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
| Active as of 2023-11-28 |
<PlanDefinition xmlns="http://hl7.org/fhir">
<id value="ab241f8c-d21e-4382-a70a-52190dbdf07e"/>
<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"><p><b>Generated Narrative: PlanDefinition</b><a name="ab241f8c-d21e-4382-a70a-52190dbdf07e"> </a><a name="hcab241f8c-d21e-4382-a70a-52190dbdf07e"> </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 "ab241f8c-d21e-4382-a70a-52190dbdf07e" </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">PQ-CMC-FDA Temporary Codes</a>#C133931)</span></p><p><b>url</b>: <code>http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e</code></p><p><b>identifier</b>: RawCitricacid, <a href="http://terminology.hl7.org/5.5.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.36.34.5</p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: Raw Material (Carrageenan) Specification Example</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>#C48660 "Not Applicable")</span></p><p><b>status</b>: active</p><p><b>subject</b>: <a href="Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-0efb1188-04f0-44ba-bfe7-ca6169ca8703">urn:uuid:0efb1188-04f0-44ba-bfe7-ca6169ca8703</a></p><p><b>date</b>: 2023-11-28</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><p><b>jurisdiction</b>: United States of America <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/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>e512320e-0ffb-47d9-922a-5415aaa4cb30</blockquote><p><b>description</b>: Viscous upon cooling <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>Viscous upon cooling <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>2c6e465b-4dec-4a09-9dc5-58c480009d27</blockquote><p><b>description</b>: Kappa, iota or lambda <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>Kappa, iota or Lambda <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>c233a5f7-37e2-4b2b-9f04-cf1b25534865</blockquote><p><b>description</b>: Blue, stringy precipitate forms <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>Blue stringy precipitate forms <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>c759888d-1eac-4a12-aa9b-403f395f2c18</blockquote><p><b>description</b>: FTIR matches 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">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>FTIR matches standard <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>66d4035c-633a-49b1-b974-e3171911f44a</blockquote><p><b>description</b>: max 200 cfu/g <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>200 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>95bf9d43-f337-4905-9c50-788b69d00843</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>4e475e2c-c235-4433-b1e4-201a17e45796</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>af4ec6c3-4590-43f7-92e0-c8dae0e76e1f</blockquote><p><b>description</b>: As Reported <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>As Reported <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>b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73</blockquote><p><b>description</b>: As Reported <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>As Reported <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>464f3063-0a4b-4408-9f4a-d6c0b8170097</blockquote><p><b>description</b>: <= 3 ppm <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>3 parts per million<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>03fbc16c-d4d4-40ac-8689-448bda831dac</blockquote><p><b>description</b>: <= 10 ppm <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 parts per million<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C48523 = '[ppm]')</span></td></tr></table></blockquote><blockquote><p><b>goal</b></p><blockquote><p><b>id</b></p>28aba010-126e-4c47-8611-367cdacdd87e</blockquote><p><b>description</b>: As Reported <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>As Reported <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>4b3aa353-3bc7-463f-b4c2-defd041da2c7</blockquote><p><b>description</b>: <= 2.0% <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>2 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>goal</b></p><blockquote><p><b>id</b></p>8125f603-96e7-4f3e-8b13-c15c5870e6e6</blockquote><p><b>description</b>: <30ml H2O @ 25C <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><blockquote><p><b>target</b></p><p><b>detail</b>: 30 mL<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28254 = 'mL')</span></p></blockquote><blockquote><p><b>target</b></p><p><b>detail</b>: 25 degree Celsius<span style="background: LightGoldenRodYellow"> (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C42559 = 'Cel')</span></p></blockquote></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>428fa917-a7d3-4515-9b48-c9366acd673a</blockquote><p><b>Test Order | Stage Sequence Order</b>: 1</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Identification</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>#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-001</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>Identification A</td><td>e512320e-0ffb-47d9-922a-5415aaa4cb30</td></tr><tr><td style="display: none">*</td><td/><td>Identification B</td><td>2c6e465b-4dec-4a09-9dc5-58c480009d27</td></tr><tr><td style="display: none">*</td><td/><td>Identification C</td><td>c233a5f7-37e2-4b2b-9f04-cf1b25534865</td></tr><tr><td style="display: none">*</td><td/><td>Identification D</td><td>c759888d-1eac-4a12-aa9b-403f395f2c18</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>f7cbb73f-4220-4987-b498-c049230091ea</blockquote><p><b>Test Order | Stage Sequence Order</b>: 2</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Microbial Limits</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>#C96103 "Proprietary")</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>EX-TEST-002</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>Total Bacterial Count</td><td>66d4035c-633a-49b1-b974-e3171911f44a</td></tr><tr><td style="display: none">*</td><td/><td>Salmonella</td><td>95bf9d43-f337-4905-9c50-788b69d00843</td></tr><tr><td style="display: none">*</td><td/><td>Escherichia Coli</td><td>4e475e2c-c235-4433-b1e4-201a17e45796</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>f5f8221c-f9ec-4b47-8ec7-90ff44f7388c</blockquote><p><b>Test Order | Stage Sequence Order</b>: 3</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Elemental Impurities</p><p><b>code</b>: UV <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-cmc-ncit-dummy.html">PQ-CMC-FDA Temporary Codes</a>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, elemental impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC98)</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-003</td></tr></table><h3>Actions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Title</b></td><td><b>GoalId</b></td></tr><tr><td style="display: none">*</td><td/><td>Cadmium (Cd)</td><td>af4ec6c3-4590-43f7-92e0-c8dae0e76e1f</td></tr><tr><td style="display: none">*</td><td/><td>Mercury (Hg)</td><td>b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73</td></tr><tr><td style="display: none">*</td><td/><td>Arsenic (As)</td><td>464f3063-0a4b-4408-9f4a-d6c0b8170097</td></tr><tr><td style="display: none">*</td><td/><td>Lead (Pb)</td><td>03fbc16c-d4d4-40ac-8689-448bda831dac</td></tr></table></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>37b44e91-529a-4d87-843b-ec3dd172c09f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 4</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Residual Solvents</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>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</span>, residual solvent <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#SUBC101)</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-004</td></tr></table><p><b>goalId</b>: 28aba010-126e-4c47-8611-367cdacdd87e</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>25a64081-a0c2-4d72-8a48-538f81fcc35f</blockquote><p><b>Test Order | Stage Sequence Order</b>: 5</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Impurity: Insoluble Matter</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>#C96103 "Proprietary")</span></p><p><b>reason</b>: Impurity <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC53)</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-005</td></tr></table><p><b>goalId</b>: 4b3aa353-3bc7-463f-b4c2-defd041da2c7</p></blockquote><blockquote><p><b>action</b></p><blockquote><p><b>id</b></p>055a79d2-3f6b-49ec-a129-6feac5c33812</blockquote><p><b>Test Order | Stage Sequence Order</b>: 6</p><p><b>prefix</b>: Single Stage</p><p><b>title</b>: Solubility in H2O</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>#C96103 "Proprietary")</span></p><p><b>reason</b>: Solubility <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-pqcmc-test-category-codes.html">Hierarchical Test Category Codes</a>#TC24)</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-006</td></tr></table><p><b>goalId</b>: 8125f603-96e7-4f3e-8b13-c15c5870e6e6</p></blockquote></div>
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<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="2"/>
<unit value="percent"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C48570"/>
</detailQuantity>
</target>
</goal>
<goal id="8125f603-96e7-4f3e-8b13-c15c5870e6e6">
<description>
<text value="<30ml H2O @ 25C"/>
</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="C61585"/>
<display value="LT (less than)"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="30"/>
<unit value="mL"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C28254"/>
</detailQuantity>
</target>
<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="C48793"/>
<display value="EQ"/>
</coding>
</valueCodeableConcept>
</extension>
<value value="25"/>
<unit value="degree Celsius"/>
<system
value="http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"/>
<code value="C42559"/>
</detailQuantity>
</target>
</goal>
<action id="428fa917-a7d3-4515-9b48-c9366acd673a">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1"/>
</extension>
<prefix value="Single Stage"/>
<title value="Identification"/>
<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="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="TC7"/>
<display value="Identification"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-001"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.1"/>
</extension>
<title value="Identification A"/>
<goalId value="e512320e-0ffb-47d9-922a-5415aaa4cb30"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.2"/>
</extension>
<title value="Identification B"/>
<goalId value="2c6e465b-4dec-4a09-9dc5-58c480009d27"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.3"/>
</extension>
<title value="Identification C"/>
<goalId value="c233a5f7-37e2-4b2b-9f04-cf1b25534865"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="1.4"/>
</extension>
<title value="Identification D"/>
<goalId value="c759888d-1eac-4a12-aa9b-403f395f2c18"/>
</action>
</action>
<action id="f7cbb73f-4220-4987-b498-c049230091ea">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2"/>
</extension>
<prefix value="Single Stage"/>
<title value="Microbial Limits"/>
<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="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="EX-TEST-002"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2.1"/>
</extension>
<title value="Total Bacterial Count"/>
<goalId value="66d4035c-633a-49b1-b974-e3171911f44a"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2.2"/>
</extension>
<title value="Salmonella"/>
<goalId value="95bf9d43-f337-4905-9c50-788b69d00843"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="2.3"/>
</extension>
<title value="Escherichia Coli"/>
<goalId value="4e475e2c-c235-4433-b1e4-201a17e45796"/>
</action>
</action>
<action id="f5f8221c-f9ec-4b47-8ec7-90ff44f7388c">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3"/>
</extension>
<prefix value="Single Stage"/>
<title value="Elemental Impurities"/>
<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="UV"/>
</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="TC53"/>
<display value="Impurity"/>
</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="SUBC98"/>
<display value="elemental impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-003"/>
</documentation>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3.1"/>
</extension>
<title value="Cadmium (Cd)"/>
<goalId value="af4ec6c3-4590-43f7-92e0-c8dae0e76e1f"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3.2"/>
</extension>
<title value="Mercury (Hg)"/>
<goalId value="b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3.3"/>
</extension>
<title value="Arsenic (As)"/>
<goalId value="464f3063-0a4b-4408-9f4a-d6c0b8170097"/>
</action>
<action>
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="3.4"/>
</extension>
<title value="Lead (Pb)"/>
<goalId value="03fbc16c-d4d4-40ac-8689-448bda831dac"/>
</action>
</action>
<action id="37b44e91-529a-4d87-843b-ec3dd172c09f">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="4"/>
</extension>
<prefix value="Single Stage"/>
<title value="Residual Solvents"/>
<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="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="TC53"/>
<display value="Impurity"/>
</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="SUBC101"/>
<display value="residual solvent"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-004"/>
</documentation>
<goalId value="28aba010-126e-4c47-8611-367cdacdd87e"/>
</action>
<action id="25a64081-a0c2-4d72-8a48-538f81fcc35f">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="5"/>
</extension>
<prefix value="Single Stage"/>
<title value="Impurity: Insoluble Matter"/>
<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="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="TC53"/>
<display value="Impurity"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-005"/>
</documentation>
<goalId value="4b3aa353-3bc7-463f-b4c2-defd041da2c7"/>
</action>
<action id="055a79d2-3f6b-49ec-a129-6feac5c33812">
<extension
url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension">
<valueDecimal value="6"/>
</extension>
<prefix value="Single Stage"/>
<title value="Solubility in H2O"/>
<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="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="TC24"/>
<display value="Solubility"/>
</coding>
</reason>
<documentation>
<type value="documentation"/>
<label value="EX-TEST-006"/>
</documentation>
<goalId value="8125f603-96e7-4f3e-8b13-c15c5870e6e6"/>
</action>
</PlanDefinition>
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
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