Pharmaceutical Quality (Industry)
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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 - Manufacturing, product - XML Representation

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<Bundle xmlns="http://hl7.org/fhir">
  <!--  Product Manufacturing  -->
  <id value="bundle-product-manufacturing-pq-ex1"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-product-manufacturing-pq"/>
  </meta>
  <type value="collection"/>
  <entry>
    <fullUrl value="urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a"/>
    <resource>
      <PlanDefinition>
        <!-- manufacturingProcess-unlinked -->
        <id value="bf6b038b-1334-3dd4-a552-65c169e2265a"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/PlanDefinition-drug-pq"/>
        </meta>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_bf6b038b-1334-3dd4-a552-65c169e2265a"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="bf6b038b-1334-3dd4-a552-65c169e2265a"> </a><a name="hcbf6b038b-1334-3dd4-a552-65c169e2265a"> </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;bf6b038b-1334-3dd4-a552-65c169e2265a&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-PlanDefinition-drug-pq.html">PlanDefinition - Drug PQ</a></p></div><p><b>Extension - Plan Document Reference PQ</b>: See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb</p><p><b>Extension - History of Process PQ</b>: This can be text about the history</p><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a</code></p><p><b>title</b>: Process 1.0</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>#manufacturing-process &quot;Manufacturing Process&quot;)</span></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 manufacturing process (5)</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-pH</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-test-category.html">Pharmaceutical Test Category Codes</a>#C123456)</span></p><p><b>description</b>: Controls - pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-pq-example.html">Goal Priority - example</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>pH must be in range 6.9 to 7.1 <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>#pH &quot;pH&quot;)</span></td><td>6.9-7.1 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-water-content</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-test-category.html">Pharmaceutical Test Category Codes</a>#C123456)</span></p><p><b>description</b>: Controls - Water Content <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-pq-example.html">Goal Priority - example</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Under 2% <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 &quot;Water content&quot;)</span></td><td>?-2</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>goal-control-particle-size</blockquote><p><b>category</b>: Physical Property <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-test-category.html">Pharmaceutical Test Category Codes</a>#C123456)</span></p><p><b>description</b>: Controls - Particle Size <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>priority</b>: Critical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-goalPriority-pq-example.html">Goal Priority - example</a>#critical)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Measure</b></td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Under 200 microns <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 &quot;Particle Size&quot;)</span></td><td>?-200</td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style="display: none">*</td><td>See on this page: DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d</td><td>Mixing Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-manufacturing-equipment-class.html">Pharmaceutical Manufacturing Equipment Class Codes</a>#mixing-vessel)</span></td></tr></table></blockquote><blockquote><p><b>actor</b></p><h3>Options</h3><table class="grid"><tr><td style="display: none">-</td><td><b>TypeReference</b></td><td><b>Role</b></td></tr><tr><td style="display: none">*</td><td>See on this page: DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d</td><td>Receiving Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-manufacturing-equipment-class.html">Pharmaceutical Manufacturing Equipment Class Codes</a>#receiving-vessel)</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')</p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Capacity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-process-parameter.html">Process Parameter Codes</a>#Capacity)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 750 litres</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>: Temperature <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-process-parameter.html">Process Parameter Codes</a>#TEMP)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 150 °C<span style="background: LightGoldenRodYellow"> (Details: UCUM code Cel = 'Cel')</span></p></blockquote><p><b>prefix</b>: 1</p><p><b>description</b>: Mixing of ingredients</p><p><b>code</b>: Mixing of ingredients <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#Mixing of ingredients)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>ResourceReference</b></td></tr><tr><td style="display: none">*</td><td>specification-of</td><td>See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee</td></tr></table><p><b>goalId</b>: goal-control-pH</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494d</p><p><b>role</b>: Blender <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-manufacturing-equipment-class.html">Pharmaceutical Manufacturing Equipment Class Codes</a>#Blender)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: starting material</span></p><p><b>role</b>: Starting Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#StartingMaterial)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: processing material</span></p><p><b>role</b>: Processing Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#ProcessingMaterial)</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><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')</p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Process temperature must be below 40°C <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-process-parameter.html">Process Parameter Codes</a>#TEMP-MAX &quot;Maximum Temperature&quot;)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 40 °C<span style="background: LightGoldenRodYellow"> (Details: UCUM code Cel = 'Cel')</span></p></blockquote><p><b>prefix</b>: 2</p><p><b>description</b>: Drying using a heater</p><p><b>code</b>: Drying <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#drying)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>ResourceReference</b></td></tr><tr><td style="display: none">*</td><td>specification-of</td><td>See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee</td></tr></table><p><b>goalId</b>: goal-control-water-content</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bbd9494c</p><p><b>role</b>: Dryer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-manufacturing-equipment-class.html">Pharmaceutical Manufacturing Equipment Class Codes</a>#Dryer)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: starting material</span></p><p><b>role</b>: Starting Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#StartingMaterial)</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><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')</p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Rotational Speed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-process-parameter.html">Process Parameter Codes</a>#ROTATIONSPEED)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 2500 rpm</p></blockquote><p><b>prefix</b>: 3</p><p><b>description</b>: Particle Size Reduction by using a rotating impeller</p><p><b>code</b>: Particle Size Reduction <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-step.html">Manufacturing Step Codes</a>#particleSizeReduction)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>ResourceReference</b></td></tr><tr><td style="display: none">*</td><td>specification-of</td><td>See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee</td></tr></table><p><b>goalId</b>: goal-control-particle-size</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: See on this page: DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494c</p><p><b>role</b>: Compression Milling <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-manufacturing-equipment-class.html">Pharmaceutical Manufacturing Equipment Class Codes</a>#Compression Milling)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: starting material</span></p><p><b>role</b>: Starting Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-manufacturing-participant-role.html">Manufacturing Participant Role Codes</a>#StartingMaterial)</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></div>
        </text>
        <extension
                   url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-plan-document-reference-pq">
          <valueReference>
            <!--  Process flow diagram  -->
            <!--  or could be a Binary  -->
            <!-- DocumentReference/documentreference-drug-pq-process-flow-diagram -->
            <reference
                       value="DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb"/>
          </valueReference>
        </extension>
        <extension
                   url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-history-of-process-pq">
          <valueMarkdown value="This can be text about the history"/>
        </extension>
        <!-- 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="Process 1.0"/>
        <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="manufacturing-process"/>
            <display value="Manufacturing Process"/>
          </coding>
        </type>
        <status value="active"/>
        <subjectReference>
          <!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
          <reference
                     value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
        </subjectReference>
        <description
                     value="Narrative description of manufacturing process (5)"/>
        <goal id="goal-control-pH">
          <category>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"/>
              <code value="C123456"/>
              <display value="Physical Property"/>
            </coding>
          </category>
          <!--  this is mandatory, even though we don't really want it  -->
          <description>
            <text value="Controls - pH"/>
          </description>
          <priority>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example"/>
              <code value="critical"/>
              <display value="Critical"/>
            </coding>
          </priority>
          <target>
            <measure>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="pH"/>
                <display value="pH"/>
              </coding>
              <text value="pH must be in range 6.9 to 7.1"/>
            </measure>
            <!-- detailString value="can also be a string" -->
            <detailRange>
              <low>
                <value value="6.9"/>
                <unit value="pH"/>
              </low>
              <high>
                <value value="7.1"/>
                <unit value="pH"/>
              </high>
            </detailRange>
          </target>
        </goal>
        <goal id="goal-control-water-content">
          <category>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"/>
              <code value="C123456"/>
              <display value="Physical Property"/>
            </coding>
          </category>
          <!--  this is mandatory, even though we don't really want it  -->
          <description>
            <text value="Controls - Water Content"/>
          </description>
          <priority>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example"/>
              <code value="critical"/>
              <display value="Critical"/>
            </coding>
          </priority>
          <target>
            <measure>
              <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="Under 2%"/>
            </measure>
            <!-- detailString value="can also be a string" -->
            <detailRange>
              <high>
                <value value="2"/>
                <unit value="%"/>
              </high>
            </detailRange>
          </target>
        </goal>
        <goal id="goal-control-particle-size">
          <category>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/pharmaceutical-test-category"/>
              <code value="C123456"/>
              <display value="Physical Property"/>
            </coding>
          </category>
          <description>
            <text value="Controls - Particle Size"/>
          </description>
          <priority>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-goalPriority-pq-example"/>
              <code value="critical"/>
              <display value="Critical"/>
            </coding>
          </priority>
          <target>
            <measure>
              <coding>
                <system
                        value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq-example"/>
                <code value="particle-size"/>
                <display value="Particle Size"/>
              </coding>
              <text value="Under 200 microns"/>
            </measure>
            <!-- detailString value="can also be a string" -->
            <detailRange>
              <high>
                <value value="200"/>
                <unit value="microns"/>
              </high>
            </detailRange>
          </target>
        </goal>
        <actor>
          <option>
            <typeReference>
              <!-- DeviceDefinition/mixing-vessel -->
              <reference
                         value="DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/pharmaceutical-manufacturing-equipment-class"/>
                <code value="mixing-vessel"/>
                <display value="Mixing Vessel"/>
              </coding>
            </role>
          </option>
        </actor>
        <actor>
          <option>
            <typeReference>
              <!-- DeviceDefinition/receiving-tank -->
              <reference
                         value="DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/pharmaceutical-manufacturing-equipment-class"/>
                <code value="receiving-vessel"/>
                <display value="Receiving Vessel"/>
              </coding>
            </role>
          </option>
        </actor>
        <!--  outer action is the whole thing, if needed  -->
        <!--  step 1 mixing  -->
        <!-- action>
                            <code>
                                <text value="Control"/>
                            </code>
                            <definitionCanonical value="ObservationDefinition/ControlPH"/>
                        </action>
                        <action>
                            <code>
                                <text value="Control"/>
                            </code>
                            <definitionCanonical value="ObservationDefinition/ControlTemperature"/>
                        </action -->
        <action>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq">
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/manufacturing-step-scale"/>
              <code value="PROD"/>
              <display value="Production Scale"/>
            </valueCoding>
          </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="Capacity"/>
                  <display value="Capacity"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <extension url="value">
              <valueQuantity>
                <value value="750"/>
                <unit value="litres"/>
              </valueQuantity>
            </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="TEMP"/>
                  <display value="Temperature"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <extension url="value">
              <valueQuantity>
                <value value="150"/>
                <unit value="°C"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="Cel"/>
              </valueQuantity>
            </extension>
          </extension>
          <prefix value="1"/>
          <description value="Mixing of ingredients"/>
          <code>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
              <code value="Mixing of ingredients"/>
              <display value="Mixing of ingredients"/>
            </coding>
          </code>
          <documentation>
            <type value="specification-of"/>
            <resourceReference>
              <!-- DocumentReference/DocumentReference-image -->
              <reference
                         value="DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee"/>
            </resourceReference>
          </documentation>
          <goalId value="goal-control-pH"/>
          <!-- goalId value="goal-control-temp"/ -->
          <participant>
            <typeReference>
              <!--  this is new in R5 and is not in R4B  -->
              <!-- DeviceDefinition/mixer -->
              <reference
                         value="DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494d"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/pharmaceutical-manufacturing-equipment-class"/>
                <code value="Blender"/>
                <display value="Blender"/>
              </coding>
            </role>
          </participant>
          <participant>
            <!--  added to suppress IG warning about empty reference  -->
            <typeReference>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                <valueReference>
                  <!-- SubstanceDefinition/startingMaterial -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821153"/>
                </valueReference>
              </extension>
              <display value="starting material"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
                <code value="StartingMaterial"/>
                <display value="Starting Material"/>
              </coding>
            </role>
          </participant>
          <participant>
            <!--  added to suppress IG warning about empty reference  -->
            <typeReference>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                <valueReference>
                  <!-- SubstanceDefinition/processingMaterial -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821155"/>
                </valueReference>
              </extension>
              <display value="processing material"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
                <code value="ProcessingMaterial"/>
                <display value="Processing Material"/>
              </coding>
            </role>
          </participant>
          <participant>
            <!--  added to suppress IG warning about empty reference  -->
            <typeReference>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                <valueReference>
                  <!-- SubstanceDefinition/StelbatololAqueousSolution -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821154"/>
                </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>
        <!--  step 2 drying  -->
        <action>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq">
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/manufacturing-step-scale"/>
              <code value="PROD"/>
              <display value="Production Scale"/>
            </valueCoding>
          </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"/>
                  <!--  TODO LOINC?  -->
                  <code value="TEMP-MAX"/>
                  <display value="Maximum Temperature"/>
                </coding>
                <text value="Process temperature must be below 40°C"/>
              </valueCodeableConcept>
            </extension>
            <extension url="value">
              <!--  todo want a range here  -->
              <valueQuantity>
                <value value="40"/>
                <unit value="°C"/>
                <system value="http://unitsofmeasure.org"/>
                <code value="Cel"/>
              </valueQuantity>
            </extension>
          </extension>
          <prefix value="2"/>
          <description value="Drying using a heater"/>
          <!-- text value="Step 2 in the process - free text is possible"/ -->
          <code>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
              <code value="drying"/>
              <display value="Drying"/>
            </coding>
          </code>
          <documentation>
            <type value="specification-of"/>
            <resourceReference>
              <!-- DocumentReference/DocumentReference-image -->
              <reference
                         value="DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee"/>
            </resourceReference>
          </documentation>
          <goalId value="goal-control-water-content"/>
          <participant>
            <typeReference>
              <!--  this is new in R5 and is not in R4B  -->
              <!-- DeviceDefinition/dryer -->
              <reference
                         value="DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bbd9494c"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/pharmaceutical-manufacturing-equipment-class"/>
                <code value="Dryer"/>
                <display value="Dryer"/>
              </coding>
            </role>
          </participant>
          <participant>
            <!--  added to suppress IG warning about empty reference  -->
            <typeReference>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                <valueReference>
                  <!-- SubstanceDefinition/StelbatololAqueousSolution -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821154"/>
                </valueReference>
              </extension>
              <display value="starting material"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
                <code value="StartingMaterial"/>
                <display value="Starting Material"/>
              </coding>
            </role>
          </participant>
          <participant>
            <!--  added to suppress IG warning about empty reference  -->
            <typeReference>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                <valueReference>
                  <!-- SubstanceDefinition/StelbatololGranules -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821113"/>
                </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>
        <!--  step 3 particle size  -->
        <action>
          <extension
                     url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-step-scale-pq">
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/manufacturing-step-scale"/>
              <code value="PROD"/>
              <display value="Production Scale"/>
            </valueCoding>
          </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="ROTATIONSPEED"/>
                  <display value="Rotational Speed"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <extension url="value">
              <valueQuantity>
                <value value="2500"/>
                <unit value="rpm"/>
              </valueQuantity>
            </extension>
          </extension>
          <prefix value="3"/>
          <description
                       value="Particle Size Reduction by using a rotating impeller"/>
          <!-- text value="Step 2 in the process - free text is possible"/ -->
          <code>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/manufacturing-step"/>
              <code value="particleSizeReduction"/>
              <display value="Particle Size Reduction"/>
            </coding>
          </code>
          <documentation>
            <type value="specification-of"/>
            <resourceReference>
              <!-- DocumentReference/DocumentReference-image -->
              <reference
                         value="DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee"/>
            </resourceReference>
          </documentation>
          <goalId value="goal-control-particle-size"/>
          <participant>
            <typeReference>
              <!--  this is new in R5 and is not in R4B  -->
              <!-- DeviceDefinition/devicedefinition-drug-pq-ex1 -->
              <reference
                         value="DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494c"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/pharmaceutical-manufacturing-equipment-class"/>
                <code value="Compression Milling"/>
                <display value="Compression Milling"/>
              </coding>
            </role>
          </participant>
          <participant>
            <!--  added to suppress IG warning about empty reference  -->
            <typeReference>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                <valueReference>
                  <!-- SubstanceDefinition/StelbatololGranules -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821113"/>
                </valueReference>
              </extension>
              <display value="starting material"/>
            </typeReference>
            <role>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/manufacturing-participant-role"/>
                <code value="StartingMaterial"/>
                <display value="Starting Material"/>
              </coding>
            </role>
          </participant>
          <participant>
            <!--  added to suppress IG warning about empty reference  -->
            <typeReference>
              <extension
                         url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
                <valueReference>
                  <!-- SubstanceDefinition/Stelbatolol -->
                  <reference
                             value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"/>
                </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>
      </PlanDefinition>
    </resource>
  </entry>
  <!--  Section 5.2 - Unit Operation/Equipment Information  -->
  <entry>
    <fullUrl value="urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c"/>
    <resource>
      <DeviceDefinition>
        <!-- devicedefinition-drug-pq-ex1 -->
        <id value="82a39a18-91cf-a19d-76c1-a9e8bad9494c"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9494c"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-a19d-76c1-a9e8bad9494c"> </a><a name="hc82a39a18-91cf-a19d-76c1-a9e8bad9494c"> </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-a9e8bad9494c&quot; </p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Rotating Impeller with 1.5mm screen</td><td>registered-name</td></tr></table><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>Maximum Speed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-device-property.html">Device Property Codes</a>#Maximum Speed)</span></td><td>5000 RPM</td></tr></table></div>
        </text>
        <!-- <meta>
                    <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DeviceDefinition-drug-pq"/>
                </meta> -->
        <deviceName>
          <name value="Rotating Impeller with 1.5mm screen"/>
          <type value="registered-name"/>
        </deviceName>
        <property>
          <type>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/device-property"/>
              <code value="Maximum Speed"/>
              <display value="Maximum Speed"/>
            </coding>
          </type>
          <valueQuantity>
            <value value="5000"/>
            <unit value="RPM"/>
          </valueQuantity>
        </property>
      </DeviceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bbd9494c"/>
    <resource>
      <DeviceDefinition>
        <!-- dryer -->
        <id value="82a39a18-91cf-a19d-76c1-a9e8bbd9494c"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bbd9494c"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-a19d-76c1-a9e8bbd9494c"> </a><a name="hc82a39a18-91cf-a19d-76c1-a9e8bbd9494c"> </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-a9e8bbd9494c&quot; </p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Heated dryer</td><td>registered-name</td></tr></table><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>Power <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-device-property.html">Device Property Codes</a>#Power)</span></td><td>3 kW</td></tr></table></div>
        </text>
        <deviceName>
          <name value="Heated dryer"/>
          <type value="registered-name"/>
        </deviceName>
        <property>
          <type>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/device-property"/>
              <code value="Power"/>
              <display value="Power"/>
            </coding>
          </type>
          <valueQuantity>
            <value value="3"/>
            <unit value="kW"/>
          </valueQuantity>
        </property>
      </DeviceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494d"/>
    <resource>
      <DeviceDefinition>
        <!-- mixer -->
        <id value="82a39a18-91cf-a19d-76c1-a9e8bad9494d"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9494d"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-a19d-76c1-a9e8bad9494d"> </a><a name="hc82a39a18-91cf-a19d-76c1-a9e8bad9494d"> </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-a9e8bad9494d&quot; </p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Blender</td><td>registered-name</td></tr></table><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>Maximum capacity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-device-property.html">Device Property Codes</a>#Maximum capacity)</span></td><td>1000 litres</td></tr></table></div>
        </text>
        <deviceName>
          <name value="Blender"/>
          <type value="registered-name"/>
        </deviceName>
        <property>
          <type>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/device-property"/>
              <code value="Maximum capacity"/>
              <display value="Maximum capacity"/>
            </coding>
          </type>
          <valueQuantity>
            <value value="1000"/>
            <unit value="litres"/>
          </valueQuantity>
        </property>
      </DeviceDefinition>
    </resource>
  </entry>
  <!--  Section 5.1 - Manufacturing Process Overview - Process Flow Diagram  -->
  <entry>
    <fullUrl value="urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb"/>
    <resource>
      <DocumentReference>
        <!-- documentreference-drug-pq-process-flow-diagram -->
        <id value="74d4c070-6596-8252-8ad9-afa515a41feb"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_74d4c070-6596-8252-8ad9-afa515a41feb"> </a><p><b>Generated Narrative: DocumentReference</b><a name="74d4c070-6596-8252-8ad9-afa515a41feb"> </a><a name="hc74d4c070-6596-8252-8ad9-afa515a41feb"> </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 DocumentReference &quot;74d4c070-6596-8252-8ad9-afa515a41feb&quot; </p></div><p><b>identifier</b>: <code>http://example.org/fhir/identifier/document</code>/FLOW-001</p><p><b>status</b>: current</p><p><b>type</b>: Process Flow Diagram <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-diagram-type.html">Diagram Type Codes</a>#ProcessFlowDiagram)</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Data</b></td></tr><tr><td style="display: none">*</td><td>image/x-png</td><td>(base64 data - 8838 bytes)</td></tr></table></blockquote></div>
        </text>
        <!-- <meta>
                    <profile value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/DocumentReference-drug-pq"/>       
                </meta> -->
        <identifier>
          <system value="http://example.org/fhir/identifier/document"/>
          <value value="FLOW-001"/>
        </identifier>
        <status value="current"/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/diagram-type"/>
            <code value="ProcessFlowDiagram"/>
            <display value="Process Flow Diagram"/>
          </coding>
        </type>
        <content>
          <attachment>
            <contentType value="image/x-png"/>
            <data
                  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          </attachment>
        </content>
      </DocumentReference>
    </resource>
  </entry>
  <!--  Section 5.1 - Manufacturing Process Overview - Process Flow Diagram  -->
  <entry>
    <fullUrl value="urn:uuid:74d4c070-6596-8252-8ad9-afa515a41fee"/>
    <resource>
      <DocumentReference>
        <!-- DocumentReference-image -->
        <id value="74d4c070-6596-8252-8ad9-afa515a41fee"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DocumentReference_74d4c070-6596-8252-8ad9-afa515a41fee"> </a><p><b>Generated Narrative: DocumentReference</b><a name="74d4c070-6596-8252-8ad9-afa515a41fee"> </a><a name="hc74d4c070-6596-8252-8ad9-afa515a41fee"> </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 DocumentReference &quot;74d4c070-6596-8252-8ad9-afa515a41fee&quot; </p></div><p><b>status</b>: current</p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png">https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png</a></td></tr></table></blockquote></div>
        </text>
        <status value="current"/>
        <content>
          <attachment>
            <url
                 value="https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png"/>
          </attachment>
        </content>
      </DocumentReference>
    </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-dxpq-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-dxpq-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/Stelbatolol -->
              <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>
        <!-- Stelbatolol -->
        <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:c458791f-7cb8-428e-83f7-8a205f821113"/>
    <resource>
      <SubstanceDefinition>
        <!-- StelbatololGranules -->
        <id value="c458791f-7cb8-428e-83f7-8a205f821113"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821113"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-7cb8-428e-83f7-8a205f821113"> </a><a name="hcc458791f-7cb8-428e-83f7-8a205f821113"> </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-83f7-8a205f821113&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html">SubstanceDefinition - Component Substance Drug PQ</a></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 Granules</td></tr></table></div>
        </text>
        <name>
          <name value="Stelbatolol Granules"/>
        </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>
  <entry>
    <fullUrl value="urn:uuid:8d61736c-a6e3-8301-659f-17da402e012a"/>
    <resource>
      <Organization>
        <!-- manufacturerProcessingMaterial -->
        <id value="8d61736c-a6e3-8301-659f-17da402e012a"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_8d61736c-a6e3-8301-659f-17da402e012a"> </a><p><b>Generated Narrative: Organization</b><a name="8d61736c-a6e3-8301-659f-17da402e012a"> </a><a name="hc8d61736c-a6e3-8301-659f-17da402e012a"> </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;8d61736c-a6e3-8301-659f-17da402e012a&quot; </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3010027650</p><p><b>active</b>: true</p><p><b>type</b>: Drug Product Manufacture <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pharmaceutical-organization-type.html">Pharmaceutical Organization Type Codes</a>#drug-product-manufacture)</span></p><p><b>name</b>: AAA Pharmaceutical, 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>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>
        </text>
        <identifier>
          <!--  FDA establishment identifier  -->
          <system value="urn:oid:2.16.840.1.113883.4.82"/>
          <value value="3010027650"/>
        </identifier>
        <active value="true"/>
        <type>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
            <code value="drug-product-manufacture"/>
            <display value="Drug Product Manufacture"/>
          </coding>
        </type>
        <name value="AAA Pharmaceutical, Inc."/>
        <contact>
          <address>
            <line value="681 Main Street"/>
            <city value="Lumberton"/>
            <state value="New Jersey"/>
            <postalCode value="08048"/>
            <country value="USA"/>
          </address>
        </contact>
      </Organization>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153"/>
    <resource>
      <SubstanceDefinition>
        <!-- startingMaterial -->
        <id value="c458791f-7cb8-428e-83f7-8a205f821153"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821153"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-7cb8-428e-83f7-8a205f821153"> </a><a name="hcc458791f-7cb8-428e-83f7-8a205f821153"> </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-83f7-8a205f821153&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>Stelbatosubstance</td></tr></table></div>
        </text>
        <manufacturer>
          <!-- Organization/substance-manufacturer -->
          <reference
                     value="Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d"/>
        </manufacturer>
        <name>
          <name value="Stelbatosubstance"/>
        </name>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154"/>
    <resource>
      <SubstanceDefinition>
        <!-- StelbatololAqueousSolution -->
        <id value="c458791f-7cb8-428e-83f7-8a205f821154"/>
        <meta>
          <profile
                   value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/SubstanceDefinition-component-substance-drug-pq"/>
        </meta>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821154"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-7cb8-428e-83f7-8a205f821154"> </a><a name="hcc458791f-7cb8-428e-83f7-8a205f821154"> </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-83f7-8a205f821154&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-SubstanceDefinition-component-substance-drug-pq.html">SubstanceDefinition - Component Substance Drug PQ</a></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 Aqueous Solution</td></tr></table></div>
        </text>
        <name>
          <name value="Stelbatolol Aqueous Solution"/>
        </name>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155"/>
    <resource>
      <SubstanceDefinition>
        <!-- processingMaterial -->
        <id value="c458791f-7cb8-428e-83f7-8a205f821155"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821155"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-7cb8-428e-83f7-8a205f821155"> </a><a name="hcc458791f-7cb8-428e-83f7-8a205f821155"> </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-83f7-8a205f821155&quot; </p></div><p><b>manufacturer</b>: See on this page: Organization/8d61736c-a6e3-8301-659f-17da402e012a</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>Processohol</td></tr></table></div>
        </text>
        <manufacturer>
          <!-- Organization/manufacturerProcessingMaterial -->
          <reference
                     value="Organization/8d61736c-a6e3-8301-659f-17da402e012a"/>
        </manufacturer>
        <name>
          <name value="Processohol"/>
        </name>
      </SubstanceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:82a39a18-91cf-a29d-76c1-a9e8bad9494d"/>
    <resource>
      <DeviceDefinition>
        <!-- mixing-vessel -->
        <id value="82a39a18-91cf-a29d-76c1-a9e8bad9494d"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_82a39a18-91cf-a29d-76c1-a9e8bad9494d"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-a29d-76c1-a9e8bad9494d"> </a><a name="hc82a39a18-91cf-a29d-76c1-a9e8bad9494d"> </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-a29d-76c1-a9e8bad9494d&quot; </p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Mixing Vessel</td><td>registered-name</td></tr></table><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>Mixing Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-deviceType-pq-example.html">Device Type - example</a>#mixing-vessel)</span></td></tr></table><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>Capacity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-device-property.html">Device Property Codes</a>#Capacity)</span></td><td>1000 litres</td></tr></table></div>
        </text>
        <deviceName>
          <name value="Mixing Vessel"/>
          <type value="registered-name"/>
        </deviceName>
        <classification>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-pq-example"/>
              <code value="mixing-vessel"/>
              <display value="Mixing Vessel"/>
            </coding>
          </type>
        </classification>
        <property>
          <type>
            <!--  seems a little different to "maximum capacity  -->
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/device-property"/>
              <code value="Capacity"/>
              <display value="Capacity"/>
            </coding>
          </type>
          <valueQuantity>
            <value value="1000"/>
            <unit value="litres"/>
          </valueQuantity>
        </property>
      </DeviceDefinition>
    </resource>
  </entry>
  <entry>
    <fullUrl value="urn:uuid:82a39a18-91cf-b29d-76c1-a9e8bad9494d"/>
    <resource>
      <DeviceDefinition>
        <!-- receiving-tank -->
        <id value="82a39a18-91cf-b29d-76c1-a9e8bad9494d"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="DeviceDefinition_82a39a18-91cf-b29d-76c1-a9e8bad9494d"> </a><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-b29d-76c1-a9e8bad9494d"> </a><a name="hc82a39a18-91cf-b29d-76c1-a9e8bad9494d"> </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-b29d-76c1-a9e8bad9494d&quot; </p></div><h3>DeviceNames</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Receiving Tank</td><td>registered-name</td></tr></table><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>Receiving Tank <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-deviceType-pq-example.html">Device Type - example</a>#receiving-tank)</span></td></tr></table><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>Capacity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-device-property.html">Device Property Codes</a>#Capacity)</span></td><td>1200 litres</td></tr></table></div>
        </text>
        <deviceName>
          <name value="Receiving Tank"/>
          <type value="registered-name"/>
        </deviceName>
        <classification>
          <type>
            <coding>
              <system
                      value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceType-pq-example"/>
              <code value="receiving-tank"/>
              <display value="Receiving Tank"/>
            </coding>
          </type>
        </classification>
        <property>
          <type>
            <!--  seems a little different to "maximum capacity  -->
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/device-property"/>
              <code value="Capacity"/>
              <display value="Capacity"/>
            </coding>
          </type>
          <valueQuantity>
            <value value="1200"/>
            <unit value="litres"/>
          </valueQuantity>
        </property>
      </DeviceDefinition>
    </resource>
  </entry>
</Bundle>