Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (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">
<id value="6004e36e-7df9-469d-9b29-8e9f9bd7e95f"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"/>
</meta>
<identifier>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version">
<valueString value="0.1.24"/>
</extension>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:3e9cc7a1-e157-4b46-980a-33a8e50dcf65"/>
</identifier>
<type value="document"/>
<timestamp value="2023-12-15T22:36:51.299Z"/>
<entry>
<fullUrl value="urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f"/>
<resource>
<Composition>
<id value="55d92f43-e328-4011-bbcf-744e3afd954f"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Composition_55d92f43-e328-4011-bbcf-744e3afd954f"> </a><p><b>Generated Narrative: Composition</b><a name="55d92f43-e328-4011-bbcf-744e3afd954f"> </a><a name="hc55d92f43-e328-4011-bbcf-744e3afd954f"> </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 Composition "55d92f43-e328-4011-bbcf-744e3afd954f" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ectd-composition-sp4151.html">eCTD Specification Composition</a></p></div><p><b>identifier</b>: ExampleSpecification2</p><p><b>status</b>: final</p><p><b>type</b>: Quality Specification <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-comp-section-types.html">Code System PQCMC Comp Section Types</a>#SP4151)</span></p><p><b>date</b>: 2023-12-15 22:36:51+0000</p><p><b>author</b>: See on this page: urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a</p><p><b>title</b>: Quality Specification for an API</p></div>
</text>
<identifier>
<value value="ExampleSpecification2"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
<code value="SP4151"/>
<display value="Quality Specification"/>
</coding>
</type>
<date value="2023-12-15T22:36:51.299Z"/>
<author>
<reference value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
</author>
<title value="Quality Specification for an API"/>
<section>
<title value="32S41"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"/>
<code value="32S41"/>
<display value="Substance Specification"/>
</coding>
</code>
<entry>
<reference value="urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"/>
</entry>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"/>
<resource>
<PlanDefinition>
<id value="cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"> </a><p><b>Generated Narrative: PlanDefinition</b><a name="cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"> </a><a name="hccc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"> </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 "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-quality-specification.html">Quality Specification</a></p></div><p><b>Specification Type</b>: Drug Substance <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134022)</span></p><p><b>Additional Information</b>: This API is is currently characterized through a standard battery of physicochemical characterzation tests.</p><p><b>identifier</b>: ExampleSpecification2</p><p><b>version</b>: 1.0</p><p><b>title</b>: Quality Specification for an API</p><p><b>type</b>: Workflow Definition <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-plan-definition-type.html">PlanDefinitionType</a>#workflow-definition; <a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134010 "Tentatively Approved")</span></p><p><b>status</b>: active</p><p><b>subject</b>: See on this page: urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf</p><p><b>date</b>: 2022-12-08</p><p><b>approvalDate</b>: 2022-12-08</p><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>b304ed45-5295-4082-9827-f20e1ff0d1d3</blockquote><p><b>description</b>: Negative <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">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</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>Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>d4e38c52-30f6-4bb7-ab84-99439a7266ce</blockquote><p><b>description</b>: Negative <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">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</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>Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>2abf1f19-e1b1-42e4-b943-79f5fa1642fe</blockquote><p><b>description</b>: Negative <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">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</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>Negative <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48793 "EQ")</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>c0ed4a79-8f40-4d26-8845-4cea166fb627</blockquote><p><b>description</b>: NMT 10 colony-forming units <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">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</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>10 colony forming units<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>442983b5-bbc3-4534-9f1b-5ae5e4c531c1</blockquote><p><b>description</b>: NMT 100 colony-forming units <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">PQ-CMC-FDA Temporary Codes</a>#C134029)</span>, Stability <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</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>100 colony forming units<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C68742 = '[CFU]')</span></td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>title</b>: Microbiological Examination of Nonsterile Products</p><p><b>code</b>: Visual <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96102 "Compendial")</span></p><p><b>reason</b>: Microbial Limits <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC13)</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 <61></td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>LinkId</b></td><td><b>Prefix</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 1</td><td>Staphylococcus aureus</td><td>b304ed45-5295-4082-9827-f20e1ff0d1d3</td></tr><tr><td style="display: none">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 2</td><td>Pseudomonas aeruginosa</td><td>d4e38c52-30f6-4bb7-ab84-99439a7266ce</td></tr><tr><td style="display: none">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 3</td><td>Bacillus subtilis</td><td>2abf1f19-e1b1-42e4-b943-79f5fa1642fe</td></tr><tr><td style="display: none">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 4</td><td>Total Aerobic Microbial Count (TAMC)</td><td>c0ed4a79-8f40-4d26-8845-4cea166fb627</td></tr><tr><td style="display: none">*</td><td/><td>997a8ec6-eabf-41a3-b166-ddc3dfb35c27</td><td>Stage 5</td><td>Total Yeasts and Molds Count (TYMC)</td><td>442983b5-bbc3-4534-9f1b-5ae5e4c531c1</td></tr></table></blockquote></div>
</text>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134022"/>
<display value="Drug Substance"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension">
<valueMarkdown
value="This API is is currently characterized through a standard battery of physicochemical characterzation tests."/>
</extension>
<identifier>
<value value="ExampleSpecification2"/>
</identifier>
<version value="1.0"/>
<title value="Quality Specification for an API"/>
<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/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134010"/>
<display value="Tentatively Approved"/>
</coding>
</type>
<status value="active"/>
<subjectReference>
<reference value="urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"/>
</subjectReference>
<date value="2022-12-08"/>
<approvalDate value="2022-12-08"/>
<goal id="b304ed45-5295-4082-9827-f20e1ff0d1d3">
<description>
<text value="Negative"/>
</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>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</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="Negative"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="d4e38c52-30f6-4bb7-ab84-99439a7266ce">
<description>
<text value="Negative"/>
</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>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</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="Negative"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="2abf1f19-e1b1-42e4-b943-79f5fa1642fe">
<description>
<text value="Negative"/>
</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>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</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="Negative"/>
</detailCodeableConcept>
</target>
</goal>
<goal id="c0ed4a79-8f40-4d26-8845-4cea166fb627">
<description>
<text value="NMT 10 colony-forming units"/>
</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>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</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="10"/>
<unit value="colony forming units"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C68742"/>
</detailQuantity>
</target>
</goal>
<goal id="442983b5-bbc3-4534-9f1b-5ae5e4c531c1">
<description>
<text value="NMT 100 colony-forming units"/>
</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>
<addresses>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134030"/>
<display value="Stability"/>
</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="100"/>
<unit value="colony forming units"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C68742"/>
</detailQuantity>
</target>
</goal>
<action id="997a8ec6-eabf-41a3-b166-ddc3dfb35c27">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<title value="Microbiological Examination of Nonsterile Products"/>
<code>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<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="TC13"/>
<display value="Microbial Limits"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="USP <61>"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
<prefix value="Stage 1"/>
<title value="Staphylococcus aureus"/>
<goalId value="b304ed45-5295-4082-9827-f20e1ff0d1d3"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
<prefix value="Stage 2"/>
<title value="Pseudomonas aeruginosa"/>
<goalId value="d4e38c52-30f6-4bb7-ab84-99439a7266ce"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
<prefix value="Stage 3"/>
<title value="Bacillus subtilis"/>
<goalId value="2abf1f19-e1b1-42e4-b943-79f5fa1642fe"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="4"/>
</extension>
<linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
<prefix value="Stage 4"/>
<title value="Total Aerobic Microbial Count (TAMC)"/>
<goalId value="c0ed4a79-8f40-4d26-8845-4cea166fb627"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="5"/>
</extension>
<linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
<prefix value="Stage 5"/>
<title value="Total Yeasts and Molds Count (TYMC)"/>
<goalId value="442983b5-bbc3-4534-9f1b-5ae5e4c531c1"/>
</action>
</action>
</PlanDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"/>
<resource>
<SubstanceDefinition>
<id value="580c28ac-1a2c-49fa-9be3-de997da5edcf"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="SubstanceDefinition_580c28ac-1a2c-49fa-9be3-de997da5edcf"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name="580c28ac-1a2c-49fa-9be3-de997da5edcf"> </a><a name="hc580c28ac-1a2c-49fa-9be3-de997da5edcf"> </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 "580c28ac-1a2c-49fa-9be3-de997da5edcf" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-pqcmc-routine-drug-substance.html">Routine Drug Substance</a></p></div><p><b>identifier</b>: P-Isobutylhydratropic Acid</p><p><b>classification</b>: Chemical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C48807)</span></p><p><b>grade</b>: USP-NF <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C134006)</span></p><p><b>manufacturer</b>: See on this page: urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5</p><p><b>supplier</b>: See on this page: urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</p><h3>Codes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td>WK2XYI10QM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-UNII.html">Unique Ingredient Identifier (UNII)</a>#WK2XYI10QM)</span></td></tr></table><h3>Names</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style="display: none">*</td><td>IBUPROFENPIRIN</td><td>GSRS Preferred Term <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C203355)</span></td><td>true</td></tr></table></div>
</text>
<identifier>
<value value="P-Isobutylhydratropic Acid"/>
</identifier>
<classification>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48807"/>
<display value="Chemical"/>
</coding>
</classification>
<grade>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134006"/>
<display value="USP-NF"/>
</coding>
</grade>
<manufacturer>
<reference value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
</manufacturer>
<supplier>
<reference value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
</supplier>
<code>
<code>
<coding>
<system value="http://fdasis.nlm.nih.gov"/>
<code value="WK2XYI10QM"/>
</coding>
</code>
</code>
<name>
<name value="IBUPROFENPIRIN"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C203355"/>
<display value="GSRS Preferred Term"/>
</coding>
</type>
<preferred value="true"/>
</name>
</SubstanceDefinition>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
<resource>
<Organization>
<id value="4f3e9af1-306b-4fad-bf04-7881400b266a"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><p><b>Generated Narrative: Organization</b><a name="4f3e9af1-306b-4fad-bf04-7881400b266a"> </a><a name="hc4f3e9af1-306b-4fad-bf04-7881400b266a"> </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 "4f3e9af1-306b-4fad-bf04-7881400b266a" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-cmc-sponsor-organization.html">Sponsor Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</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>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<name value="Wunderwerke"/>
<contact>
<address>
<text
value="Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478"/>
<line value="123 Scenic Road"/>
<city value="Bridgeport"/>
<state value="CT"/>
<postalCode value="65478"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
<resource>
<Organization>
<id value="e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </a><p><b>Generated Narrative: Organization</b><a name="e99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </a><a name="hce99bddfa-c1b5-435b-bbe8-24816b4e23e5"> </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 "e99bddfa-c1b5-435b-bbe8-24816b4e23e5" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-mfg-test-site-organization.html">Manufacturing and/or Test Site Organization</a></p></div><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: Vidinaid</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>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="143265222"/>
</identifier>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134004"/>
<display value="FEI"/>
</coding>
</type>
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="6981397"/>
</identifier>
<name value="Vidinaid"/>
<contact>
<address>
<text
value="Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA"/>
<line value="100 Stillwater Avenue"/>
<line value="Building #2"/>
<city value="Bangor"/>
<state value="ME"/>
<postalCode value="04401"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
<resource>
<Organization>
<id value="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
<meta>
<profile
value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><p><b>Generated Narrative: Organization</b><a name="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </a><a name="hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049"> </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 "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-supplier-organization.html">Supplier Organization</a></p></div><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</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>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>
</text>
<identifier>
<type>
<coding>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C134003"/>
<display value="DUNS"/>
</coding>
</type>
<system value="urn:oid:1.3.6.1.4.1.519.1"/>
<value value="173265332"/>
</identifier>
<name value="Mega Chem Supply"/>
<contact>
<address>
<text
value="Mega Chem Supply, 350 W Main Street, Rochester, NY, United States"/>
<line value="350 W Main Street"/>
<city value="Rochester"/>
<state value="NY"/>
<postalCode value="14608"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
</Bundle>
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change