Publication Build: This will be filled in by the publication tooling
@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: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:580c28ac-1a2c-49fa-9be3-de997da5edcf"^^xsd:anyURI ] ; ( fhir:resource <urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf> ) ] [ 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 class=\"res-header-id\"><b>Generated Narrative: Composition 55d92f43-e328-4011-bbcf-744e3afd954f</b></p><a name=\"55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><a name=\"hc55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><a name=\"55d92f43-e328-4011-bbcf-744e3afd954f-en-US\"> </a><p><b>identifier</b>: ExampleSpecification2</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use ich_3.2.s.4.1}\">Specification</span></p><p><b>date</b>: 2023-12-15 22:36:51+0000</p><p><b>author</b>: <a href=\"Bundle-49d3b79e-b436-a242-93ba-b706b4364ab2.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000</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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use"^^xsd:anyURI ] ; fhir:code [ fhir:v "ich_3.2.s.4.1" ] ; fhir:display [ fhir:v "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: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>\n<div>\n <table class=\"grid dict\">\n \n <tr>\n <th scope=\"row\"><b>Id: </b></th>\n <td style=\"padding-left: 4px;\">cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93</td>\n </tr>\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Version: </b></th>\n <td style=\"padding-left: 4px;\">1.0</td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\">\n <b>\n \n \n \n </b>\n </th>\n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <span>ExampleSpecification2</span>\n </p>\n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Title: </b></th>\n <td style=\"padding-left: 4px;\">Quality Specification for an API</td>\n </tr>\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Type: </b></th>\n <td style=\"padding-left: 4px;\">\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>workflow-definition</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Workflow Definition</span>\n </p>\n \n \n \n <p style=\"margin-bottom: 5px;\">\n <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>code: </b> <span>C134022</span>\n </p>\n \n \n <p style=\"margin-bottom: 5px;\">\n <b>display: </b> <span>Drug Substance</span>\n </p>\n \n \n \n \n </td>\n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Subject: </b></th>\n \n \n <td style=\"padding-left: 4px;\">\n \n <p style=\"margin-bottom: 5px;\">\n <b>reference: </b> <span>urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf</span>\n </p>\n \n \n \n </td>\n \n </tr>\n \n\n \n <tr>\n <th scope=\"row\"><b>Date: </b></th>\n <td style=\"padding-left: 4px;\">2022-12-08</td>\n </tr>\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Approval Date: </b></th>\n <td style=\"padding-left: 4px;\">2022-12-08</td>\n </tr>\n \n\n \n\n \n\n \n\n \n <tr>\n <th scope=\"row\"><b>Actions: </b></th>\n <td style=\"padding-left: 4px;\">\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b> Microbiological Examination of Nonsterile Products:</b> \n \n <br/>\n \n \n \n <b>Then:</b>\n <table class=\"grid-dict\">\n \n <tr>\n <td>\n \n <b>Stage 1 Staphylococcus aureus:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Stage 2 Pseudomonas aeruginosa:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Stage 3 Bacillus subtilis:</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Stage 4 Total Aerobic Microbial Count (TAMC):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n <tr>\n <td>\n \n <b>Stage 5 Total Yeasts and Molds Count (TYMC):</b>\n \n \n <br/>\n \n \n \n \n \n </td>\n </tr>\n \n </table>\n \n </td>\n </tr>\n \n </table>\n </td>\n </tr>\n \n </table>\n</div>\n</div>" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134010" ] ; fhir:display [ fhir:v "Tentatively Approved" ] ] ) ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension"^^xsd:anyURI ] ; fhir:value [ fhir:v "This API is is currently characterized through a standard battery of physicochemical characterzation tests." ] ] ) ; # fhir:identifier ( [ fhir:value [ fhir:v "ExampleSpecification2" ] ] ) ; # fhir:version [ fhir:v "1.0"] ; # fhir:title [ fhir:v "Quality Specification for an API"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/plan-definition-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "workflow-definition" ] ; fhir:display [ fhir:v "Workflow Definition" ] ] [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134022" ] ; fhir:display [ fhir:v "Drug Substance" ] ] ) ] ; # fhir:status [ fhir:v "active"] ; # fhir:subject [ a fhir:Reference ; fhir:reference [ fhir:v "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf" ] ] ; # fhir:date [ fhir:v "2022-12-08"^^xsd:date] ; # 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "10"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "colony forming unit" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "[CFU]" ] ] ] ) ] [ 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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134029" ] ; fhir:display [ fhir:v "Release" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134030" ] ; fhir:display [ fhir:v "Stability" ] ] ) ] ) ; ( fhir:target [ fhir:detail [ a fhir:Quantity ; fhir:value [ fhir:v "100"^^xsd:decimal ] ; fhir:comparator [ fhir:v "<=" ] ; fhir:unit [ fhir:v "colony forming unit" ] ; fhir:system [ fhir:v "http://unitsofmeasure.org"^^xsd:anyURI ] ; fhir:code [ fhir:v "[CFU]" ] ] ] ) ] ) ; # fhir:action ( [ fhir:id [ fhir:v "997a8ec6-eabf-41a3-b166-ddc3dfb35c27" ] ; fhir:title [ fhir:v "Microbiological Examination of Nonsterile Products" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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:positiveInteger ] ] ) ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C134256" ] ; fhir:display [ fhir:v "Microbial Limits" ] ] ) ] ) ; ( fhir:documentation [ fhir:type [ fhir:v "documentation" ] ; fhir:label [ fhir:v "USP <61>" ] ] ) ; ( fhir:action [ 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: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: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: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: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:580c28ac-1a2c-49fa-9be3-de997da5edcf> a fhir:SubstanceDefinition ; fhir:id [ fhir:v "580c28ac-1a2c-49fa-9be3-de997da5edcf"] ; # 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_580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 580c28ac-1a2c-49fa-9be3-de997da5edcf</b></p><a name=\"580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><a name=\"hc580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><a name=\"580c28ac-1a2c-49fa-9be3-de997da5edcf-en-US\"> </a><p><b>identifier</b>: P-Isobutylhydratropic Acid</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-6004e36e-7df9-469d-9b29-8e9f9bd7e95f.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000</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><span title=\"Codes:{http://fdasis.nlm.nih.gov WK2XYI10QM}\">WK2XYI10QM</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>IBUPROFENPIRIN</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:value [ fhir:v "P-Isobutylhydratropic Acid" ] ] ) ; # fhir:classification ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C48807" ] ; fhir:display [ fhir:v "Chemical" ] ] ) ] ) ; # fhir:grade ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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 "http://fdasis.nlm.nih.gov"^^xsd:anyURI ] ; fhir:code [ fhir:v "WK2XYI10QM" ] ] ) ] ] ) ; # fhir:name ( [ fhir:name [ fhir:v "IBUPROFENPIRIN" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-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 class=\"res-header-id\"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a-en-US\"> </a><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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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:type [ fhir:v "postal" ] ; 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/cmc-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-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 class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5-en-US\"> </a><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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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:type [ fhir:v "postal" ] ; 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/cmc-organization"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-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 class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049-en-US\"> </a><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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^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:type [ fhir:v "postal" ] ; 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#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-12
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