Pharmaceutical Quality (Industry)
1.0.0 - STU1

Pharmaceutical Quality (Industry), 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/uv-dx-pq/ and changes regularly. See the Directory of published versions

## : Example: Bundle – Product Specification - XML Representation

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      <!--  Product Specification  -->
    <Bundle xmlns="http://hl7.org/fhir">
      <id value="bundle-drug-product-specification-pq-ex1"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-specification-pq"/>
      </meta>
      <type value="collection"/>
      <entry>
        <fullUrl value="urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a"/>
        <resource>
          <PlanDefinition>
            <!--  <id value="specificationProtocol"/>  -->
            <!-- id value="plandefinition-drug-specification-dxpq-ex1"/ -->
            <id value="plandefinition-drug-pq-ex3-drug-specification"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_plandefinition-drug-pq-ex3-drug-specification"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="plandefinition-drug-pq-ex3-drug-specification"> </a><a name="hcplandefinition-drug-pq-ex3-drug-specification"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource PlanDefinition &quot;plandefinition-drug-pq-ex3-drug-specification&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: SPECIFICATION(S) FOR DRUG PRODUCT</p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><p><b>description</b>: Narrative description of specifications</p><blockquote><p><b>action</b></p><p><b>title</b>: Specification(s) for Drug Product</p><p><b>code</b>: Overall set of actions <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>action</b></p><p><b>title</b>: Release</p><p><b>code</b>: Timing Group <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>timing</b>: Code: Release time</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: End of shelf life</p><p><b>code</b>: Timing Group <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>timing</b>: Code: At end of shelf life</p><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote><blockquote><p><b>action</b></p></blockquote></blockquote></blockquote></div>
            </text>
            <!-- <meta>
                        <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
                    </meta> -->
            <!-- http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a -->
            <url
                 value="http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a"/>
            <title value="SPECIFICATION(S) FOR DRUG PRODUCT"/>
            <status value="active"/>
            <subjectReference>
              <!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
              <reference
                         value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
            </subjectReference>
            <description value="Narrative description of specifications"/>
            <action>
              <!--  this is then entire thing  -->
              <title value="Specification(s) for Drug Product"/>
              <code>
                <text value="Overall set of actions"/>
              </code>
              <action>
                <title value="Release"/>
                <code>
                  <text value="Timing Group"/>
                </code>
                <timingTiming>
                  <code>
                    <text value="Release time"/>
                  </code>
                </timingTiming>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Description -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Identification -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Assay -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Degradation -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Dissolution -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Uniformity -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Microbiological -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/Water -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
                </action>
              </action>
              <action>
                <title value="End of shelf life"/>
                <code>
                  <text value="Timing Group"/>
                </code>
                <timingTiming>
                  <code>
                    <text value="At end of shelf life"/>
                  </code>
                </timingTiming>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/DescriptionEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/IdentificationEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/AssayEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/DegradationEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/DissolutionEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/UniformityEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/MicrobiologicalEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e"/>
                </action>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/WaterEnd -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851"/>
                </action>
              </action>
            </action>
          </PlanDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:77e7020a-270c-6bed-2e55-28e9e942546c"/>
        <resource>
          <ObservationDefinition>
            <!-- Description -->
            <id value="77e7020a-270c-6bed-2e55-28e9e942546c"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_77e7020a-270c-6bed-2e55-28e9e942546c"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="77e7020a-270c-6bed-2e55-28e9e942546c"> </a><a name="hc77e7020a-270c-6bed-2e55-28e9e942546c"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;77e7020a-270c-6bed-2e55-28e9e942546c&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#DESC)</span></p><p><b>method</b>: Visual inspection <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546c"/>
            <title value="Description"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="DESC"/>
                <display value="Description"/>
              </coding>
              <text value="Description"/>
            </code>
            <method>
              <text value="Visual inspection"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString
                             value="An orange film-coated tablet, debossed with 175 on one side"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
        <resource>
          <ObservationDefinition>
            <!-- DescriptionEnd -->
            <id value="d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_d24ce3cd-213d-4935-97cf-8e2dd03721ec"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="d24ce3cd-213d-4935-97cf-8e2dd03721ec"> </a><a name="hcd24ce3cd-213d-4935-97cf-8e2dd03721ec"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;d24ce3cd-213d-4935-97cf-8e2dd03721ec&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec</code></p><p><b>title</b>: Description</p><p><b>status</b>: active</p><p><b>code</b>: Description <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#DESC)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ec"/>
            <title value="Description"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="DESC"/>
                <display value="Description"/>
              </coding>
              <text value="Description"/>
            </code>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="As for release"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
        <resource>
          <ObservationDefinition>
            <!-- Identification -->
            <id value="0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"> </a><a name="hc0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;0d0ef4cf-242c-1cb1-81c4-c41837ee9a12&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#IDT)</span></p><p><b>method</b>: ID by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12"/>
            <title value="Identification"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="IDT"/>
                <display value="Identification"/>
              </coding>
              <text value="Identification"/>
            </code>
            <method>
              <text value="ID by UHPLC"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString
                             value="Consistent with the retention time and UV spectrum of the reference standard"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
        <resource>
          <ObservationDefinition>
            <!-- IdentificationEnd -->
            <id value="f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_f77ba972-5ef8-a178-9a5f-fe7f54da7499"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="f77ba972-5ef8-a178-9a5f-fe7f54da7499"> </a><a name="hcf77ba972-5ef8-a178-9a5f-fe7f54da7499"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;f77ba972-5ef8-a178-9a5f-fe7f54da7499&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499</code></p><p><b>title</b>: Identification</p><p><b>status</b>: active</p><p><b>code</b>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#IDT)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499"/>
            <title value="Identification"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="IDT"/>
                <display value="Identification"/>
              </coding>
              <text value="Identification"/>
            </code>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="As for release"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
        <resource>
          <ObservationDefinition>
            <!-- Assay -->
            <id value="c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_c0f05343-5b98-6073-1a0f-873aaf4f59bc"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="c0f05343-5b98-6073-1a0f-873aaf4f59bc"> </a><a name="hcc0f05343-5b98-6073-1a0f-873aaf4f59bc"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;c0f05343-5b98-6073-1a0f-873aaf4f59bc&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#ASSAY)</span></p><p><b>method</b>: Assay by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bc"/>
            <title value="Assay"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="ASSAY"/>
                <display value="Assay"/>
              </coding>
              <text value="Assay"/>
            </code>
            <method>
              <text value="Assay by UHPLC"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="95% to 105% of label claim"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
        <resource>
          <ObservationDefinition>
            <!-- AssayEnd -->
            <id value="f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"> </a><a name="hcf4a74fd3-876e-38ce-021f-04e5a8fb6a3f"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;f4a74fd3-876e-38ce-021f-04e5a8fb6a3f&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f</code></p><p><b>title</b>: Assay</p><p><b>status</b>: active</p><p><b>code</b>: Assay <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#ASSAY)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3f"/>
            <title value="Assay"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="ASSAY"/>
                <display value="Assay"/>
              </coding>
              <text value="Assay"/>
            </code>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="As for release"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
        <resource>
          <ObservationDefinition>
            <!-- Degradation -->
            <id value="a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_a3d4d23a-800a-684a-6a47-fcfe44e06041"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="a3d4d23a-800a-684a-6a47-fcfe44e06041"> </a><a name="hca3d4d23a-800a-684a-6a47-fcfe44e06041"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;a3d4d23a-800a-684a-6a47-fcfe44e06041&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041</code></p><p><b>title</b>: Degradation Products</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#DGP)</span></p><p><b>method</b>: Degradation products by UHPLC <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.2</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-1.4</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041"/>
            <title value="Degradation Products"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="DGP"/>
                <display value="Degradation Products"/>
              </coding>
            </code>
            <method>
              <text value="Degradation products by UHPLC"/>
            </method>
            <qualifiedValue>
              <appliesTo>
                <!--  could be a code  -->
                <text value="Impurity 1"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.2"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Impurity 2"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.3"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Impurity 3"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.3"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Individual unspecified degradation products"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.2"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Total degradation products"/>
              </appliesTo>
              <range>
                <high>
                  <value value="1.4"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <component>
              <!--  are expected to have a component that says what impurity this one is  -->
              <code>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                  <code value="IMP"/>
                  <display value="Impurity"/>
                </coding>
              </code>
            </component>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:ef72eeb7-211a-3c16-8460-8725ca43584f"/>
        <resource>
          <ObservationDefinition>
            <!-- DegradationEnd -->
            <id value="ef72eeb7-211a-3c16-8460-8725ca43584f"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_ef72eeb7-211a-3c16-8460-8725ca43584f"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="ef72eeb7-211a-3c16-8460-8725ca43584f"> </a><a name="hcef72eeb7-211a-3c16-8460-8725ca43584f"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;ef72eeb7-211a-3c16-8460-8725ca43584f&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f</code></p><p><b>title</b>: Degradation Products</p><p><b>status</b>: active</p><p><b>code</b>: Degradation Products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#DGP)</span></p><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 1 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.8</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 2 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Impurity 3 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-0.4</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Individual unspecified degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><blockquote><p><b>qualifiedValue</b></p><p><b>appliesTo</b>: Total degradation products <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>range</b>: ?-2.3</p></blockquote><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#IMP)</span></td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584f"/>
            <title value="Degradation Products"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="DGP"/>
                <display value="Degradation Products"/>
              </coding>
            </code>
            <qualifiedValue>
              <appliesTo>
                <!--  could be a code  -->
                <text value="Impurity 1"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.8"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Impurity 2"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.4"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Impurity 3"/>
              </appliesTo>
              <range>
                <high>
                  <value value="0.4"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Individual unspecified degradation products"/>
              </appliesTo>
              <range>
                <high>
                  <value value="2.3"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <qualifiedValue>
              <appliesTo>
                <text value="Total degradation products"/>
              </appliesTo>
              <range>
                <high>
                  <value value="2.3"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
            <component>
              <!--  are expected to have a component that says what impurity this one is  -->
              <code>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                  <code value="IMP"/>
                  <display value="Impurity"/>
                </coding>
              </code>
            </component>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:bb11322b-9470-4f13-91b5-c8a5253380eb"/>
        <resource>
          <ObservationDefinition>
            <!-- Dissolution -->
            <id value="bb11322b-9470-4f13-91b5-c8a5253380eb"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_bb11322b-9470-4f13-91b5-c8a5253380eb"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="bb11322b-9470-4f13-91b5-c8a5253380eb"> </a><a name="hcbb11322b-9470-4f13-91b5-c8a5253380eb"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;bb11322b-9470-4f13-91b5-c8a5253380eb&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380eb"/>
            <title value="Dissolution"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="Dissolution"/>
                <display value="Dissolution"/>
              </coding>
              <text value="Dissolution"/>
            </code>
            <method>
              <text value="Apparatus 2 (paddles), UV measurement"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString
                             value="Shall comply with the requirements of the harmonised USP/JP/Ph Eur Q=80% at 30 minutes"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
        <resource>
          <ObservationDefinition>
            <!-- DissolutionEnd -->
            <id value="6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"> </a><a name="hc6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea</code></p><p><b>title</b>: Dissolution</p><p><b>status</b>: active</p><p><b>code</b>: Dissolution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#Dissolution)</span></p><p><b>method</b>: Apparatus 2 (paddles), UV measurement <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45ea"/>
            <title value="Dissolution"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="Dissolution"/>
                <display value="Dissolution"/>
              </coding>
              <text value="Dissolution"/>
            </code>
            <method>
              <text value="Apparatus 2 (paddles), UV measurement"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="As for release"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
        <resource>
          <ObservationDefinition>
            <!-- Water -->
            <id value="6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"> </a><a name="hc6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;6ce8ab6d-55e2-0412-5fb1-ab33763f30b1&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP &lt;921&gt; <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>?-1.0</td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1"/>
            <title value="Water Content"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="WaterContent"/>
                <display value="Water Content"/>
              </coding>
              <text value="Water Content"/>
            </code>
            <method>
              <text value="USP &lt;921&gt;"/>
            </method>
            <qualifiedValue>
              <range>
                <high>
                  <value value="1.0"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:91391017-774b-5c77-93fa-642534278851"/>
        <resource>
          <ObservationDefinition>
            <!-- WaterEnd -->
            <id value="91391017-774b-5c77-93fa-642534278851"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_91391017-774b-5c77-93fa-642534278851"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="91391017-774b-5c77-93fa-642534278851"> </a><a name="hc91391017-774b-5c77-93fa-642534278851"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;91391017-774b-5c77-93fa-642534278851&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851</code></p><p><b>title</b>: Water Content</p><p><b>status</b>: active</p><p><b>code</b>: Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#WaterContent)</span></p><p><b>method</b>: USP &lt;921&gt; <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>?-2.0</td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851"/>
            <title value="Water Content"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="WaterContent"/>
                <display value="Water Content"/>
              </coding>
              <text value="Water Content"/>
            </code>
            <method>
              <text value="USP &lt;921&gt;"/>
            </method>
            <qualifiedValue>
              <range>
                <high>
                  <value value="2.0"/>
                  <unit value="% w/w"/>
                </high>
              </range>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
        <resource>
          <ObservationDefinition>
            <!-- Microbiological -->
            <id value="64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_64972eb3-99ee-7eae-2f63-733e5ae84f71"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="64972eb3-99ee-7eae-2f63-733e5ae84f71"> </a><a name="hc64972eb3-99ee-7eae-2f63-733e5ae84f71"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;64972eb3-99ee-7eae-2f63-733e5ae84f71&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>method</b>: Ph Eur <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71"/>
            <title value="Microbiological"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="Microbiological Quality"/>
                <display value="Microbiological Quality"/>
              </coding>
              <text value="Microbiological Quality"/>
            </code>
            <method>
              <text value="Ph Eur"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString
                             value="Shall comply with the requirements of the Ph Eur"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:e582e504-36ec-3b50-4043-51bf1147124e"/>
        <resource>
          <ObservationDefinition>
            <!-- MicrobiologicalEnd -->
            <id value="e582e504-36ec-3b50-4043-51bf1147124e"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_e582e504-36ec-3b50-4043-51bf1147124e"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="e582e504-36ec-3b50-4043-51bf1147124e"> </a><a name="hce582e504-36ec-3b50-4043-51bf1147124e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;e582e504-36ec-3b50-4043-51bf1147124e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e</code></p><p><b>title</b>: Microbiological</p><p><b>status</b>: active</p><p><b>code</b>: Microbiological Quality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#Microbiological Quality)</span></p><p><b>method</b>: Ph Eur <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124e"/>
            <title value="Microbiological"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="Microbiological Quality"/>
                <display value="Microbiological Quality"/>
              </coding>
              <text value="Microbiological Quality"/>
            </code>
            <method>
              <text value="Ph Eur"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="As for release"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
        <resource>
          <ObservationDefinition>
            <!-- Uniformity -->
            <id value="e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_e7e2fe59-5433-5cc0-84b1-d5f30032790c"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="e7e2fe59-5433-5cc0-84b1-d5f30032790c"> </a><a name="hce7e2fe59-5433-5cc0-84b1-d5f30032790c"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;e7e2fe59-5433-5cc0-84b1-d5f30032790c&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#uniformity-dosage)</span></p><p><b>method</b>: Weight variation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790c"/>
            <title value="Uniformity of dosage"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="uniformity-dosage"/>
                <display value="uniformity of dosage units (by weight)"/>
              </coding>
              <text value="uniformity of dosage units (by weight)"/>
            </code>
            <method>
              <text value="Weight variation"/>
            </method>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString
                             value="Shall comply with the requirements of the harmonised USP/JP/Ph Eur"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
        <resource>
          <ObservationDefinition>
            <!-- UniformityEnd -->
            <id value="43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_43dbc2a3-00c4-6f79-6b11-63768b412aa3"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="43dbc2a3-00c4-6f79-6b11-63768b412aa3"> </a><a name="hc43dbc2a3-00c4-6f79-6b11-63768b412aa3"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition &quot;43dbc2a3-00c4-6f79-6b11-63768b412aa3&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3</code></p><p><b>title</b>: Uniformity of dosage</p><p><b>status</b>: active</p><p><b>code</b>: uniformity of dosage units (by weight) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq-example.html">Example Local Codes - Drug</a>#uniformity-dosage)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3 -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3"/>
            <title value="Uniformity of dosage"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="uniformity-dosage"/>
                <display value="uniformity of dosage units (by weight)"/>
              </coding>
              <text value="uniformity of dosage units (by weight)"/>
            </code>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString value="As for release"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <!--  MedicinalProductDefinition - the main resource in any product scenario  -->
      <entry>
        <fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
        <!--  Section 1.1 - DP Identification  -->
        <resource>
          <MedicinalProductDefinition>
            <!-- medicinalproductdefinition-drug-product-pq-ex1 -->
            <id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a><a name="hca0694a7a-aafa-4cbe-8135-c788a9a4d3d5"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource MedicinalProductDefinition &quot;a0694a7a-aafa-4cbe-8135-c788a9a4d3d5&quot; </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-productNameType-pq-example.html">Product Name Type - example</a>#Proprietary)</span></p><h3>Parts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>20mg</td><td>Strength part <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>
            </text>
            <description value="Textual description of the product"/>
            <combinedPharmaceuticalDoseForm>
              <coding>
                <system value="http://standardterms.edqm.eu"/>
                <code value="10225000"/>
                <display value="Gastro-resistant tablet"/>
              </coding>
            </combinedPharmaceuticalDoseForm>
            <route>
              <coding>
                <system value="http://standardterms.edqm.eu"/>
                <code value="20053000"/>
                <display value="Oral use"/>
              </coding>
            </route>
            <name>
              <productName value="Stelbat Tablets, 20mg"/>
              <type>
                <coding>
                  <system
                          value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example"/>
                  <code value="Proprietary"/>
                  <display value="Proprietary"/>
                </coding>
              </type>
              <part>
                <part value="20mg"/>
                <type>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
                    <code value="StrengthPart"/>
                    <display value="Strength part"/>
                  </coding>
                </type>
              </part>
            </name>
          </MedicinalProductDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"/>
        <resource>
          <Ingredient>
            <!-- productIngredient -->
            <id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Ingredient_a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"> </a><p><b>Generated Narrative: Ingredient</b><a name="a0694a7a-aafa-4cbe-8135-c788a9a4d3d6"> </a><a name="hca0694a7a-aafa-4cbe-8135-c788a9a4d3d6"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Ingredient &quot;a0694a7a-aafa-4cbe-8135-c788a9a4d3d6&quot; </p></div><p><b>status</b>: active</p><p><b>for</b>: See on this page: MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5</p><p><b>role</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-ingredient-role.html">Ingredient Role</a>#100000072072)</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td>See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152</td></tr></table></blockquote></div>
            </text>
            <status value="active"/>
            <for>
              <!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1 -->
              <reference
                         value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
            </for>
            <role>
              <coding>
                <system value="http://hl7.org/fhir/ingredient-role"/>
                <code value="100000072072"/>
                <display value="Active"/>
              </coding>
            </role>
            <substance>
              <code>
                <reference>
                  <!-- SubstanceDefinition/substance1 -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"/>
                </reference>
              </code>
            </substance>
          </Ingredient>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152"/>
        <resource>
          <SubstanceDefinition>
            <!-- substance1 -->
            <id value="c458791f-7cb8-428e-83f7-8a205f821152"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-7cb8-428e-83f7-8a205f821152"> </a><a name="hcc458791f-7cb8-428e-83f7-8a205f821152"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition &quot;c458791f-7cb8-428e-83f7-8a205f821152&quot; </p></div><p><b>manufacturer</b>: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d</p><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol</td></tr></table></div>
            </text>
            <manufacturer>
              <!-- Organization/substance-manufacturer -->
              <reference
                         value="Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d"/>
            </manufacturer>
            <name>
              <name value="Stelbatolol"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d"/>
        <resource>
          <Organization>
            <!-- substance-manufacturer -->
            <id value="9fe98cfa-9245-8313-0fc5-d15e613b5d6d"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d"> </a><p><b>Generated Narrative: Organization</b><a name="9fe98cfa-9245-8313-0fc5-d15e613b5d6d"> </a><a name="hc9fe98cfa-9245-8313-0fc5-d15e613b5d6d"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Organization &quot;9fe98cfa-9245-8313-0fc5-d15e613b5d6d&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: Drug Substance Manufacture <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#drug-substance-manufacture)</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</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>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>
            </text>
            <identifier>
              <!--  FDA establishment identifier  -->
              <system value="urn:oid:2.16.840.1.113883.4.82"/>
              <value value="3003040516"/>
            </identifier>
            <active value="true"/>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
                <code value="drug-substance-manufacture"/>
                <display value="Drug Substance Manufacture"/>
              </coding>
            </type>
            <name value="AAA Molybdenum Products, Inc."/>
            <contact>
              <address>
                <line value="7233 W 116th Pl"/>
                <line value="Ste C"/>
                <city value="Broomfield"/>
                <state value="Colorado"/>
                <postalCode value="80020"/>
                <country value="USA"/>
              </address>
            </contact>
          </Organization>
        </resource>
      </entry>
    </Bundle>