Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 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

## : 3.2.P.4 Bundle - XML Representation

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    <Bundle xmlns="http://hl7.org/fhir">
      <id value="SpecificationExcipientBundle"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"/>
      </meta>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:uuid:813b4312-8b6d-42cc-9b8c-8bb6463388cc"/>
      </identifier>
      <type value="document"/>
      <timestamp value="2024-01-01T19:42:35.255Z"/>
      <entry>
        <fullUrl value="urn:uuid:4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"/>
        <resource>
          <Composition>
            <id value="4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"> </a><p class="res-header-id"><b>Generated Narrative: Composition 4bd1ed57-852b-42be-a9b0-355f8a2aa7d4</b></p><a name="4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"> </a><a name="hc4bd1ed57-852b-42be-a9b0-355f8a2aa7d4"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ectd-composition-sp4151.html">eCTD Specification</a></p></div><p><b>identifier</b>: CochinealSpecificationComposition</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.4}">m3.2.p.4 control of excipients</span></p><p><b>date</b>: 2024-01-01 19:42:35+0000</p><p><b>author</b>: <a href="Bundle-BatchFormulaBundle.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>title</b>: Cochineal specification Composition Example</p></div>
            </text>
            <identifier>
              <value value="CochinealSpecificationComposition"/>
            </identifier>
            <status value="final"/>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
                <code value="ich_3.2.p.4"/>
                <display value="m3.2.p.4 control of excipients"/>
              </coding>
            </type>
            <date value="2024-01-01T19:42:35.254Z"/>
            <author>
              <reference value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
            </author>
            <title value="Cochineal specification Composition Example"/>
            <section>
              <title value="32P40"/>
              <entry>
                <reference value="urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e"/>
              </entry>
            </section>
          </Composition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:37bf5cc0-33bf-478b-b84e-ccb35143ef6e"/>
        <resource>
          <PlanDefinition>
            <id value="37bf5cc0-33bf-478b-b84e-ccb35143ef6e"/>
            <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_37bf5cc0-33bf-478b-b84e-ccb35143ef6e"> </a>
    <div>
        <table class="grid dict">

            <tr>
                <th scope="row"><b>Id: </b></th>
                <td style="padding-left: 4px;">37bf5cc0-33bf-478b-b84e-ccb35143ef6e</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>CochinealSpecification</span>
                    </p>

                </td>
            </tr>

            <tr>
                <th scope="row"><b>Title: </b></th>
                <td style="padding-left: 4px;">Cochineal 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/6.4.0/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="https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf">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:278736ef-2ddf-49e4-895c-3a9f34db36cf</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>

                        <tr>
                            <td>

                                <b>Single Stage Impurities:</b>

                                <br/>

                                <b>Then:</b>
                                <table class="grid-dict">

                                    <tr>
                                        <td>

                                            <b> Unidentified Impurities:</b>

                                            <br/>

                                            <b>Then:</b> <i>Additional sub-actions not displayed</i>

                                        </td>
                                    </tr>

                                </table>

                            </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="CochinealSpecification"/>
            </identifier>
            <version value="1.0"/>
            <title value="Cochineal specification Example"/>
            <type>
              <coding>
                <system
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                <code value="workflow-definition"/>
                <display value="Workflow Definition"/>
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              <coding>
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                <code value="C133931"/>
                <display value="Raw Materials/Excipients/Intermediates/Reagents"/>
              </coding>
            </type>
            <status value="active"/>
            <subjectReference>
              <reference value="urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf"/>
            </subjectReference>
            <date value="2023-12-01"/>
            <goal id="e900181a-876c-4ed6-ac96-d5a73c3d6767">
              <description>
                <text value="White Solid"/>
              </description>
              <addresses>
                <coding>
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                  <code value="C134029"/>
                  <display value="Release"/>
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              <addresses>
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                  <display value="Stability"/>
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              </addresses>
              <target>
                <detailString value="White solid"/>
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                <text value="IR spectrum conforms to reference standard"/>
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              <description>
                <text value="pH 3.4-4.3"/>
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                    <valueQuantity>
                      <value value="3.4"/>
                      <comparator value="&gt;="/>
                      <unit value="[pH]"/>
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                      <code value="[pH]"/>
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                      <value value="4.3"/>
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                      <code value="[pH]"/>
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                </modifierExtension>
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            <goal id="fc230a97-fd1a-4017-8603-822c5430a217">
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                <text value="Formaldehyde NMT 1.5%"/>
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                <text value="FTIR"/>
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                  <code value="C204971"/>
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              <documentation>
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            <meta>
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            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf"> </a><p class="res-header-id"><b>Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf</b></p><a name="278736ef-2ddf-49e4-895c-3a9f34db36cf"> </a><a name="hc278736ef-2ddf-49e4-895c-3a9f34db36cf"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-excipient.html">Excipient Drug Substance</a></p></div><p><b>identifier</b>: Cochineal</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><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 TZ8Z31B35M}">TZ8Z31B35M</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>Cochineal</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><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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}">Chemical</span></td><td><span title="Codes:">Dactylopius</span></td><td><span title="Codes:">cochineal</span></td><td><span title="Codes:{urn:iso:std:iso:3166 TUR}">Turkey</span></td></tr></table></div>
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              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><p class="res-header-id"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name="4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="hc4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-cmc-organization.html">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</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>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>
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                      value="Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478"/>
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                <city value="Bridgeport"/>
                <state value="CT"/>
                <postalCode value="65478"/>
                <country value="USA"/>
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