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
<!-- Substance Analytical Procedure -->
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundle-analytical-procedure-pq-ex2-sub"/>
<!-- <id value="substance-analytical-procedure"/> -->
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-analytical-procedure-pq"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f"/>
<resource>
<PlanDefinition>
<id value="analyticalProcedure"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="analyticalProcedure"> </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 "analyticalProcedure" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f</code></p><p><b>title</b>: Analytical Procedure</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cs-planType-local-pq.html">CodeSystem - Plan Type</a>#analytical-procedure "Analytical Procedure")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href="#SubstanceDefinition_c458791f-7cb8-428e-83f7-8a205f821152">See above (SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152)</a></p><blockquote><p><b>action</b></p><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Optical properties <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-processParameter-local-pq.html">CodeSystem - Process Parameter</a>#OPTICAL)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: Same as for blue light</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Theory <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-processParameter-local-pq.html">CodeSystem - Process Parameter</a>#THEORY)</span></p><blockquote><p><b>url</b></p><code>valueText</code></blockquote><p><b>value</b>: MIE</p></blockquote><blockquote><p><b>Extension - Process Parameters PQ</b></p><blockquote><p><b>url</b></p><code>parameter</code></blockquote><p><b>value</b>: Stir Time <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-processParameter-local-pq.html">CodeSystem - Process Parameter</a>#STIR)</span></p><blockquote><p><b>url</b></p><code>value</code></blockquote><p><b>value</b>: 1 minute</p></blockquote><p><b>title</b>: Determination of Particle Size of Stelbat by Laser Diffraction (G1112)</p><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Dispersant</span></p><p><b>role</b>: Dispersant <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</a>#dispersant)</span></p></blockquote><blockquote><p><b>participant</b></p><p><b>typeReference</b>: <span>: Resulting material</span></p><p><b>role</b>: Resulting Material <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-manufacturingParticipantRole-local-pq.html">CodeSystem - Manufacturing Participant Role</a>#ResultingMaterial)</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Preparation</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Analysis</p><blockquote><p><b>action</b></p></blockquote></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Sample Calculation</p><p><b>description</b>: The particle size result is calculated automatically by the instrument software for each sample.</p><p><b>code</b>: Calculation <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>action</b></p><p><b>title</b>: Reporting</p><p><b>description</b>: Report the average value as per specification</p><p><b>code</b>: Reporting <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></blockquote></div>
</text>
<!-- http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f -->
<url
value="http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763f"/>
<title value="Analytical Procedure"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
<code value="workflow-definition"/>
<display value="Workflow Definition"/>
</coding>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-planType-local-pq"/>
<code value="analytical-procedure"/>
<display value="Analytical Procedure"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<!-- SubstanceDefinition/substance1 -->
<reference
value="SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152"/>
</subjectReference>
<action>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq">
<extension url="parameter">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq"/>
<code value="OPTICAL"/>
<display value="Optical properties"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="valueText">
<valueString value="Same as for blue light"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq">
<extension url="parameter">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq"/>
<code value="THEORY"/>
<display value="Theory"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="valueText">
<valueString value="MIE"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-process-parameters-pq">
<extension url="parameter">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-processParameter-local-pq"/>
<code value="STIR"/>
<display value="Stir Time"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="value">
<!-- todo ucum -->
<valueQuantity>
<value value="1"/>
<unit value="minute"/>
</valueQuantity>
</extension>
</extension>
<title
value="Determination of Particle Size of Stelbat by Laser Diffraction (G1112)"/>
<!-- can have device here or as ObsDef.device -->
<participant>
<typeReference>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
<valueReference>
<!-- SubstanceDefinition/dispersant -->
<reference
value="SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8135565f82"/>
</valueReference>
</extension>
<display value="Dispersant"/>
</typeReference>
<role>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<code value="dispersant"/>
<display value="Dispersant"/>
</coding>
</role>
</participant>
<participant>
<typeReference>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-participant-pq">
<valueReference>
<!-- SubstanceDefinition/resultingMaterial -->
<reference
value="SubstanceDefinition/9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
</valueReference>
</extension>
<display value="Resulting material"/>
</typeReference>
<role>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-manufacturingParticipantRole-local-pq"/>
<code value="ResultingMaterial"/>
<display value="Resulting Material"/>
</coding>
</role>
</participant>
<action>
<title value="Sample Preparation"/>
<action>
<title value="Instructions"/>
<description
value="Vortex approximately 30 seconds. Mix briefly by vortexing immediately before use."/>
</action>
</action>
<action>
<title value="Sample Analysis"/>
<action>
<code>
<text value="Test"/>
</code>
<!-- ObservationDefinition/ParticleSize -->
<definitionCanonical
value="ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
</action>
</action>
<action>
<title value="Sample Calculation"/>
<description
value="The particle size result is calculated automatically by the instrument software for each sample."/>
<code>
<text value="Calculation"/>
</code>
</action>
<action>
<title value="Reporting"/>
<description
value="Report the average value as per specification"/>
<code>
<text value="Reporting"/>
</code>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152"/>
<resource>
<SubstanceDefinition>
<!-- substance1 -->
<id value="c458791f-7cb8-428e-83f7-8a205f821152"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><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><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbatolol</td></tr></table></div>
</text>
<name>
<name value="Stelbatolol"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8135565f82"/>
<resource>
<SubstanceDefinition>
<!-- dispersant -->
<id value="9f69ec9c-5fd1-30d2-0790-9e8135565f82"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="9f69ec9c-5fd1-30d2-0790-9e8135565f82"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8135565f82" </p></div><h3>Properties</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Shelf life <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>Refer to local laboratory expiration date (may be extended with supporting data) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)</td></tr></table></div>
</text>
<property>
<type>
<text value="Shelf life"/>
</type>
<valueCodeableConcept>
<text
value="Refer to local laboratory expiration date (may be extended with supporting data)"/>
</valueCodeableConcept>
</property>
<name>
<name value="0.1% Sorbitan monooleate (Span 80) in hexanes (m/v)"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
<resource>
<SubstanceDefinition>
<!-- resultingMaterial -->
<id value="9f69ec9c-5fd1-30d2-0790-9e8035565f82"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SubstanceDefinition</b><a name="9f69ec9c-5fd1-30d2-0790-9e8035565f82"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SubstanceDefinition "9f69ec9c-5fd1-30d2-0790-9e8035565f82" </p></div><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td></tr><tr><td style="display: none">*</td><td>Stelbat in dispersant (approximately 10 mg/mL)</td></tr></table></div>
</text>
<name>
<name value="Stelbat in dispersant (approximately 10 mg/mL)"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
<resource>
<ObservationDefinition>
<!-- ParticleSize -->
<id value="12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4136-3c1f-b8ba6a7d046e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "12e7e672-40a6-4136-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size</p><p><b>status</b>: active</p><p><b>description</b>: Number of Analyses: 1 replicate for each sample preparation</p><p><b>code</b>: <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>specimen</b>: <a href="#SpecimenDefinition_3a0cde98-4a73-6d67-1dfc-08e3fc9646a2">See above (SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2)</a></p><p><b>device</b>: <a href="#DeviceDefinition_82a39a18-91cf-a19d-76c1-a9e8bad9495c">See above (DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c)</a></p><p><b>hasMember</b>: </p><ul><li><a href="#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e)</a></li><li><a href="#ObservationDefinition_12e7e672-41a6-4036-3c1f-b8ba6a7d045e">See above (ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e)</a></li><li><a href="#ObservationDefinition_12e7e672-40a6-4036-3c1f-b8ba6a7d046e">See above (ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e)</a></li></ul></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4136-3c1f-b8ba6a7d046e"/>
<title value="Particle Size"/>
<status value="active"/>
<description
value="Number of Analyses: 1 replicate for each sample preparation"/>
<code>
<extension
url="http://hl7.org/fhir/StructureDefinition/data-absent-reason">
<valueCode value="unsupported"/>
</extension>
</code>
<specimen>
<!-- SpecimenDefinition/specimendefinition -->
<reference
value="SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
</specimen>
<device>
<!-- DeviceDefinition/laser -->
<reference
value="DeviceDefinition/82a39a18-91cf-a19d-76c1-a9e8bad9495c"/>
</device>
<hasMember>
<!-- ObservationDefinition/ParticleSizeObscuration -->
<reference
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/ParticleRI -->
<reference
value="ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
</hasMember>
<hasMember>
<!-- ObservationDefinition/ParticleSizeRSD -->
<reference
value="ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
</hasMember>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<resource>
<ObservationDefinition>
<!-- ParticleSizeObscuration -->
<id value="12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4036-3c1f-b8ba6a7d045e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Obscuration</p><p><b>status</b>: active</p><p><b>code</b>: Obscuration (%) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Obscuration "Obscuration")</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>10-30 %</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d045e"/>
<title value="Obscuration"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Obscuration"/>
<display value="Obscuration"/>
</coding>
<text value="Obscuration (%)"/>
</code>
<qualifiedValue>
<range>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-target-pq">
<valueQuantity>
<value value="15"/>
<unit value="%"/>
</valueQuantity>
</extension>
<low>
<value value="10"/>
<unit value="%"/>
</low>
<high>
<value value="30"/>
<unit value="%"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
<resource>
<ObservationDefinition>
<!-- ParticleRI -->
<id value="12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-41a6-4036-3c1f-b8ba6a7d045e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "12e7e672-41a6-4036-3c1f-b8ba6a7d045e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e</code></p><p><b>title</b>: Particle refractive index</p><p><b>status</b>: active</p><p><b>code</b>: Particle refractive index <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Refractive index "Refractive index")</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Range</b></td></tr><tr><td style="display: none">*</td><td>1.75-1.75</td></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-41a6-4036-3c1f-b8ba6a7d045e"/>
<title value="Particle refractive index"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Refractive index"/>
<display value="Refractive index"/>
</coding>
<text value="Particle refractive index"/>
</code>
<qualifiedValue>
<range>
<!-- unitless -->
<low>
<value value="1.75"/>
</low>
<!-- unitless -->
<high>
<value value="1.75"/>
</high>
</range>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
<resource>
<ObservationDefinition>
<!-- ParticleSizeRSD -->
<id value="12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: ObservationDefinition</b><a name="12e7e672-40a6-4036-3c1f-b8ba6a7d046e"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource ObservationDefinition "12e7e672-40a6-4036-3c1f-b8ba6a7d046e" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e</code></p><p><b>title</b>: Particle Size RSD</p><p><b>status</b>: active</p><p><b>code</b>: Particle Size RSD <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cs-local-codes-drug-pq.html">CodeSystem - Example Local Codes - Drug</a>#Particle Size RSD)</span></p><h3>QualifiedValues</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td></tr><tr><td style="display: none">*</td><td/></tr></table></div>
</text>
<!-- http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e -->
<url
value="http://example-server.com/fhir/ObservationDefinition/12e7e672-40a6-4036-3c1f-b8ba6a7d046e"/>
<title value="Particle Size RSD"/>
<status value="active"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-local-codes-drug-pq"/>
<code value="Particle Size RSD"/>
<display value="Particle Size RSD"/>
</coding>
<text value="Particle Size RSD"/>
</code>
<qualifiedValue>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-qualified-value-text-pq">
<valueString
value="The %RSD for the D(v, 0.9) must be not more than 15%"/>
</extension>
</qualifiedValue>
</ObservationDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<resource>
<SpecimenDefinition>
<!-- specimendefinition -->
<id value="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: SpecimenDefinition</b><a name="3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource SpecimenDefinition "3a0cde98-4a73-6d67-1dfc-08e3fc9646a2" </p></div><p><b>url</b>: <code>http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2</code></p><p><b>status</b>: active</p><p><b>description</b>: Number of Preparations: 3</p></div>
</text>
<!-- http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2 -->
<url
value="http://example-server.com/fhir/SpecimenDefinition/3a0cde98-4a73-6d67-1dfc-08e3fc9646a2"/>
<status value="active"/>
<description value="Number of Preparations: 3"/>
</SpecimenDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9495c"/>
<resource>
<DeviceDefinition>
<!-- laser -->
<id value="82a39a18-91cf-a19d-76c1-a9e8bad9495c"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: DeviceDefinition</b><a name="82a39a18-91cf-a19d-76c1-a9e8bad9495c"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9495c" </p></div><p><b>description</b>: Analyzer with disperser and temperature control accessory, or equivalent</p><h3>Classifications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td>Particle Size Analyzer with Laser Diffraction <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></div>
</text>
<description
value="Analyzer with disperser and temperature control accessory, or equivalent"/>
<classification>
<type>
<text value="Particle Size Analyzer with Laser Diffraction"/>
</type>
</classification>
</DeviceDefinition>
</resource>
</entry>
</Bundle>
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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