Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot 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-fda/ and changes regularly. See the Directory of published versions
{
"resourceType" : "Bundle",
"id" : "6004e36e-7df9-469d-9b29-8e9f9bd7e95f",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"
]
},
"identifier" : {
"system" : "urn:ietf:rfc:3986",
"value" : "urn:uuid:3e9cc7a1-e157-4b46-980a-33a8e50dcf65"
},
"type" : "document",
"timestamp" : "2023-12-15T22:36:51.299Z",
"entry" : [
{
"fullUrl" : "urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f",
"resource" : {
"resourceType" : "Composition",
"id" : "55d92f43-e328-4011-bbcf-744e3afd954f",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"
]
},
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"value" : "ExampleSpecification2"
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use",
"code" : "ich_3.2.s.4.1",
"display" : "Specification"
}
]
},
"date" : "2023-12-15T22:36:51.299Z",
"author" : [
{
"reference" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
}
],
"title" : "Quality Specification for an API",
"section" : [
{
"title" : "32S41",
"entry" : [
{
"reference" : "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93",
"resource" : {
"resourceType" : "PlanDefinition",
"id" : "cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"
]
},
"text" : {
"status" : "extensions",
"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=\"http://terminology.hl7.org/5.1.0/CodeSystem-v3-nciThesaurus.html\">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>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134010",
"display" : "Tentatively Approved"
}
]
}
},
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension",
"valueMarkdown" : "This API is is currently characterized through a standard battery of physicochemical characterzation tests."
}
],
"identifier" : [
{
"value" : "ExampleSpecification2"
}
],
"version" : "1.0",
"title" : "Quality Specification for an API",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/plan-definition-type",
"code" : "workflow-definition",
"display" : "Workflow Definition"
},
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134022",
"display" : "Drug Substance"
}
]
},
"status" : "active",
"subjectReference" : {
"reference" : "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"
},
"date" : "2022-12-08",
"approvalDate" : "2022-12-08",
"goal" : [
{
"id" : "b304ed45-5295-4082-9827-f20e1ff0d1d3",
"description" : {
"text" : "Negative"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailString" : "Negative"
}
]
},
{
"id" : "d4e38c52-30f6-4bb7-ab84-99439a7266ce",
"description" : {
"text" : "Negative"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailString" : "Negative"
}
]
},
{
"id" : "2abf1f19-e1b1-42e4-b943-79f5fa1642fe",
"description" : {
"text" : "Negative"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailString" : "Negative"
}
]
},
{
"id" : "c0ed4a79-8f40-4d26-8845-4cea166fb627",
"description" : {
"text" : "NMT 10 colony-forming units"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailQuantity" : {
"value" : 10,
"comparator" : "<=",
"unit" : "colony forming unit",
"system" : "http://unitsofmeasure.org",
"code" : "[CFU]"
}
}
]
},
{
"id" : "442983b5-bbc3-4534-9f1b-5ae5e4c531c1",
"description" : {
"text" : "NMT 100 colony-forming units"
},
"addresses" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134029",
"display" : "Release"
}
]
},
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134030",
"display" : "Stability"
}
]
}
],
"target" : [
{
"detailQuantity" : {
"value" : 100,
"comparator" : "<=",
"unit" : "colony forming unit",
"system" : "http://unitsofmeasure.org",
"code" : "[CFU]"
}
}
]
}
],
"action" : [
{
"id" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"title" : "Microbiological Examination of Nonsterile Products",
"code" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C96102",
"display" : "Compendial"
}
],
"text" : "Visual"
},
"reason" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
"valuePositiveInt" : 1
}
],
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134256",
"display" : "Microbial Limits"
}
]
}
],
"documentation" : [
{
"type" : "documentation",
"label" : "USP <61>"
}
],
"action" : [
{
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 1",
"title" : "Staphylococcus aureus",
"goalId" : [
"b304ed45-5295-4082-9827-f20e1ff0d1d3"
]
},
{
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 2",
"title" : "Pseudomonas aeruginosa",
"goalId" : [
"d4e38c52-30f6-4bb7-ab84-99439a7266ce"
]
},
{
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 3",
"title" : "Bacillus subtilis",
"goalId" : [
"2abf1f19-e1b1-42e4-b943-79f5fa1642fe"
]
},
{
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 4",
"title" : "Total Aerobic Microbial Count (TAMC)",
"goalId" : [
"c0ed4a79-8f40-4d26-8845-4cea166fb627"
]
},
{
"linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
"prefix" : "Stage 5",
"title" : "Total Yeasts and Molds Count (TYMC)",
"goalId" : [
"442983b5-bbc3-4534-9f1b-5ae5e4c531c1"
]
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "580c28ac-1a2c-49fa-9be3-de997da5edcf",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"value" : "P-Isobutylhydratropic Acid"
}
],
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"manufacturer" : [
{
"reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
}
],
"supplier" : [
{
"reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "WK2XYI10QM"
}
]
}
}
],
"name" : [
{
"name" : "IBUPROFENPIRIN",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
]
}
},
{
"fullUrl" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a",
"resource" : {
"resourceType" : "Organization",
"id" : "4f3e9af1-306b-4fad-bf04-7881400b266a",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
}
],
"name" : "Wunderwerke",
"contact" : [
{
"address" : {
"type" : "postal",
"text" : "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478",
"line" : [
"123 Scenic Road"
],
"city" : "Bridgeport",
"state" : "CT",
"postalCode" : "65478",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
"resource" : {
"resourceType" : "Organization",
"id" : "e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "143265222"
},
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134004",
"display" : "FEI"
}
]
},
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "6981397"
}
],
"name" : "Vidinaid",
"contact" : [
{
"address" : {
"type" : "postal",
"text" : "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA",
"line" : [
"100 Stillwater Avenue",
"Building #2"
],
"city" : "Bangor",
"state" : "ME",
"postalCode" : "04401",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
"resource" : {
"resourceType" : "Organization",
"id" : "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text" : {
"status" : "generated",
"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>"
},
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134003",
"display" : "DUNS"
}
]
},
"system" : "urn:oid:1.3.6.1.4.1.519.1",
"value" : "173265332"
}
],
"name" : "Mega Chem Supply",
"contact" : [
{
"address" : {
"type" : "postal",
"text" : "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States",
"line" : [
"350 W Main Street"
],
"city" : "Rochester",
"state" : "NY",
"postalCode" : "14608",
"country" : "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 2024-12-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change