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="a2cba634-a481-4b07-9bd4-62c7ada31e1b"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: PlanDefinition</b><a name="a2cba634-a481-4b07-9bd4-62c7ada31e1b"> </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 "a2cba634-a481-4b07-9bd4-62c7ada31e1b" </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/a2cba634-a481-4b07-9bd4-62c7ada31e1b</code></p><p><b>identifier</b>: CitricAcidSpecification</p><p><b>version</b>: 0.1.20</p><p><b>title</b>: Citric acid specification Example</p><p><b>status</b>: active</p><p><b>subject</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-fd84a8b5-9e96-451c-a5c6-097c943eb38a">urn:uuid:fd84a8b5-9e96-451c-a5c6-097c943eb38a</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>9bc2bfdf-c9b1-440a-bafe-89f2674341d4</blockquote><p><b>description</b>: White Solid <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>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</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>White solid <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>59e2c94a-d383-4776-9b00-3b97b0741c9a</blockquote><p><b>description</b>: IR spectrum 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>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</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>IR spectrum 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>a2ed2d13-e96a-4d7b-b825-c69afd334cf7</blockquote><p><b>description</b>: pH 3.4-4.3 <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>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</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>3.4-4.3 pH</td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>e046aab8-b10f-4e13-89e6-bfa869a90b38</blockquote><p><b>description</b>: residue <= 0.21% <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>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C134030)</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>0.21 percent<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48570 = '%')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>fdf5e37f-ae97-48c1-9809-33aebff37199</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Appearance</p><p><b>code</b>: Visual <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>, Description/Appearance <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC20)</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-101</td></tr></table><p><b>goalId</b>: 9bc2bfdf-c9b1-440a-bafe-89f2674341d4</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>f6da4e9e-4954-4fd1-a78a-b297fea64a6f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identification</p><p><b>code</b>: FTIR <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>: Identification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC7)</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-102</td></tr></table><p><b>goalId</b>: 59e2c94a-d383-4776-9b00-3b97b0741c9a</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>a5beeff6-dcc1-4b42-8ea1-76dea4b0da1d</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: pH</p><p><b>code</b>: Visual <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>: pH <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC23)</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-103</td></tr></table><p><b>goalId</b>: a2ed2d13-e96a-4d7b-b825-c69afd334cf7</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>aad4c3ce-985d-45ab-9d00-c2c01ca3813f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residue on Ignition</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">Dummy NCIT Codesystem</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Residue on Ignition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC38)</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>USP <281></td></tr></table><p><b>goalId</b>: e046aab8-b10f-4e13-89e6-bfa869a90b38</p></blockquote></div>
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<value value="CitricAcidSpecification"/>
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<version value="0.1.20"/>
<title value="Citric acid specification Example"/>
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<system
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<text value="White solid"/>
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<goal id="59e2c94a-d383-4776-9b00-3b97b0741c9a">
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<text value="IR spectrum conforms to reference standard"/>
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<detailRange>
<low>
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<valueCodeableConcept>
<coding>
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<display value="NLT (not less than)"/>
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<value value="3.4"/>
<unit value="pH"/>
<system
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<code value="C45997"/>
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<valueCodeableConcept>
<coding>
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<unit value="pH"/>
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<addresses>
<coding>
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<target>
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<unit value="percent"/>
<system
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<valueDecimal value="1"/>
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<prefix value="Single Stage"/>
<title value="Appearance"/>
<code>
<coding>
<system
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<code value="C96103"/>
<display value="Proprietary"/>
</coding>
<text value="Visual"/>
</code>
<reason>
<extension
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<valueInteger value="1"/>
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<coding>
<system
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<code value="TC6"/>
<display value="Organoleptic"/>
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<reason>
<extension
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<code value="SUBC20"/>
<display value="Description/Appearance"/>
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<documentation>
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<label value="EX-TEST-101"/>
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<extension
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<prefix value="Single Stage"/>
<title value="Identification"/>
<code>
<coding>
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<display value="Proprietary"/>
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<text value="FTIR"/>
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<reason>
<extension
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<valueInteger value="1"/>
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<coding>
<system
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<code value="TC7"/>
<display value="Identification"/>
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<documentation>
<type value="documentation"/>
<label value="EX-TEST-102"/>
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<extension
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<prefix value="Single Stage"/>
<title value="pH"/>
<code>
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<text value="Visual"/>
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<coding>
<system
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<code value="TC23"/>
<display value="pH"/>
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<documentation>
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<label value="EX-TEST-103"/>
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<action id="aad4c3ce-985d-45ab-9d00-c2c01ca3813f">
<extension
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<valueDecimal value="4"/>
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<prefix value="Single Stage"/>
<title value="Residue on Ignition"/>
<code>
<coding>
<system
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<code value="C96102"/>
<display value="Compendial"/>
</coding>
<text value="Visual"/>
</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="TC38"/>
<display value="Residue on Ignition"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <281>"/>
</documentation>
<goalId value="e046aab8-b10f-4e13-89e6-bfa869a90b38"/>
</action>
</PlanDefinition>
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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