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 – Analytical Procedure, substance - XML Representation

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      <!--  Substance Analytical Procedure  -->
    <Bundle xmlns="http://hl7.org/fhir">
      <id value="bundle-analytical-procedure-pq-ex2-sub"/>
      <!--    <id value="substance-analytical-procedure"/> -->
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"/>
      </meta>
      <type value="collection"/>
      <entry>
        <fullUrl value="urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f"/>
        <resource>
          <PlanDefinition>
            <id value="analyticalProcedure"/>
            <text>
              <status value="extensions"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_analyticalProcedure"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="analyticalProcedure"> </a><a name="hcanalyticalProcedure"> </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;analyticalProcedure&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-pharmaceutical-plan-type.html">Pharmaceutical Plan Type Codes</a>#analytical-procedure &quot;Analytical Procedure&quot;)</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152</p><blockquote><p><b>action</b></p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Optical properties <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-process-parameter.html">Process Parameter Codes</a>#OPTICAL)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: Same as for blue light</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Theory <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-process-parameter.html">Process Parameter Codes</a>#THEORY)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: MIE</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Stir Time <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-process-parameter.html">Process Parameter Codes</a>#STIR)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 1 minute</p></blockquote><p><b>title</b>: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Dispersant</span></p><p><b>role</b>: Dispersant <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#dispersant)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Calculation</p><p><b>description</b>: The particle size result is calculated automatically by the instrument software for each sample.</p><p><b>code</b>: Calculation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Reporting</p><p><b>description</b>: Report the average value as per specification</p><p><b>code</b>: Reporting <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></blockquote></div>
            </text>
            <!-- http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f -->
            <url
                 value="http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f"/>
            <title value="Analytical Procedure"/>
            <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://terminology.hl7.org/CodeSystem/pharmaceutical-plan-type"/>
                <code value="analytical-procedure"/>
                <display value="Analytical Procedure"/>
              </coding>
            </type>
            <status value="active"/>
            <subjectReference>
              <!-- SubstanceDefinition/substance1 -->
              <reference
                         value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"/>
            </subjectReference>
            <action>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq">
                <extension url="parameter">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://terminology.hl7.org/CodeSystem/process-parameter"/>
                      <code value="OPTICAL"/>
                      <display value="Optical properties"/>
                    </coding>
                  </valueCodeableConcept>
                </extension>
                <extension url="valueText">
                  <valueString value="Same as for blue light"/>
                </extension>
              </extension>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq">
                <extension url="parameter">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://terminology.hl7.org/CodeSystem/process-parameter"/>
                      <code value="THEORY"/>
                      <display value="Theory"/>
                    </coding>
                  </valueCodeableConcept>
                </extension>
                <extension url="valueText">
                  <valueString value="MIE"/>
                </extension>
              </extension>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq">
                <extension url="parameter">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://terminology.hl7.org/CodeSystem/process-parameter"/>
                      <code value="STIR"/>
                      <display value="Stir Time"/>
                    </coding>
                  </valueCodeableConcept>
                </extension>
                <extension url="value">
                  <!--  todo ucum  -->
                  <valueQuantity>
                    <value value="1"/>
                    <unit value="minute"/>
                  </valueQuantity>
                </extension>
              </extension>
              <title
                     value="Determination of Particle Size of Stelbat by Laser Diffraction (G1112)"/>
              <!--  can have device here or as ObsDef.device  -->
              <participant>
                <typeReference>
                  <extension
                             url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                    <valueReference>
                      <!-- SubstanceDefinition/dispersant -->
                      <reference
                                 value="SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8135565f82"/>
                    </valueReference>
                  </extension>
                  <display value="Dispersant"/>
                </typeReference>
                <role>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
                    <code value="dispersant"/>
                    <display value="Dispersant"/>
                  </coding>
                </role>
              </participant>
              <participant>
                <typeReference>
                  <extension
                             url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                    <valueReference>
                      <!-- SubstanceDefinition/resultingMaterial -->
                      <reference
                                 value="SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
                    </valueReference>
                  </extension>
                  <display value="Resulting material"/>
                </typeReference>
                <role>
                  <coding>
                    <system
                            value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
                    <code value="ResultingMaterial"/>
                    <display value="Resulting Material"/>
                  </coding>
                </role>
              </participant>
              <action>
                <title value="Sample Preparation"/>
                <action>
                  <title value="Instructions"/>
                  <description
                               value="Vortex approximately 30 seconds. Mix briefly by vortexing immediately before use."/>
                </action>
              </action>
              <action>
                <title value="Sample Analysis"/>
                <action>
                  <code>
                    <text value="Test"/>
                  </code>
                  <!-- ObservationDefinition/ParticleSize -->
                  <definitionCanonical
                                       value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
                </action>
              </action>
              <action>
                <title value="Sample Calculation"/>
                <description
                             value="The particle size result is calculated automatically by the instrument software for each sample."/>
                <code>
                  <text value="Calculation"/>
                </code>
              </action>
              <action>
                <title value="Reporting"/>
                <description
                             value="Report the average value as per specification"/>
                <code>
                  <text value="Reporting"/>
                </code>
              </action>
            </action>
          </PlanDefinition>
        </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><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>
            <name>
              <name value="Stelbatolol"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82"/>
        <resource>
          <SubstanceDefinition>
            <!-- dispersant -->
            <id value="9f69ec9c-5fd1-30d2-0790-9e8135565f82"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8135565f82"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="9f69ec9c-5fd1-30d2-0790-9e8135565f82"> </a><a name="hc9f69ec9c-5fd1-30d2-0790-9e8135565f82"> </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;9f69ec9c-5fd1-30d2-0790-9e8135565f82&quot; </p></div><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Shelf life <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>Refer to local laboratory expiration date (may be extended with supporting data) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table><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>0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)</td></tr></table></div>
            </text>
            <property>
              <type>
                <text value="Shelf life"/>
              </type>
              <valueCodeableConcept>
                <text
                      value="Refer to local laboratory expiration date (may be extended with supporting data)"/>
              </valueCodeableConcept>
            </property>
            <name>
              <name value="0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
        <resource>
          <SubstanceDefinition>
            <!-- resultingMaterial -->
            <id value="9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_9f69ec9c-5fd1-30d2-0790-9e8035565f82"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="9f69ec9c-5fd1-30d2-0790-9e8035565f82"> </a><a name="hc9f69ec9c-5fd1-30d2-0790-9e8035565f82"> </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;9f69ec9c-5fd1-30d2-0790-9e8035565f82&quot; </p></div><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>Stelbat in dispersant (approximately 10 mg/mL)</td></tr></table></div>
            </text>
            <name>
              <name value="Stelbat in dispersant (approximately 10 mg/mL)"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
        <resource>
          <ObservationDefinition>
            <!-- ParticleSize -->
            <id value="12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_12e7e672-40a6-4136-3c1f-b8ba6a7d046e"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4136-3c1f-b8ba6a7d046e"> </a><a name="hc12e7e672-40a6-4136-3c1f-b8ba6a7d046e"> </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;12e7e672-40a6-4136-3c1f-b8ba6a7d046e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size</p><p><b>status</b>: active</p><p><b>description</b>: Number of Analyses: 1 replicate for each sample preparation</p><p><b>code</b>:  <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: See on this page: SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</p><p><b>device</b>: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c</p><p><b>hasMember</b>: </p><ul><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</li><li>See on this page: ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</li></ul></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
            <title value="Particle Size"/>
            <status value="active"/>
            <description
                         value="Number of Analyses: 1 replicate for each sample preparation"/>
            <code>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
                <valueCode value="unsupported"/>
              </extension>
            </code>
            <specimen>
              <!-- SpecimenDefinition/specimendefinition -->
              <reference
                         value="SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
            </specimen>
            <device>
              <!-- DeviceDefinition/laser -->
              <reference
                         value="DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c"/>
            </device>
            <hasMember>
              <!-- ObservationDefinition/ParticleSizeObscuration -->
              <reference
                         value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
            </hasMember>
            <hasMember>
              <!-- ObservationDefinition/ParticleRI -->
              <reference
                         value="ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
            </hasMember>
            <hasMember>
              <!-- ObservationDefinition/ParticleSizeRSD -->
              <reference
                         value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
            </hasMember>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
        <resource>
          <ObservationDefinition>
            <!-- ParticleSizeObscuration -->
            <id value="12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4036-3c1f-b8ba6a7d045e"> </a><a name="hc12e7e672-40a6-4036-3c1f-b8ba6a7d045e"> </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;12e7e672-40a6-4036-3c1f-b8ba6a7d045e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Obscuration</p><p><b>status</b>: active</p><p><b>code</b>: Obscuration (%) <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>#Obscuration &quot;Obscuration&quot;)</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>10-30 %</td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
            <title value="Obscuration"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="Obscuration"/>
                <display value="Obscuration"/>
              </coding>
              <text value="Obscuration (%)"/>
            </code>
            <qualifiedValue>
              <range>
                <extension
                           url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq">
                  <valueQuantity>
                    <value value="15"/>
                    <unit value="%"/>
                  </valueQuantity>
                </extension>
                <low>
                  <value value="10"/>
                  <unit value="%"/>
                </low>
                <high>
                  <value value="30"/>
                  <unit value="%"/>
                </high>
              </range>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
        <resource>
          <ObservationDefinition>
            <!-- ParticleRI -->
            <id value="12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_12e7e672-41a6-4036-3c1f-b8ba6a7d045e"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-41a6-4036-3c1f-b8ba6a7d045e"> </a><a name="hc12e7e672-41a6-4036-3c1f-b8ba6a7d045e"> </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;12e7e672-41a6-4036-3c1f-b8ba6a7d045e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Particle refractive index</p><p><b>status</b>: active</p><p><b>code</b>: Particle refractive index <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>#Refractive index &quot;Refractive index&quot;)</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>1.75-1.75</td></tr></table></div>
            </text>
            <!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
            <title value="Particle refractive index"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="Refractive index"/>
                <display value="Refractive index"/>
              </coding>
              <text value="Particle refractive index"/>
            </code>
            <qualifiedValue>
              <range>
                <!--  unitless  -->
                <low>
                  <value value="1.75"/>
                </low>
                <!--  unitless  -->
                <high>
                  <value value="1.75"/>
                </high>
              </range>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
        <resource>
          <ObservationDefinition>
            <!-- ParticleSizeRSD -->
            <id value="12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e"> </a><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4036-3c1f-b8ba6a7d046e"> </a><a name="hc12e7e672-40a6-4036-3c1f-b8ba6a7d046e"> </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;12e7e672-40a6-4036-3c1f-b8ba6a7d046e&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size RSD</p><p><b>status</b>: active</p><p><b>code</b>: Particle Size RSD <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>#Particle Size RSD)</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/12e7e672-40a6-4036-3c1f-b8ba6a7d046e -->
            <url
                 value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
            <title value="Particle Size RSD"/>
            <status value="active"/>
            <code>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="Particle Size RSD"/>
                <display value="Particle Size RSD"/>
              </coding>
              <text value="Particle Size RSD"/>
            </code>
            <qualifiedValue>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
                <valueString
                             value="The %RSD for the D(v, 0.9) must be not more than 15%"/>
              </extension>
            </qualifiedValue>
          </ObservationDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
        <resource>
          <SpecimenDefinition>
            <!-- specimendefinition -->
            <id value="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </a><p><b>Generated Narrative: SpecimenDefinition</b><a name="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </a><a name="hc3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </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 SpecimenDefinition &quot;3a0cde98-4a73-6d67-1dfc-08e3fc9646a2&quot; </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><p><b>description</b>: Number of Preparations: 3</p></div>
            </text>
            <!-- http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 -->
            <url
                 value="http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
            <status value="active"/>
            <description value="Number of Preparations: 3"/>
          </SpecimenDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c"/>
        <resource>
          <DeviceDefinition>
            <!-- laser -->
            <id value="82a39a18-91cf-a19d-76c1-a9e8bad9495c"/>
            <text>
              <status value="generated"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9495c"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-a19d-76c1-a9e8bad9495c"> </a><a name="hc82a39a18-91cf-a19d-76c1-a9e8bad9495c"> </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 DeviceDefinition &quot;82a39a18-91cf-a19d-76c1-a9e8bad9495c&quot; </p></div><p><b>description</b>: Analyzer with disperser and temperature control accessory, or equivalent</p><h3>Classifications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Particle Size Analyzer with Laser Diffraction <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
            </text>
            <description
                         value="Analyzer with disperser and temperature control accessory, or equivalent"/>
            <classification>
              <type>
                <text value="Particle Size Analyzer with Laser Diffraction"/>
              </type>
            </classification>
          </DeviceDefinition>
        </resource>
      </entry>
    </Bundle>