Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

Raw xml | Download



  <!--  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>