Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

: eCTD Document for 32S23 - XML Representation

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          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"> </a><p class="res-header-id"><b>Generated Narrative: Composition 5c0d341e-6e4f-457c-811d-cfaf3eb62ecd</b></p><a name="5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"> </a><a name="hc5c0d341e-6e4f-457c-811d-cfaf3eb62ecd"> </a><a name="5c0d341e-6e4f-457c-811d-cfaf3eb62ecd-en-US"> </a><p><b>identifier</b>: materials1</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types 32S23}">Substance Control of Materials</span></p><p><b>date</b>: 2023-12-05 01:34:39+0000</p><p><b>author</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-49438799-e286-432c-b8d8-68ac77e7f519">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>title</b>: Control of Materials Example</p></div>
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              <system
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              <code value="32S231"/>
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              <system
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        <meta>
          <profile
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        <text>
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          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_cd84a8b5-4e96-551c-15c6-c97c943eb38a"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a</b></p><a name="cd84a8b5-4e96-551c-15c6-c97c943eb38a"> </a><a name="hccd84a8b5-4e96-551c-15c6-c97c943eb38a"> </a><a name="cd84a8b5-4e96-551c-15c6-c97c943eb38a-en-US"> </a><p><b>identifier</b>: salicylate</p><p><b>classification</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134006}">USP-NF</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><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 R16CO5Y76E}">R16CO5Y76E</span></td></tr></table><blockquote><p><b>name</b></p><p><b>name</b>: ACETYLSALICYLIC ACID</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C97054}">Generic Name</span></p></blockquote><blockquote><p><b>name</b></p><p><b>name</b>: ASPIRIN</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C203355}">GSRS Preferred Term</span></p><p><b>preferred</b>: true</p></blockquote></div>
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          <value value="salicylate"/>
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        <classification>
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            <system
                    value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
            <code value="C48807"/>
            <display value="Chemical"/>
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        </classification>
        <grade>
          <coding>
            <system
                    value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
            <code value="C134006"/>
            <display value="USP-NF"/>
          </coding>
        </grade>
        <manufacturer>
          <reference value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
        </manufacturer>
        <code>
          <code>
            <coding>
              <system value="http://fdasis.nlm.nih.gov"/>
              <code value="R16CO5Y76E"/>
            </coding>
          </code>
        </code>
        <name>
          <name value="ACETYLSALICYLIC ACID"/>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
              <code value="C97054"/>
              <display value="Generic Name"/>
            </coding>
          </type>
        </name>
        <name>
          <name value="ASPIRIN"/>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
              <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
                   value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
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        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579</b></p><a name="4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><a name="hc4b565cf3-5353-48af-8cd6-5ccf4e9fd579"> </a><a name="4b565cf3-5353-48af-8cd6-5ccf4e9fd579-en-US"> </a><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>
        </text>
        <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="783452221"/>
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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="6913973"/>
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        <name value="Manufacturing Site (J. Jones Research)"/>
        <contact>
          <address>
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            <text
                  value="Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States"/>
            <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 class="res-header-id"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name="e99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </a><a name="hce99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </a><a name="e99bddfa-c1b5-435b-bbe8-24816b4e23e5-en-US"> </a><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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              <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>
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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>
            <type value="postal"/>
            <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"/>
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  <entry>
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        <meta>
          <profile
                   value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
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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 class="res-header-id"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><a name="hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><a name="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049-en-US"> </a><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Address</b></td></tr><tr><td style="display: none">*</td><td>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>
        </text>
        <identifier>
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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="173265332"/>
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        <name value="Mega Chem Supply"/>
        <contact>
          <address>
            <type value="postal"/>
            <text
                  value="Mega Chem Supply, 350 W Main Street, Rochester, NY, United States"/>
            <line value="350 W Main Street"/>
            <city value="Rochester"/>
            <state value="NY"/>
            <postalCode value="14608"/>
            <country value="USA"/>
          </address>
        </contact>
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  <entry>
    <fullUrl value="urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703"/>
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        <id value="0efb1188-04f0-44ba-bfe7-ca6169ca8703"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"/>
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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 class="res-header-id"><b>Generated Narrative: SubstanceDefinition 0efb1188-04f0-44ba-bfe7-ca6169ca8703</b></p><a name="0efb1188-04f0-44ba-bfe7-ca6169ca8703"> </a><a name="hc0efb1188-04f0-44ba-bfe7-ca6169ca8703"> </a><a name="0efb1188-04f0-44ba-bfe7-ca6169ca8703-en-US"> </a><p><b>identifier</b>: carrageenan</p><p><b>classification</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C3641132}">Structurally Diverse Substance</span></p><p><b>grade</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134009}">Company Standard</span></p><p><b>manufacturer</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-4b565cf3-5353-48af-8cd6-5ccf4e9fd579">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+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 5C69YCD2YJ}">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><span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy 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><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C14258}">Plant</span></td><td><span title="Codes:">palmaria</span></td><td><span title="Codes:">palmata</span></td><td><span title="Codes:{urn:iso:std:iso:3166 USA}">United States of America</span></td></tr></table></div>
        </text>
        <identifier>
          <value value="carrageenan"/>
        </identifier>
        <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>
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  </entry>
  <entry>
    <fullUrl value="urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a"/>
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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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48807}">Chemical</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 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48807}">Chemical</span></p><p><b>grade</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy 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://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48807}">Chemical</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 class="res-header-id"><b>Generated Narrative: PlanDefinition ab241f8c-d21e-4382-a70a-52190dbdf07e</b></p><a name="ab241f8c-d21e-4382-a70a-52190dbdf07e"> </a><a name="hcab241f8c-d21e-4382-a70a-52190dbdf07e"> </a><a name="ab241f8c-d21e-4382-a70a-52190dbdf07e-en-US"> </a><p><b>Specification Status</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48660}">Not Applicable</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>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/plan-definition-type workflow-definition}, {http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C133931}">Workflow Definition</span></p><p><b>status</b>: Active</p><p><b>subject</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-0efb1188-04f0-44ba-bfe7-ca6169ca8703">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></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>: <span title="Codes:">Viscous upon cooling</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">Kappa, iota or lambda</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">Blue, stringy precipitate forms</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">FTIR matches standard</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">max 200 cfu/g</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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>&lt;=200 colony forming unit<span style="background: LightGoldenRodYellow"> (Details: UCUM  code[CFU] = '[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>: <span title="Codes:">Negative</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">Negative</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">As Reported</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">As Reported</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">&lt;= 3 ppm</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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>&lt;=3 part per million<span style="background: LightGoldenRodYellow"> (Details: UCUM  code[ppm] = '[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>: <span title="Codes:">&lt;= 10 ppm</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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>&lt;=10 part per million<span style="background: LightGoldenRodYellow"> (Details: UCUM  code[ppm] = '[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>: <span title="Codes:">As Reported</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">&lt;= 2.0%</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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>&lt;=2 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</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>: <span title="Codes:">&lt;30ml H2O @ 25C</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</span></p><blockquote><p><b>target</b></p><p><b>detail</b>: &lt;=30 milliliter<span style="background: LightGoldenRodYellow"> (Details: UCUM  codemL = 'mL')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>detail</b>: &lt;=25 degree Celsius<span style="background: LightGoldenRodYellow"> (Details: UCUM  codeCel = '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>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C138993}">Identification</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>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td>Identification A</td><td>e512320e-0ffb-47d9-922a-5415aaa4cb30</td></tr><tr><td style="display: none">*</td><td>Identification B</td><td>2c6e465b-4dec-4a09-9dc5-58c480009d27</td></tr><tr><td style="display: none">*</td><td>Identification C</td><td>c233a5f7-37e2-4b2b-9f04-cf1b25534865</td></tr><tr><td style="display: none">*</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>prefix</b>: Single Stage</p><p><b>title</b>: Microbial Limits</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134256}">Microbial Limits</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>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td>Total Bacterial Count</td><td>66d4035c-633a-49b1-b974-e3171911f44a</td></tr><tr><td style="display: none">*</td><td>Salmonella</td><td>95bf9d43-f337-4905-9c50-788b69d00843</td></tr><tr><td style="display: none">*</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>prefix</b>: Single Stage</p><p><b>title</b>: Elemental Impurities</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">UV</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C204971}">Impurity</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C205014}">Elemental Impurity</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>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td>Cadmium (Cd)</td><td>af4ec6c3-4590-43f7-92e0-c8dae0e76e1f</td></tr><tr><td style="display: none">*</td><td>Mercury (Hg)</td><td>b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73</td></tr><tr><td style="display: none">*</td><td>Arsenic (As)</td><td>464f3063-0a4b-4408-9f4a-d6c0b8170097</td></tr><tr><td style="display: none">*</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>prefix</b>: Single Stage</p><p><b>title</b>: Residual Solvents</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C204971}">Impurity</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134002}">Residual Solvent</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>prefix</b>: Single Stage</p><p><b>title</b>: Impurity: Insoluble Matter</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C204971}">Impurity</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>prefix</b>: Single Stage</p><p><b>title</b>: Solubility in H2O</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C60821}">Solubility</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>
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            <title value="Total Bacterial Count"/>
            <goalId value="66d4035c-633a-49b1-b974-e3171911f44a"/>
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            <text value="UV"/>
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              <display value="Impurity"/>
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              <code value="C96103"/>
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              <code value="C60821"/>
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        <meta>
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          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_a2cba634-a481-4b07-9bd4-62c7ada31e1b"> </a><p class="res-header-id"><b>Generated Narrative: PlanDefinition a2cba634-a481-4b07-9bd4-62c7ada31e1b</b></p><a name="a2cba634-a481-4b07-9bd4-62c7ada31e1b"> </a><a name="hca2cba634-a481-4b07-9bd4-62c7ada31e1b"> </a><a name="a2cba634-a481-4b07-9bd4-62c7ada31e1b-en-US"> </a><p><b>Specification Status</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48660}">Not Applicable</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>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/plan-definition-type workflow-definition}, {http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C133931}">Workflow Definition</span></p><p><b>status</b>: Active</p><p><b>subject</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-fd84a8b5-9e96-451c-a5c6-097c943eb38a">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></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>: <span title="Codes:">White Solid</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">IR spectrum conforms to reference standard</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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</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>: <span title="Codes:">pH 3.4-4.3</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ModifierExtension</b></td></tr><tr><td style="display: none">*</td><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>: <span title="Codes:">residue &lt;= 0.21%</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134030}">Stability</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>&lt;=0.21 percent<span style="background: LightGoldenRodYellow"> (Details: UCUM  code% = '%')</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>prefix</b>: Single Stage</p><p><b>title</b>: Appearance</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C205026}">Organoleptic</span>, <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C138990}">Description/Appearance</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>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">FTIR</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C138993}">Identification</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>prefix</b>: Single Stage</p><p><b>title</b>: [pH]</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C205029}">pH</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>prefix</b>: Single Stage</p><p><b>title</b>: Residue on Ignition</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96102}">Visual</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134276}">Residue on Ignition</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 &lt;281&gt;</td></tr></table><p><b>goalId</b>: e046aab8-b10f-4e13-89e6-bfa869a90b38</p></blockquote></div>
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              <code value="C205026"/>
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              <code value="C138990"/>
              <display value="Description/Appearance"/>
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          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_5819b223-d3d2-419f-b617-b3a9a3625b89"> </a><p class="res-header-id"><b>Generated Narrative: PlanDefinition 5819b223-d3d2-419f-b617-b3a9a3625b89</b></p><a name="5819b223-d3d2-419f-b617-b3a9a3625b89"> </a><a name="hc5819b223-d3d2-419f-b617-b3a9a3625b89"> </a><a name="5819b223-d3d2-419f-b617-b3a9a3625b89-en-US"> </a><p><b>Specification Status</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C48660}">Not Applicable</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>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/plan-definition-type workflow-definition}, {http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C133931}">Workflow Definition</span></p><p><b>status</b>: Active</p><p><b>subject</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-d3a11b25-e160-4688-b807-6383364096fd">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></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>: <span title="Codes:">&lt;=12 deg</span></p><p><b>addresses</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C134029}">Release</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>&lt;=12 degree<span style="background: LightGoldenRodYellow"> (Details: UCUM  codedeg = '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>: <span title="Codes:">Conforms to 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Solution</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>prefix</b>: Single Stage</p><p><b>title</b>: Turbidity</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C96103}">Spectrophotometer</span></p><p><b>reason</b>: <span title="Codes:{http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy C74723}">Turbidity</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>: 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            <state value="NY"/>
            <postalCode value="00062"/>
            <country value="USA"/>
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</Bundle>