023-11-28"/>
<goal id="e512320e-0ffb-47d9-922a-5415aaa4cb30">
<description>
<text value="Viscous upon cooling"/>
</description>
<addresses>
<coding>
<system
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<code value="C134029"/>
<display value="Release"/>
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<code value="C134030"/>
<display value="Stability"/>
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<target>
<detailString value="Viscous upon cooling"/>
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<goal id="2c6e465b-4dec-4a09-9dc5-58c480009d27">
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<text value="Kappa, iota or lambda"/>
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<addresses>
<coding>
<system
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<coding>
<system
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<code value="C134030"/>
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<target>
<detailString value="Kappa, iota or Lambda"/>
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<goal id="c233a5f7-37e2-4b2b-9f04-cf1b25534865">
<description>
<text value="Blue, stringy precipitate forms"/>
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<coding>
<system
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<target>
<detailString value="Blue stringy precipitate forms"/>
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<goal id="c759888d-1eac-4a12-aa9b-403f395f2c18">
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<text value="FTIR matches standard"/>
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<system
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<system
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<display value="Stability"/>
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<target>
<detailString value="FTIR matches standard"/>
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<goal id="66d4035c-633a-49b1-b974-e3171911f44a">
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<text value="max 200 cfu/g"/>
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<coding>
<system
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<code value="C134030"/>
<display value="Stability"/>
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<target>
<detailQuantity>
<value value="200"/>
<comparator value="<="/>
<unit value="colony forming unit"/>
<system value="http://unitsofmeasure.org"/>
<code value="[CFU]"/>
</detailQuantity>
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<text value="Negative"/>
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<goal id="464f3063-0a4b-4408-9f4a-d6c0b8170097">
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<text value="<= 3 ppm"/>
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<system
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<code value="C134029"/>
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<system
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<code value="C134030"/>
<display value="Stability"/>
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<target>
<detailQuantity>
<value value="3"/>
<comparator value="<="/>
<unit value="part per million"/>
<system value="http://unitsofmeasure.org"/>
<code value="[ppm]"/>
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<goal id="03fbc16c-d4d4-40ac-8689-448bda831dac">
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<text value="<= 10 ppm"/>
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<system
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<system
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<code value="C134030"/>
<display value="Stability"/>
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</addresses>
<target>
<detailQuantity>
<value value="10"/>
<comparator value="<="/>
<unit value="part per million"/>
<system value="http://unitsofmeasure.org"/>
<code value="[ppm]"/>
</detailQuantity>
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<goal id="28aba010-126e-4c47-8611-367cdacdd87e">
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<text value="As Reported"/>
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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"/>
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<target>
<detailString value="As Reported"/>
</target>
</goal>
<goal id="4b3aa353-3bc7-463f-b4c2-defd041da2c7">
<description>
<text value="<= 2.0%"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<value value="2"/>
<comparator value="<="/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</detailQuantity>
</target>
</goal>
<goal id="8125f603-96e7-4f3e-8b13-c15c5870e6e6">
<description>
<text value="<30ml H2O @ 25C"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<value value="30"/>
<comparator value="<="/>
<unit value="milliliter"/>
<system value="http://unitsofmeasure.org"/>
<code value="mL"/>
</detailQuantity>
</target>
<target>
<detailQuantity>
<value value="25"/>
<comparator value="<="/>
<unit value="degree Celsius"/>
<system value="http://unitsofmeasure.org"/>
<code value="Cel"/>
</detailQuantity>
</target>
</goal>
<action id="428fa917-a7d3-4515-9b48-c9366acd673a">
<prefix value="Single Stage"/>
<title value="Identification"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C138993"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-001"/>
</documentation>
<action>
<title value="Identification A"/>
<goalId value="e512320e-0ffb-47d9-922a-5415aaa4cb30"/>
</action>
<action>
<title value="Identification B"/>
<goalId value="2c6e465b-4dec-4a09-9dc5-58c480009d27"/>
</action>
<action>
<title value="Identification C"/>
<goalId value="c233a5f7-37e2-4b2b-9f04-cf1b25534865"/>
</action>
<action>
<title value="Identification D"/>
<goalId value="c759888d-1eac-4a12-aa9b-403f395f2c18"/>
</action>
</action>
<action id="f7cbb73f-4220-4987-b498-c049230091ea">
<prefix value="Single Stage"/>
<title value="Microbial Limits"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134256"/>
<display value="Microbial Limits"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-002"/>
</documentation>
<action>
<title value="Total Bacterial Count"/>
<goalId value="66d4035c-633a-49b1-b974-e3171911f44a"/>
</action>
<action>
<title value="Salmonella"/>
<goalId value="95bf9d43-f337-4905-9c50-788b69d00843"/>
</action>
<action>
<title value="Escherichia Coli"/>
<goalId value="4e475e2c-c235-4433-b1e4-201a17e45796"/>
</action>
</action>
<action id="f5f8221c-f9ec-4b47-8ec7-90ff44f7388c">
<prefix value="Single Stage"/>
<title value="Elemental Impurities"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205014"/>
<display value="Elemental Impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-003"/>
</documentation>
<action>
<title value="Cadmium (Cd)"/>
<goalId value="af4ec6c3-4590-43f7-92e0-c8dae0e76e1f"/>
</action>
<action>
<title value="Mercury (Hg)"/>
<goalId value="b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73"/>
</action>
<action>
<title value="Arsenic (As)"/>
<goalId value="464f3063-0a4b-4408-9f4a-d6c0b8170097"/>
</action>
<action>
<title value="Lead (Pb)"/>
<goalId value="03fbc16c-d4d4-40ac-8689-448bda831dac"/>
</action>
</action>
<action id="37b44e91-529a-4d87-843b-ec3dd172c09f">
<prefix value="Single Stage"/>
<title value="Residual Solvents"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134002"/>
<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">
<prefix value="Single Stage"/>
<title value="Impurity: Insoluble Matter"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C204971"/>
<display value="Impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-005"/>
</documentation>
<goalId value="4b3aa353-3bc7-463f-b4c2-defd041da2c7"/>
</action>
<action id="055a79d2-3f6b-49ec-a129-6feac5c33812">
<prefix value="Single Stage"/>
<title value="Solubility in H2O"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C60821"/>
<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>
<div>
<table class="grid dict">
<tr>
<th scope="row"><b>Id: </b></th>
<td style="padding-left: 4px;">a2cba634-a481-4b07-9bd4-62c7ada31e1b</td>
</tr>
<tr>
<th scope="row"><b>Version: </b></th>
<td style="padding-left: 4px;">1.0</td>
</tr>
<tr>
<th scope="row">
<b>
</b>
</th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<span>CitricAcidSpecification</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Title: </b></th>
<td style="padding-left: 4px;">Citric acid specification Example</td>
</tr>
<tr>
<th scope="row"><b>Type: </b></th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<b>system: </b> <span><a href="http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>
</p>
<p style="margin-bottom: 5px;">
<b>code: </b> <span>workflow-definition</span>
</p>
<p style="margin-bottom: 5px;">
<b>display: </b> <span>Workflow Definition</span>
</p>
<p style="margin-bottom: 5px;">
<b>system: </b> <span><a href="http://terminology.hl7.org/5.1.0/CodeSystem-v3-nciThesaurus.html">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>
</p>
<p style="margin-bottom: 5px;">
<b>code: </b> <span>C133931</span>
</p>
<p style="margin-bottom: 5px;">
<b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Subject: </b></th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<b>reference: </b> <span>urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Date: </b></th>
<td style="padding-left: 4px;">2023-12-01</td>
</tr>
<tr>
<th scope="row"><b>Actions: </b></th>
<td style="padding-left: 4px;">
<table class="grid-dict">
<tr>
<td>
<b>Single Stage Appearance:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage Identification:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage [pH]:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage Residue on Ignition:</b>
<br/>
</td>
</tr>
</table>
</td>
</tr>
</table>
</div>
</div>
</text>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48660"/>
<display value="Not Applicable"/>
</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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133931"/>
<display value="Raw Materials/Excipients/Intermediates/Reagents"/>
</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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailString value="White solid"/>
</target>
</goal>
<goal id="59e2c94a-d383-4776-9b00-3b97b0741c9a">
<description>
<text value="IR spectrum conforms to reference standard"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailString value="IR spectrum conforms to reference standard"/>
</target>
</goal>
<goal id="a2ed2d13-e96a-4d7b-b825-c69afd334cf7">
<description>
<text value="pH 3.4-4.3"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<modifierExtension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range">
<extension url="low">
<valueQuantity>
<value value="3.4"/>
<comparator value=">="/>
<unit value="[pH]"/>
<system value="http://unitsofmeasure.org"/>
<code value="[pH]"/>
</valueQuantity>
</extension>
<extension url="high">
<valueQuantity>
<value value="4.3"/>
<comparator value="<="/>
<unit value="[pH]"/>
<system value="http://unitsofmeasure.org"/>
<code value="[pH]"/>
</valueQuantity>
</extension>
</modifierExtension>
</target>
</goal>
<goal id="e046aab8-b10f-4e13-89e6-bfa869a90b38">
<description>
<text value="residue <= 0.21%"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134030"/>
<display value="Stability"/>
</coding>
</addresses>
<target>
<detailQuantity>
<value value="0.21"/>
<comparator value="<="/>
<unit value="percent"/>
<system value="http://unitsofmeasure.org"/>
<code value="%"/>
</detailQuantity>
</target>
</goal>
<action id="fdf5e37f-ae97-48c1-9809-33aebff37199">
<prefix value="Single Stage"/>
<title value="Appearance"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205026"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C138990"/>
<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">
<prefix value="Single Stage"/>
<title value="Identification"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C138993"/>
<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">
<prefix value="Single Stage"/>
<title value="[pH]"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205029"/>
<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">
<prefix value="Single Stage"/>
<title value="Residue on Ignition"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<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">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134276"/>
<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>
<div>
<table class="grid dict">
<tr>
<th scope="row"><b>Id: </b></th>
<td style="padding-left: 4px;">5819b223-d3d2-419f-b617-b3a9a3625b89</td>
</tr>
<tr>
<th scope="row"><b>Version: </b></th>
<td style="padding-left: 4px;">1.0</td>
</tr>
<tr>
<th scope="row">
<b>
</b>
</th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<span>WaterSpecification</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Title: </b></th>
<td style="padding-left: 4px;">Water Specification Example</td>
</tr>
<tr>
<th scope="row"><b>Type: </b></th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<b>system: </b> <span><a href="http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>
</p>
<p style="margin-bottom: 5px;">
<b>code: </b> <span>workflow-definition</span>
</p>
<p style="margin-bottom: 5px;">
<b>display: </b> <span>Workflow Definition</span>
</p>
<p style="margin-bottom: 5px;">
<b>system: </b> <span><a href="http://terminology.hl7.org/5.1.0/CodeSystem-v3-nciThesaurus.html">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>
</p>
<p style="margin-bottom: 5px;">
<b>code: </b> <span>C133931</span>
</p>
<p style="margin-bottom: 5px;">
<b>display: </b> <span>Raw Materials/Excipients/Intermediates/Reagents</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Subject: </b></th>
<td style="padding-left: 4px;">
<p style="margin-bottom: 5px;">
<b>reference: </b> <span>urn:uuid:d3a11b25-e160-4688-b807-6383364096fd</span>
</p>
</td>
</tr>
<tr>
<th scope="row"><b>Date: </b></th>
<td style="padding-left: 4px;">2023-12-01</td>
</tr>
<tr>
<th scope="row"><b>Actions: </b></th>
<td style="padding-left: 4px;">
<table class="grid-dict">
<tr>
<td>
<b>Single Stage Color degree:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage Turbidity:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage Smell and taste:</b>
<br/>
</td>
</tr>
<tr>
<td>
<b>Single Stage Total hardness:</b>
<br/>
</td>
</tr>
</table>
</td>
</tr>
</table>
</div>
</div>
</text>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C48660"/>
<display value="Not Applicable"/>
</coding>
</valueCodeableConcept>
</extension>
<identifier>
<value value="WaterSpecification"/>
</identifier>
<version value="1.0"/>
<title value="Water 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C133931"/>
<display value="Raw Materials/Excipients/Intermediates/Reagents"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<reference value="urn:uuid:d3a11b25-e160-4688-b807-6383364096fd"/>
</subjectReference>
<date value="2023-12-01"/>
<goal id="1779ee35-8725-4322-ae82-89ed499f6864">
<description>
<text value="<=12 deg"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailQuantity>
<value value="12"/>
<comparator value="<="/>
<unit value="degree"/>
<system value="http://unitsofmeasure.org"/>
<code value="deg"/>
</detailQuantity>
</target>
</goal>
<goal id="2897e150-8465-48c7-9269-1cda86dc3075">
<description>
<text value="Conforms to reference standard"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailString value="Conforms to reference standard"/>
</target>
</goal>
<goal id="9c86ccba-a210-4ce5-9a23-b145d9f123c6">
<description>
<text value="Odorless"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailString value="Odorless"/>
</target>
</goal>
<goal id="de0f0d85-5617-4b07-98fc-9976b2dbf216">
<description>
<text value="<= 395mg/L"/>
</description>
<addresses>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailQuantity>
<value value="395"/>
<comparator value="<="/>
<unit value="milligram"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</detailQuantity>
</target>
</goal>
<action id="3668eb6f-797c-4325-8f41-160c951b4adc">
<prefix value="Single Stage"/>
<title value="Color degree"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Colorimetry"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205026"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134262"/>
<display value="Color of Solution"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-201"/>
</documentation>
<goalId value="1779ee35-8725-4322-ae82-89ed499f6864"/>
</action>
<action id="42cf5de4-2c64-48fc-a4d8-9e74066c36a3">
<prefix value="Single Stage"/>
<title value="Turbidity"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Spectrophotometer"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C74723"/>
<display value="Turbidity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-202"/>
</documentation>
<goalId value="2897e150-8465-48c7-9269-1cda86dc3075"/>
</action>
<action id="c552eee7-4dca-4a01-b291-5044d5132cc9">
<prefix value="Single Stage"/>
<title value="Smell and taste"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Smell"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C205026"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="2"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C139027"/>
<display value="Odor"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-203"/>
</documentation>
<goalId value="9c86ccba-a210-4ce5-9a23-b145d9f123c6"/>
</action>
<action id="b33b402a-0dc7-4953-a7b8-aa2efeb8434f">
<prefix value="Single Stage"/>
<title value="Total hardness"/>
<code>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Titration"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valuePositiveInt value="1"/>
</extension>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134264"/>
<display value="Hardness"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-204"/>
</documentation>
<goalId value="de0f0d85-5617-4b07-98fc-9976b2dbf216"/>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:49438799-e286-432c-b8d8-68ac77e7f519"/>
<resource>
<Organization>
<id value="49438799-e286-432c-b8d8-68ac77e7f519"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_49438799-e286-432c-b8d8-68ac77e7f519"> </a><p class="res-header-id"><b>Generated Narrative: Organization 49438799-e286-432c-b8d8-68ac77e7f519</b></p><a name="49438799-e286-432c-b8d8-68ac77e7f519"> </a><a name="hc49438799-e286-432c-b8d8-68ac77e7f519"> </a><a name="49438799-e286-432c-b8d8-68ac77e7f519-en-US"> </a><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>
<identifier>
<type>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265625"/>
</identifier>
<name value="J. Jones Research"/>
<contact>
<address>
<type value="postal"/>
<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#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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