Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
<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"><p><b>Generated Narrative: PlanDefinition</b><a name="bf6b038b-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 "bf6b038b-1334-3dd4-a552-65c169e2265a" </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>: <a href="#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41feb">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb)</a></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-cs-planType-local-pq.html">CodeSystem - Plan Type</a>#manufacturing-process "Manufacturing Process")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href="#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></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-cs-testCategory-local-pq.html">CodeSystem - Test Category</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-local-pq.html">CodeSystem - Goal Priority</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.html">CodeSystem - Example Local Codes - Drug</a>#pH "pH")</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-cs-testCategory-local-pq.html">CodeSystem - Test Category</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-local-pq.html">CodeSystem - Goal Priority</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.html">CodeSystem - Example Local Codes - Drug</a>#WaterContent "Water content")</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-cs-testCategory-local-pq.html">CodeSystem - Test Category</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-local-pq.html">CodeSystem - Goal Priority</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.html">CodeSystem - Example Local Codes - Drug</a>#particle-size "Particle Size")</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><a href="#DeviceDefinition_82a39a18-91cf-a29d-76c1-a9e8bad9494d">See above (DeviceDefinition/82a39a18-91cf-a29d-76c1-a9e8bad9494d)</a></td><td>Mixing Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-equipmentClass-local-pq.html">CodeSystem - Equipment Class</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><a href="#DeviceDefinition_82a39a18-91cf-b29d-76c1-a9e8bad9494d">See above (DeviceDefinition/82a39a18-91cf-b29d-76c1-a9e8bad9494d)</a></td><td>Receiving Vessel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-equipmentClass-local-pq.html">CodeSystem - Equipment Class</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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq 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-cs-processParameter-local-pq.html">CodeSystem - Process Parameter</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-cs-processParameter-local-pq.html">CodeSystem - Process Parameter</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-cs-manufacturingStep-local-pq.html">CodeSystem - Manufacturing Step</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><a href="#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41fee">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)</a></td></tr></table><p><b>goalId</b>: goal-control-pH</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <a href="#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9494d">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494d)</a></p><p><b>role</b>: Blender <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-equipmentClass-local-pq.html">CodeSystem - Equipment Class</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-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</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-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</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-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq 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-cs-processParameter-local-pq.html">CodeSystem - Process Parameter</a>#TEMP-MAX "Maximum Temperature")</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-cs-manufacturingStep-local-pq.html">CodeSystem - Manufacturing Step</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><a href="#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41fee">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)</a></td></tr></table><p><b>goalId</b>: goal-control-water-content</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <a href="#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bbd9494c">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bbd9494c)</a></p><p><b>role</b>: Dryer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-equipmentClass-local-pq.html">CodeSystem - Equipment Class</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-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</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-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>Extension - Process Step Scale PQ</b>: Production Scale (Details: http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq 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-cs-processParameter-local-pq.html">CodeSystem - Process Parameter</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-cs-manufacturingStep-local-pq.html">CodeSystem - Manufacturing Step</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><a href="#DocumentReference_74d4c070-6596-8252-8ad9-afa515a41fee">See above (DocumentReference/74d4c070-6596-8252-8ad9-afa515a41fee)</a></td></tr></table><p><b>goalId</b>: goal-control-particle-size</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <a href="#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9494c">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9494c)</a></p><p><b>role</b>: Compression Milling <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-equipmentClass-local-pq.html">CodeSystem - Equipment Class</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-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</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-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
<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-local-pq"/>
<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"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
<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-local-pq"/>
<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"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-testCategory-local-pq"/>
<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-local-pq"/>
<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"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq"/>
<!-- 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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStepScale-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingStep-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-equipmentClass-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<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"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-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 "82a39a18-91cf-a19d-76c1-a9e8bad9494c" </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-cs-deviceProperty-local-pq.html">CodeSystem - Device Property</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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq"/>
<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"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-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 "82a39a18-91cf-a19d-76c1-a9e8bbd9494c" </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-cs-deviceProperty-local-pq.html">CodeSystem - Device Property</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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq"/>
<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"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-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 "82a39a18-91cf-a19d-76c1-a9e8bad9494d" </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-cs-deviceProperty-local-pq.html">CodeSystem - Device Property</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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq"/>
<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"><p><b>Generated Narrative: DocumentReference</b><a name="74d4c070-6596-8252-8ad9-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 "74d4c070-6596-8252-8ad9-afa515a41feb" </p></div><p><b>identifier</b>: id: 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-cs-diagramType-local-pq.html">CodeSystem - Diagram Type</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://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-diagramType-local-pq"/>
<code value="ProcessFlowDiagram"/>
<display value="Process Flow Diagram"/>
</coding>
</type>
<content>
<attachment>
<contentType value="image/x-png"/>
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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"><p><b>Generated Narrative: DocumentReference</b><a name="74d4c070-6596-8252-8ad9-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 "74d4c070-6596-8252-8ad9-afa515a41fee" </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"><p><b>Generated Narrative: MedicinalProductDefinition</b><a name="a0694a7a-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 "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </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-local-pq.html">CodeSystem - Product Name Type</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-local-pq"/>
<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"><p><b>Generated Narrative: Ingredient</b><a name="a0694a7a-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 "a0694a7a-aafa-4cbe-8135-c788a9a4d3d6" </p></div><p><b>status</b>: active</p><p><b>for</b>: <a href="#MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5">See above (MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5)</a></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><a href="#SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152">See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)</a></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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-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 "c458791f-7cb8-428e-83f7-8a205f821152" </p></div><p><b>manufacturer</b>: <a href="#Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d">See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)</a></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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-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 "c458791f-7cb8-428e-83f7-8a205f821113" </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"><p><b>Generated Narrative: Organization</b><a name="9fe98cfa-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 "9fe98cfa-9245-8313-0fc5-d15e613b5d6d" </p></div><p><b>identifier</b>: id: 3003040516</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>
<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"><p><b>Generated Narrative: Organization</b><a name="8d61736c-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 "8d61736c-a6e3-8301-659f-17da402e012a" </p></div><p><b>identifier</b>: id: 3010027650</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>
<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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-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 "c458791f-7cb8-428e-83f7-8a205f821153" </p></div><p><b>manufacturer</b>: <a href="#Organization_9fe98cfa-9245-8313-0fc5-d15e613b5d6d">See above (Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d)</a></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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-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 "c458791f-7cb8-428e-83f7-8a205f821154" </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"><p><b>Generated Narrative: SubstanceDefinition</b><a name="c458791f-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 "c458791f-7cb8-428e-83f7-8a205f821155" </p></div><p><b>manufacturer</b>: <a href="#Organization_8d61736c-a6e3-8301-659f-17da402e012a">See above (Organization/8d61736c-a6e3-8301-659f-17da402e012a)</a></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"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-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 "82a39a18-91cf-a29d-76c1-a9e8bad9494d" </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-local-pq.html">CodeSystem - Device Type</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-cs-deviceProperty-local-pq.html">CodeSystem - Device Property</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-local-pq"/>
<code value="mixing-vessel"/>
<display value="Mixing Vessel"/>
</coding>
</type>
</classification>
<property>
<type>
<!-- seems a little different to "maximum capacity -->
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq"/>
<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"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-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 "82a39a18-91cf-b29d-76c1-a9e8bad9494d" </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-local-pq.html">CodeSystem - Device Type</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-cs-deviceProperty-local-pq.html">CodeSystem - Device Property</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-local-pq"/>
<code value="receiving-tank"/>
<display value="Receiving Tank"/>
</coding>
</type>
</classification>
<property>
<type>
<!-- seems a little different to "maximum capacity -->
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-deviceProperty-local-pq"/>
<code value="Capacity"/>
<display value="Capacity"/>
</coding>
</type>
<valueQuantity>
<value value="1200"/>
<unit value="litres"/>
</valueQuantity>
</property>
</DeviceDefinition>
</resource>
</entry>
</Bundle>
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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