Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC)
0.1.20 - Build CI
Pharmaceutical Quality Submissions to Food & Drug Administration (PQ/CMC), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.20 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc/ and changes regularly. See the Directory of published versions
| Active as of 2023-12-01 |
<PlanDefinition xmlns="http://hl7.org/fhir">
<id value="5819b223-d3d2-419f-b617-b3a9a3625b89"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
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<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="5819b223-d3d2-419f-b617-b3a9a3625b89"> </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 "5819b223-d3d2-419f-b617-b3a9a3625b89" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-quality-specification.html">Quality Specification</a></p></div><p><b>Specification Type</b>: Raw Materials/Excipients/Intermediates/Reagents <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C133931)</span></p><p><b>StructureDefinition Work Group</b>: brr</p><p><b>url</b>: <code>http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/5819b223-d3d2-419f-b617-b3a9a3625b89</code></p><p><b>identifier</b>: WaterSpecification</p><p><b>version</b>: 0.1.20</p><p><b>title</b>: Water Specification Example</p><p><b>status</b>: active</p><p><b>subject</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-d3a11b25-e160-4688-b807-6383364096fd">urn:uuid:d3a11b25-e160-4688-b807-6383364096fd</a></p><p><b>date</b>: 2023-12-01</p><p><b>publisher</b>: HL7 International / Biomedical Research and Regulation</p><p><b>contact</b>: HL7 International / Biomedical Research and Regulation: <a href="http://www.hl7.org/Special/committees/rcrim">http://www.hl7.org/Special/committees/rcrim</a>,<a href="mailto:brr@lists.HL7.org">brr@lists.HL7.org</a></p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>Workflow Setting (Details: http://terminology.hl7.org/CodeSystem/usage-context-type code workflow = 'Workflow Setting', stated as 'Workflow Setting')</td><td>Not Applicable <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48660)</span></td></tr></table><p><b>jurisdiction</b>: United States of America <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#US)</span></p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>1779ee35-8725-4322-ae82-89ed499f6864</blockquote><p><b>description</b>: <=12 deg <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>12 degrees of rotation<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68667 = 'deg')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>2897e150-8465-48c7-9269-1cda86dc3075</blockquote><p><b>description</b>: Conforms to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Conforms to reference standard <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>9c86ccba-a210-4ce5-9a23-b145d9f123c6</blockquote><p><b>description</b>: Odorless <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>Odorless <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>de0f0d85-5617-4b07-98fc-9976b2dbf216</blockquote><p><b>description</b>: <= 395mg/L <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>addresses</b>: Release <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134029)</span></p><h3>Targets</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Detail[x]</b></td></tr><tr><td style="display: none">*</td><td>395 milligram<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>3668eb6f-797c-4325-8f41-160c951b4adc</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Color degree</p><p><b>code</b>: Colorimetry <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Organoleptic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC6)</span>, Color of solution <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC22)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-201</td></tr></table><p><b>goalId</b>: 1779ee35-8725-4322-ae82-89ed499f6864</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>42cf5de4-2c64-48fc-a4d8-9e74066c36a3</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Turbidity</p><p><b>code</b>: Spectrophotometer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Turbidity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC51)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-202</td></tr></table><p><b>goalId</b>: 2897e150-8465-48c7-9269-1cda86dc3075</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>c552eee7-4dca-4a01-b291-5044d5132cc9</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Smell and taste</p><p><b>code</b>: Smell <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Organoleptic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC6)</span>, Odor <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC21)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-203</td></tr></table><p><b>goalId</b>: 9c86ccba-a210-4ce5-9a23-b145d9f123c6</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>b33b402a-0dc7-4953-a7b8-aa2efeb8434f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Total hardness</p><p><b>code</b>: Titration <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Hardness <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC20)</span></p><h3>Documentations</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Label</b></td></tr><tr><td style="display: none">*</td><td>documentation</td><td>EX-TEST-204</td></tr></table><p><b>goalId</b>: de0f0d85-5617-4b07-98fc-9976b2dbf216</p></blockquote></div>
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<extension
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<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C133931"/>
<display value="Raw Materials/Excipients/Intermediates/Reagents"/>
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<extension
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<url
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<identifier>
<value value="WaterSpecification"/>
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<version value="0.1.20"/>
<title value="Water Specification Example"/>
<status value="active"/>
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<reference value="urn:uuid:d3a11b25-e160-4688-b807-6383364096fd"/>
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<date value="2023-12-01"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/rcrim"/>
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<telecom>
<system value="email"/>
<value value="brr@lists.HL7.org"/>
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<useContext>
<code>
<system
value="http://terminology.hl7.org/CodeSystem/usage-context-type"/>
<code value="workflow"/>
<display value="Workflow Setting"/>
</code>
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48660"/>
<display value="Not Applicable"/>
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<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
</coding>
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<goal id="1779ee35-8725-4322-ae82-89ed499f6864">
<description>
<text value="<=12 deg"/>
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<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
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<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="12"/>
<unit value="degrees of rotation"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C68667"/>
</detailQuantity>
</target>
</goal>
<goal id="2897e150-8465-48c7-9269-1cda86dc3075">
<description>
<text value="Conforms to reference standard"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="Conforms to reference standard"/>
</detailCodeableConcept>
</target>
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<goal id="9c86ccba-a210-4ce5-9a23-b145d9f123c6">
<description>
<text value="Odorless"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48793"/>
<display value="EQ"/>
</coding>
<text value="Odorless"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="de0f0d85-5617-4b07-98fc-9976b2dbf216">
<description>
<text value="<= 395mg/L"/>
</description>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134029"/>
<display value="Release"/>
</coding>
</addresses>
<target>
<detailQuantity>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C61586"/>
<display value="NMT (not more than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="395"/>
<unit value="milligram"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C28253"/>
</detailQuantity>
</target>
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<action id="3668eb6f-797c-4325-8f41-160c951b4adc">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<prefix value="Single Stage"/>
<title value="Color degree"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Colorimetry"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC6"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC22"/>
<display value="Color of solution"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-201"/>
</documentation>
<goalId value="1779ee35-8725-4322-ae82-89ed499f6864"/>
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<action id="42cf5de4-2c64-48fc-a4d8-9e74066c36a3">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<prefix value="Single Stage"/>
<title value="Turbidity"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Spectrophotometer"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC51"/>
<display value="Turbidity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-202"/>
</documentation>
<goalId value="2897e150-8465-48c7-9269-1cda86dc3075"/>
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<action id="c552eee7-4dca-4a01-b291-5044d5132cc9">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<prefix value="Single Stage"/>
<title value="Smell and taste"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Smell"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC6"/>
<display value="Organoleptic"/>
</coding>
</reason>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="2"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="SUBC21"/>
<display value="Odor"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-203"/>
</documentation>
<goalId value="9c86ccba-a210-4ce5-9a23-b145d9f123c6"/>
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<action id="b33b402a-0dc7-4953-a7b8-aa2efeb8434f">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="4"/>
</extension>
<prefix value="Single Stage"/>
<title value="Total hardness"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Titration"/>
</code>
<reason>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
<valueInteger value="1"/>
</extension>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"/>
<code value="TC20"/>
<display value="Hardness"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-204"/>
</documentation>
<goalId value="de0f0d85-5617-4b07-98fc-9976b2dbf216"/>
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IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#0.1.20 based on FHIR 5.0.0. Generated 2024-03-04
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