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 2023-11-28 |
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:PlanDefinition ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "ab241f8c-d21e-4382-a70a-52190dbdf07e"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: PlanDefinition</b><a name=\"ab241f8c-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\">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/ab241f8c-d21e-4382-a70a-52190dbdf07e</code></p><p><b>identifier</b>: RawCitricacid</p><p><b>version</b>: 0.1.20</p><p><b>title</b>: Raw Material (Carrageenan) Specification Example</p><p><b>status</b>: active</p><p><b>subject</b>: <a href=\"Bundle-7ce2088d-d281-4e2f-9a25-120a1f9805d1.html#urn-uuid-d8242262-2187-4ea2-907f-b66752202b46\">urn:uuid:d8242262-2187-4ea2-907f-b66752202b46</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><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>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\">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>Viscous upon cooling <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>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\">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>Kappa, iota or Lambda <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>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\">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>Blue stringy precipitate forms <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>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\">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>FTIR matches 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>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\">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>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\">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>Negative <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>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\">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>Negative <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>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\">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>As Reported <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>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\">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>As Reported <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>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\">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 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\">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>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\">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>As Reported <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>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\">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>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\">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><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\">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-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\">Dummy NCIT Codesystem</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\">Dummy NCIT Codesystem</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\">Dummy NCIT Codesystem</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\">Dummy NCIT Codesystem</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\">Dummy NCIT Codesystem</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>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-type-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C133931" ] ; fhir:display [ fhir:v "Raw Materials/Excipients/Intermediates/Reagents" ] ] ) ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ fhir:v "brr" ] ] ) ; # fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/PlanDefinition/ab241f8c-d21e-4382-a70a-52190dbdf07e"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:value [ fhir:v "RawCitricacid" ] ] ) ; # fhir:version [ fhir:v "0.1.20"] ; # fhir:title [ fhir:v "Raw Material (Carrageenan) Specification Example"] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "urn:uuid:d8242262-2187-4ea2-907f-b66752202b46" ] ] ; # fhir:date [ fhir:v "2023-11-28"^^xsd:date] ; # fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # fhir:contact ( [ fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ; ( fhir:telecom [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "brr@lists.HL7.org" ] ] ) ] ) ; # fhir:useContext ( [ fhir:code [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/usage-context-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "workflow" ] ; fhir:display [ fhir:v "Workflow Setting" ] ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48660" ] ; fhir:display [ fhir:v "Not Applicable" ] ] ) ] ] ) ; # fhir:jurisdiction ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "US" ] ; fhir:display [ fhir:v "United States of America" ] ] ) ] ) ; # fhir:goal ( [ fhir:id [ fhir:v "e512320e-0ffb-47d9-922a-5415aaa4cb30" ] ; fhir:description [ fhir:text [ fhir:v "Viscous upon cooling" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "Viscous upon cooling" ] ] ] ) ] [ fhir:id [ fhir:v "2c6e465b-4dec-4a09-9dc5-58c480009d27" ] ; fhir:description [ fhir:text [ fhir:v "Kappa, iota or lambda" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "Kappa, iota or Lambda" ] ] ] ) ] [ fhir:id [ fhir:v "c233a5f7-37e2-4b2b-9f04-cf1b25534865" ] ; fhir:description [ fhir:text [ fhir:v "Blue, stringy precipitate forms" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "Blue stringy precipitate forms" ] ] ] ) ] [ fhir:id [ fhir:v "c759888d-1eac-4a12-aa9b-403f395f2c18" ] ; fhir:description [ fhir:text [ fhir:v "FTIR matches standard" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "FTIR matches standard" ] ] ] ) ] [ fhir:id [ fhir:v "66d4035c-633a-49b1-b974-e3171911f44a" ] ; fhir:description [ fhir:text [ fhir:v "max 200 cfu/g" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "200"^^xsd:decimal ] ; fhir:unit [ fhir:v "colony forming units" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C68742" ] ] ] ) ] [ fhir:id [ fhir:v "95bf9d43-f337-4905-9c50-788b69d00843" ] ; fhir:description [ fhir:text [ fhir:v "Negative" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "Negative" ] ] ] ) ] [ fhir:id [ fhir:v "4e475e2c-c235-4433-b1e4-201a17e45796" ] ; fhir:description [ fhir:text [ fhir:v "Negative" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "Negative" ] ] ] ) ] [ fhir:id [ fhir:v "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f" ] ; fhir:description [ fhir:text [ fhir:v "As Reported" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "As Reported" ] ] ] ) ] [ fhir:id [ fhir:v "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73" ] ; fhir:description [ fhir:text [ fhir:v "As Reported" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "As Reported" ] ] ] ) ] [ fhir:id [ fhir:v "464f3063-0a4b-4408-9f4a-d6c0b8170097" ] ; fhir:description [ fhir:text [ fhir:v "<= 3 ppm" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "3"^^xsd:decimal ] ; fhir:unit [ fhir:v "parts per million" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48523" ] ] ] ) ] [ fhir:id [ fhir:v "03fbc16c-d4d4-40ac-8689-448bda831dac" ] ; fhir:description [ fhir:text [ fhir:v "<= 10 ppm" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "10"^^xsd:decimal ] ; fhir:unit [ fhir:v "parts per million" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48523" ] ] ] ) ] [ fhir:id [ fhir:v "28aba010-126e-4c47-8611-367cdacdd87e" ] ; fhir:description [ fhir:text [ fhir:v "As Reported" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ; fhir:text [ fhir:v "As Reported" ] ] ] ) ] [ fhir:id [ fhir:v "4b3aa353-3bc7-463f-b4c2-defd041da2c7" ] ; fhir:description [ fhir:text [ fhir:v "<= 2.0%" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61586" ] ; fhir:display [ fhir:v "NMT (not more than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "2"^^xsd:decimal ] ; fhir:unit [ fhir:v "percent" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48570" ] ] ] ) ] [ fhir:id [ fhir:v "8125f603-96e7-4f3e-8b13-c15c5870e6e6" ] ; fhir:description [ fhir:text [ fhir:v "<30ml H2O @ 25C" ] ] ; ( fhir:addresses [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C61585" ] ; fhir:display [ fhir:v "LT (less than)" ] ] ) ] ] ) ; fhir:value [ fhir:v "30"^^xsd:decimal ] ; fhir:unit [ fhir:v "mL" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C28254" ] ] ] [ fhir:detail [ a fhir:Quantity ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-interpretation-code-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48793" ] ; fhir:display [ fhir:v "EQ" ] ] ) ] ] ) ; fhir:value [ fhir:v "25"^^xsd:decimal ] ; fhir:unit [ fhir:v "degree Celsius" ] ; fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C42559" ] ] ] ) ] ) ; # fhir:action ( [ fhir:id [ fhir:v "428fa917-a7d3-4515-9b48-c9366acd673a" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Identification" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC7" ] ; fhir:display [ fhir:v "Identification" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-001" ] ] ) ; ( fhir:action [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1.1"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Identification A" ] ; ( fhir:goalId [ fhir:v "e512320e-0ffb-47d9-922a-5415aaa4cb30" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1.2"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Identification B" ] ; ( fhir:goalId [ fhir:v "2c6e465b-4dec-4a09-9dc5-58c480009d27" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1.3"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Identification C" ] ; ( fhir:goalId [ fhir:v "c233a5f7-37e2-4b2b-9f04-cf1b25534865" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1.4"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Identification D" ] ; ( fhir:goalId [ fhir:v "c759888d-1eac-4a12-aa9b-403f395f2c18" ] ) ] ) ] [ fhir:id [ fhir:v "f7cbb73f-4220-4987-b498-c049230091ea" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Microbial Limits" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC13" ] ; fhir:display [ fhir:v "Microbial Limits" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-002" ] ] ) ; ( fhir:action [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2.1"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Total Bacterial Count" ] ; ( fhir:goalId [ fhir:v "66d4035c-633a-49b1-b974-e3171911f44a" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2.2"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Salmonella" ] ; ( fhir:goalId [ fhir:v "95bf9d43-f337-4905-9c50-788b69d00843" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2.3"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Escherichia Coli" ] ; ( fhir:goalId [ fhir:v "4e475e2c-c235-4433-b1e4-201a17e45796" ] ) ] ) ] [ fhir:id [ fhir:v "f5f8221c-f9ec-4b47-8ec7-90ff44f7388c" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Elemental Impurities" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "UV" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC98" ] ; fhir:display [ fhir:v "elemental impurity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-003" ] ] ) ; ( fhir:action [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3.1"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Cadmium (Cd)" ] ; ( fhir:goalId [ fhir:v "af4ec6c3-4590-43f7-92e0-c8dae0e76e1f" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3.2"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Mercury (Hg)" ] ; ( fhir:goalId [ fhir:v "b00cb099-5fd8-4ef4-b05b-c1c7c4cd4c73" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3.3"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Arsenic (As)" ] ; ( fhir:goalId [ fhir:v "464f3063-0a4b-4408-9f4a-d6c0b8170097" ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "3.4"^^xsd:decimal ] ] ) ; fhir:title [ fhir:v "Lead (Pb)" ] ; ( fhir:goalId [ fhir:v "03fbc16c-d4d4-40ac-8689-448bda831dac" ] ) ] ) ] [ fhir:id [ fhir:v "37b44e91-529a-4d87-843b-ec3dd172c09f" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "4"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Residual Solvents" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "2"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "SUBC101" ] ; fhir:display [ fhir:v "residual solvent" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-004" ] ] ) ; ( fhir:goalId [ fhir:v "28aba010-126e-4c47-8611-367cdacdd87e" ] ) ] [ fhir:id [ fhir:v "25a64081-a0c2-4d72-8a48-538f81fcc35f" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "5"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Impurity: Insoluble Matter" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC53" ] ; fhir:display [ fhir:v "Impurity" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-005" ] ] ) ; ( fhir:goalId [ fhir:v "4b3aa353-3bc7-463f-b4c2-defd041da2c7" ] ) ] [ fhir:id [ fhir:v "055a79d2-3f6b-49ec-a129-6feac5c33812" ] ; ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-order-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "6"^^xsd:decimal ] ] ) ; fhir:prefix [ fhir:v "Single Stage" ] ; fhir:title [ fhir:v "Solubility in H2O" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C96103" ] ; fhir:display [ fhir:v "Proprietary" ] ] ) ; fhir:text [ fhir:v "Visual" ] ] ; ( fhir:reason [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-test-category-codes"^^xsd:anyURI ] ; fhir:code [ fhir:v "TC24" ] ; fhir:display [ fhir:v "Solubility" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "EX-TEST-006" ] ] ) ; ( fhir:goalId [ fhir:v "8125f603-96e7-4f3e-8b13-c15c5870e6e6" ] ) ] ) . #
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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