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
@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:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "6004e36e-7df9-469d-9b29-8e9f9bd7e95f"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151> ] ) ] ; # fhir:identifier [ ( fhir:extension [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-ig-version"^^xsd:anyURI ] ; fhir:value [ fhir:v "0.1.17" ] ] ) ; fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:uuid:3e9cc7a1-e157-4b46-980a-33a8e50dcf65" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-12-15T22:36:51.299Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:5f66b17e-e3c0-4ee4-8106-59faa34d70f7"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:5f66b17e-e3c0-4ee4-8106-59faa34d70f7> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> ) ] [ fhir:fullUrl [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> ) ] ) . # <urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f> a fhir:Composition ; fhir:id [ fhir:v "55d92f43-e328-4011-bbcf-744e3afd954f"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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></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>: <a href=\"#Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\">See above (urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a)</a></p><p><b>title</b>: Quality Specification for an API</p></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "ExampleSpecification2" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ; fhir:code [ fhir:v "SP4151" ] ; fhir:display [ fhir:v "Quality Specification" ] ] ) ] ; # fhir:date [ fhir:v "2023-12-15T22:36:51.299Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a" ] ] ) ; # fhir:title [ fhir:v "Quality Specification for an API"] ; # fhir:section ( [ fhir:title [ fhir:v "32S41" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types"^^xsd:anyURI ] ; fhir:code [ fhir:v "32S41" ] ; fhir:display [ fhir:v "Substance Specification" ] ] ) ] ; ( fhir:entry [ fhir:reference [ fhir:v "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93" ] ] ) ] ) . # <urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93> a fhir:PlanDefinition ; fhir:id [ fhir:v "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"] ; # 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\"><a name=\"PlanDefinition_cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93\"> </a><p><b>Generated Narrative: PlanDefinition</b><a name=\"cc82a0ce-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\">Dummy NCIT Codesystem</a>#C134022)</span></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>status</b>: active</p><p><b>subject</b>: <a href=\"#SubstanceDefinition_5f66b17e-e3c0-4ee4-8106-59faa34d70f7\">See above (urn:uuid:5f66b17e-e3c0-4ee4-8106-59faa34d70f7)</a></p><p><b>date</b>: 2022-12-08</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>Tentatively Approved <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C134010)</span></td></tr></table><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\">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>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\">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>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\">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>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\">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 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\">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>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\">Dummy NCIT Codesystem</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>" ] ; # 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 "C134022" ] ; fhir:display [ fhir:v "Drug Substance" ] ] ) ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "ExampleSpecification2" ] ] ) ; # fhir:version [ fhir:v "1.0"] ; # fhir:title [ fhir:v "Quality Specification for an API"] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "urn:uuid:5f66b17e-e3c0-4ee4-8106-59faa34d70f7" ] ] ; # fhir:date [ fhir:v "2022-12-08"^^xsd:date] ; # 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 "C134010" ] ; fhir:display [ fhir:v "Tentatively Approved" ] ] ) ] ] ) ; # fhir:approvalDate [ fhir:v "2022-12-08"^^xsd:date] ; # fhir:goal ( [ fhir:id [ fhir:v "b304ed45-5295-4082-9827-f20e1ff0d1d3" ] ; 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 "d4e38c52-30f6-4bb7-ab84-99439a7266ce" ] ; 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 "2abf1f19-e1b1-42e4-b943-79f5fa1642fe" ] ; 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 "c0ed4a79-8f40-4d26-8845-4cea166fb627" ] ; fhir:description [ fhir:text [ fhir:v "NMT 10 colony-forming units" ] ] ; ( 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 "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 "442983b5-bbc3-4534-9f1b-5ae5e4c531c1" ] ; fhir:description [ fhir:text [ fhir:v "NMT 100 colony-forming units" ] ] ; ( 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 "100"^^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:action ( [ fhir:id [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ; ( 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:title [ fhir:v "Microbiological Examination of Nonsterile Products" ] ; 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 "C96102" ] ; fhir:display [ fhir:v "Compendial" ] ] ) ; 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 "USP <61>" ] ] ) ; ( 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"^^xsd:decimal ] ] ) ; fhir:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ; fhir:prefix [ fhir:v "Stage 1" ] ; fhir:title [ fhir:v "Staphylococcus aureus" ] ; ( fhir:goalId [ fhir:v "b304ed45-5295-4082-9827-f20e1ff0d1d3" ] ) ] [ ( 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:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ; fhir:prefix [ fhir:v "Stage 2" ] ; fhir:title [ fhir:v "Pseudomonas aeruginosa" ] ; ( fhir:goalId [ fhir:v "d4e38c52-30f6-4bb7-ab84-99439a7266ce" ] ) ] [ ( 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:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ; fhir:prefix [ fhir:v "Stage 3" ] ; fhir:title [ fhir:v "Bacillus subtilis" ] ; ( fhir:goalId [ fhir:v "2abf1f19-e1b1-42e4-b943-79f5fa1642fe" ] ) ] [ ( 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:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ; fhir:prefix [ fhir:v "Stage 4" ] ; fhir:title [ fhir:v "Total Aerobic Microbial Count (TAMC)" ] ; ( fhir:goalId [ fhir:v "c0ed4a79-8f40-4d26-8845-4cea166fb627" ] ) ] [ ( 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:linkId [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ; fhir:prefix [ fhir:v "Stage 5" ] ; fhir:title [ fhir:v "Total Yeasts and Molds Count (TYMC)" ] ; ( fhir:goalId [ fhir:v "442983b5-bbc3-4534-9f1b-5ae5e4c531c1" ] ) ] ) ] ) . # <urn:uuid:5f66b17e-e3c0-4ee4-8106-59faa34d70f7> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "5f66b17e-e3c0-4ee4-8106-59faa34d70f7"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_5f66b17e-e3c0-4ee4-8106-59faa34d70f7\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"5f66b17e-e3c0-4ee4-8106-59faa34d70f7\"> </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 "5f66b17e-e3c0-4ee4-8106-59faa34d70f7" </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>: aspirin</p><p><b>classification</b>: Chemical <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ema-dummy.html\">Dummy EMA Codesystem</a>#1)</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\">Dummy NCIT Codesystem</a>#C134006)</span></p><p><b>manufacturer</b>: <a href=\"#Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">See above (urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5)</a></p><p><b>supplier</b>: <a href=\"#Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">See above (urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049)</a></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>XF417D3PSL <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (gsrs.ncats.nih.gov#XF417D3PSL)</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>ASPIRIN</td><td>GSRS Preferred Term <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cmc-ncit-dummy.html\">Dummy NCIT Codesystem</a>#C203355)</span></td><td>true</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "aspirin" ] ] ) ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ema-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "1" ] ; fhir:display [ fhir:v "Chemical" ] ] ) ] ) ; # fhir:grade ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134006" ] ; fhir:display [ fhir:v "USP-NF" ] ] ) ] ) ; # fhir:manufacturer ( [ fhir:reference [ fhir:v "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5" ] ] ) ; # fhir:supplier ( [ fhir:reference [ fhir:v "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049" ] ] ) ; # fhir:code ( [ fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://gsrs.ncats.nih.gov"^^xsd:anyURI ] ; fhir:code [ fhir:v "XF417D3PSL" ] ] ) ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "ASPIRIN" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C203355" ] ; fhir:display [ fhir:v "GSRS Preferred Term" ] ] ) ] ; fhir:preferred [ fhir:v "true"^^xsd:boolean ] ] ) . # <urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a> a fhir:Organization ; fhir:id [ fhir:v "4f3e9af1-306b-4fad-bf04-7881400b266a"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-sponsor-organization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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></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>" ] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134003" ] ; fhir:display [ fhir:v "DUNS" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "143265222" ] ] ) ; # fhir:name [ fhir:v "Wunderwerke"] ; # fhir:contact ( [ fhir:address [ fhir:text [ fhir:v "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478" ] ; ( fhir:line [ fhir:v "123 Scenic Road" ] ) ; fhir:city [ fhir:v "Bridgeport" ] ; fhir:state [ fhir:v "CT" ] ; fhir:postalCode [ fhir:v "65478" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5> a fhir:Organization ; fhir:id [ fhir:v "e99bddfa-c1b5-435b-bbe8-24816b4e23e5"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/mfg-test-site-organization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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></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>" ] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134003" ] ; fhir:display [ fhir:v "DUNS" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "143265222" ] ] [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134004" ] ; fhir:display [ fhir:v "FEI" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:2.16.840.1.113883.4.82"^^xsd:anyURI ] ; fhir:value [ fhir:v "6981397" ] ] ) ; # fhir:name [ fhir:v "Vidinaid"] ; # fhir:contact ( [ fhir:address [ fhir:text [ fhir:v "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA" ] ; ( fhir:line [ fhir:v "100 Stillwater Avenue" ] [ fhir:v "Building #2" ] ) ; fhir:city [ fhir:v "Bangor" ] ; fhir:state [ fhir:v "ME" ] ; fhir:postalCode [ fhir:v "04401" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . # <urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049> a fhir:Organization ; fhir:id [ fhir:v "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/supplier-organization> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<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></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>" ] ; # fhir:identifier ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134003" ] ; fhir:display [ fhir:v "DUNS" ] ] ) ] ; fhir:system [ fhir:v "urn:oid:1.3.6.1.4.1.519.1"^^xsd:anyURI ] ; fhir:value [ fhir:v "173265332" ] ] ) ; # fhir:name [ fhir:v "Mega Chem Supply"] ; # fhir:contact ( [ fhir:address [ fhir:text [ fhir:v "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States" ] ; ( fhir:line [ fhir:v "350 W Main Street" ] ) ; fhir:city [ fhir:v "Rochester" ] ; fhir:state [ fhir:v "NY" ] ; fhir:postalCode [ fhir:v "14608" ] ; fhir:country [ fhir:v "USA" ] ] ] ) . #
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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