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.5.1 Bundle - XML Representation

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    <Bundle xmlns="http://hl7.org/fhir">
      <id value="SpecificationProductBundle"/>
      <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:34a0748d-b199-4a2e-a5bc-0f880886fef7"/>
      </identifier>
      <type value="document"/>
      <timestamp value="2023-12-15T22:33:13.089Z"/>
      <entry>
        <fullUrl value="urn:uuid:d332acdf-4874-407b-9950-528f14c6bea2"/>
        <resource>
          <Composition>
            <id value="d332acdf-4874-407b-9950-528f14c6bea2"/>
            <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_d332acdf-4874-407b-9950-528f14c6bea2"> </a><p class="res-header-id"><b>Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2</b></p><a name="d332acdf-4874-407b-9950-528f14c6bea2"> </a><a name="hcd332acdf-4874-407b-9950-528f14c6bea2"> </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>: ExampleSpecification</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.p.5.1}">m3.2.p.5.1 specification(s)</span></p><p><b>date</b>: 2023-12-15 22:33:13+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>: Quality Specification for an example Drug Product</p></div>
            </text>
            <identifier>
              <value value="ExampleSpecification"/>
            </identifier>
            <status value="final"/>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
                <code value="ich_3.2.p.5.1"/>
                <display value="m3.2.p.5.1 specification(s)"/>
              </coding>
            </type>
            <date value="2023-12-15T22:33:13.089Z"/>
            <author>
              <reference value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
            </author>
            <title value="Quality Specification for an example Drug Product"/>
            <section>
              <title value="32P51"/>
              <entry>
                <reference value="urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7"/>
              </entry>
            </section>
          </Composition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:aa514363-d43f-4052-b44e-b67aa4d6dee7"/>
        <resource>
          <PlanDefinition>
            <id value="aa514363-d43f-4052-b44e-b67aa4d6dee7"/>
            <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_aa514363-d43f-4052-b44e-b67aa4d6dee7"> </a>
    <div>
        <table class="grid dict">

            <tr>
                <th scope="row"><b>Id: </b></th>
                <td style="padding-left: 4px;">aa514363-d43f-4052-b44e-b67aa4d6dee7</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>ExampleSpecification</span>
                    </p>

                </td>
            </tr>

            <tr>
                <th scope="row"><b>Title: </b></th>
                <td style="padding-left: 4px;">Quality Specification for OXAZEPAM</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>C134021</span>
                            </p>

                            <p style="margin-bottom: 5px;">
                                <b>display: </b> <span>Drug Product</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:89676a69-1fe7-422c-ab00-92abe4ef6ea9</span>
                    </p>

                </td>

            </tr>

            <tr>
                <th scope="row"><b>Date: </b></th>
                <td style="padding-left: 4px;">2022-12-08</td>
            </tr>

            <tr>
                <th scope="row"><b>Actions: </b></th>
                <td style="padding-left: 4px;">
                    <table class="grid-dict">

                        <tr>
                            <td>

                                <b>Single Stage Spectrophotometry Identification:</b> <div><p>Alternate</p>
    </div>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Identity - Ferric Chloride:</b> <div><p>Alternate</p>
    </div>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Loss on Drying:</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Readily Carbonizable Sub:</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Residue on ignition (Ash):</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Substances insoluble in sodium carbonate TS:</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Impurities - Chloride (Cl):</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Impurities - Sulfate (SO4):</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Elemental Impurities - Limits:</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Limit of Free Salicylic Acid:</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Organic Volatile Impurities:</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b>Single Stage Assay Dry Basis:</b>

                                <br/>

                            </td>
                        </tr>

                        <tr>
                            <td>

                                <b> Dissolution - 30 minute:</b>

                                <br/>

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

                                    <tr>
                                        <td>

                                            <b>Stage 1 :</b>

                                            <br/>

                                        </td>
                                    </tr>

                                    <tr>
                                        <td>

                                            <b>Stage 2 :</b>

                                            <br/>

                                        </td>
                                    </tr>

                                    <tr>
                                        <td>

                                            <b>Stage 3 :</b>

                                            <br/>

                                        </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="C134011"/>
                  <display value="Not Approved"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <identifier>
              <value value="ExampleSpecification"/>
            </identifier>
            <version value="1.0"/>
            <title value="Quality Specification for OXAZEPAM"/>
            <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="C134021"/>
                <display value="Drug Product"/>
              </coding>
            </type>
            <status value="active"/>
            <subjectReference>
              <reference value="urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
            </subjectReference>
            <date value="2022-12-08"/>
            <goal id="32649771-1290-4386-9cf7-7a72274f22b4">
              <description>
                <text value="Average of 10 between 2-3 pH"/>
              </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="2"/>
                      <comparator value="&gt;="/>
                      <unit value="[pH]"/>
                      <system value="http://unitsofmeasure.org"/>
                      <code value="[pH]"/>
                    </valueQuantity>
                  </extension>
                  <extension url="high">
                    <valueQuantity>
                      <value value="3"/>
                      <comparator value="&lt;"/>
                      <unit value="[pH]"/>
                      <system value="http://unitsofmeasure.org"/>
                      <code value="[pH]"/>
                    </valueQuantity>
                  </extension>
                </modifierExtension>
              </target>
            </goal>
            <goal id="59a4ca76-858e-4d58-8e5f-88e75f51ec33">
              <description>
                <text
                      value="Maxima only at the same wavelengths compared to reference standard"/>
              </description>
              <addresses>
                <coding>
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                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134029"/>
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              <addresses>
                <coding>
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                  <code value="C134030"/>
                  <display value="Stability"/>
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              </addresses>
              <target>
                <detailString value="Conforms"/>
              </target>
            </goal>
            <goal id="c40aa176-e6aa-4fe4-869d-6550ee992903">
              <description>
                <text value="&lt;= 0.5 %"/>
              </description>
              <addresses>
                <coding>
                  <system
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              </addresses>
              <target>
                <detailQuantity>
                  <value value="0.5"/>
                  <comparator value="&lt;="/>
                  <unit value="percent"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="%"/>
                </detailQuantity>
              </target>
            </goal>
            <goal id="b122987d-586c-481b-951c-6202e660158d">
              <description>
                <text value="Color of solution is clear"/>
              </description>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
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              <target>
                <detailString value="Conforms"/>
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            <goal id="929747ad-e83a-46f0-bbbc-133ee951e819">
              <description>
                <text value="&lt;= 0.05 %"/>
              </description>
              <addresses>
                <coding>
                  <system
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              </target>
            </goal>
            <goal id="8d7c85c2-7a4b-432e-ac94-226f296e4fca">
              <description>
                <text value="No Particulate Matter detected"/>
              </description>
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              <target>
                <detailString value="pass"/>
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            <goal id="de4f962a-d486-486d-8d84-f2d1635646b4">
              <description>
                <text value="&lt;= 0.014 %"/>
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                <coding>
                  <system
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            <goal id="b46dce64-a009-46cd-ab95-21d1d5b4df77">
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                <text value="&lt;= 0.04 %"/>
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                  <value value="0.04"/>
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                <text value="&lt;= 0.001 %"/>
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            <goal id="db19e3ab-e28b-4477-8bd7-2409093ed5a3">
              <description>
                <text
                      value="Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution"/>
              </description>
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                <detailString value="pass"/>
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            <goal id="82370588-7aae-4556-9262-a7f50dbd01aa">
              <description>
                <text value="Ethanol &lt; 0.2%"/>
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                  <text value="Ethanol"/>
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                  <value value="0.2"/>
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                <text value="Ethyl Ether &lt; 0.1%"/>
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            <goal id="28ad4d5b-d975-4f6e-9792-b3d9cc7ce279">
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                <text value="1—propanol &lt; 0.15%"/>
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            <goal id="33fa051c-6b3c-4e4d-bd4e-09d39fc253b3">
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                <text value="Total &lt; 0.5%"/>
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              <target>
                <measure>
                  <text value="Total Residual Solvents"/>
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            <goal id="9100e938-42ff-4004-8473-ed5090d66f3a">
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                  <system
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                <extension
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                  <system
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                  <code value="C204845"/>
                  <display value="Active Ingredient Content"/>
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              <goalId value="9100e938-42ff-4004-8473-ed5090d66f3a"/>
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                  <display value="Dissolution"/>
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                <linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
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                <linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
                <prefix value="Stage 2"/>
                <goalId value="47c0d685-0b23-4637-9af8-a554e4fad7ec"/>
                <goalId value="14d3dee8-e024-4367-b0a2-a2a809303ee0"/>
              </action>
              <action>
                <linkId value="6d1ba5a8-6590-496a-ad6b-ca68cfda2878"/>
                <prefix value="Stage 3"/>
                <goalId value="15309a78-92a9-4cf9-aee1-452d6d2f7a91"/>
                <goalId value="666ace1e-bd29-4263-9ae2-2391106326bb"/>
              </action>
            </action>
          </PlanDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
        <resource>
          <MedicinalProductDefinition>
            <id value="89676a69-1fe7-422c-ab00-92abe4ef6ea9"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle"/>
            </meta>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9</b></p><a name="89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </a><a name="hc89676a69-1fe7-422c-ab00-92abe4ef6ea9"> </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-drug-product-handle.html">Drug Product Handle</a></p></div><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25158}">CAPSULE</span></p><p><b>route</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}">ORAL</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</p><p><b>type</b>: <span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: OXAZEPAM</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 30mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">OXAZEPAM</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 60mg</p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}">PROPRANOLOL HYDROCHLORIDE</span></p></blockquote></blockquote></div>
            </text>
            <identifier>
              <value value="Example2BeadDrug"/>
            </identifier>
            <combinedPharmaceuticalDoseForm>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C25158"/>
                <display value="CAPSULE"/>
              </coding>
            </combinedPharmaceuticalDoseForm>
            <route>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C38288"/>
                <display value="ORAL"/>
              </coding>
            </route>
            <name>
              <productName value="OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg"/>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C96971"/>
                  <display value="Nonproprietary Name"/>
                </coding>
                <text value="Non-Proprietary"/>
              </type>
              <part>
                <part value="OXAZEPAM"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="SCI"/>
                  </coding>
                </type>
              </part>
              <part>
                <part value="30mg"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="STR"/>
                  </coding>
                  <text value="OXAZEPAM"/>
                </type>
              </part>
              <part>
                <part value="PROPRANOLOL HYDROCHLORIDE"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="SCI"/>
                  </coding>
                </type>
              </part>
              <part>
                <part value="60mg"/>
                <type>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2"/>
                    <code value="STR"/>
                  </coding>
                  <text value="PROPRANOLOL HYDROCHLORIDE"/>
                </type>
              </part>
            </name>
          </MedicinalProductDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
        <resource>
          <Organization>
            <id value="4f3e9af1-306b-4fad-bf04-7881400b266a"/>
            <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_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>
            </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="143265222"/>
            </identifier>
            <name value="Wunderwerke"/>
            <contact>
              <address>
                <type value="postal"/>
                <text
                      value="Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478"/>
                <line value="123 Scenic Road"/>
                <city value="Bridgeport"/>
                <state value="CT"/>
                <postalCode value="65478"/>
                <country value="USA"/>
              </address>
            </contact>
          </Organization>
        </resource>
      </entry>
    </Bundle>