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
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],
"text" : "FTIR"
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"action" : [
{
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"action" : [
{
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},
{
"fullUrl" : "urn:uuid:278736ef-2ddf-49e4-895c-3a9f34db36cf",
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"id" : "278736ef-2ddf-49e4-895c-3a9f34db36cf",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 278736ef-2ddf-49e4-895c-3a9f34db36cf</b></p><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"hc278736ef-2ddf-49e4-895c-3a9f34db36cf\"> </a><a name=\"278736ef-2ddf-49e4-895c-3a9f34db36cf-en-US\"> </a><p><b>identifier</b>: Cochineal</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 C134009}\">Company Standard</span></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 TZ8Z31B35M}\">TZ8Z31B35M</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>Cochineal</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><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Genus</b></td><td><b>Species</b></td><td><b>CountryOfOrigin</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td><td><span title=\"Codes:\">Dactylopius</span></td><td><span title=\"Codes:\">cochineal</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 TUR}\">Turkey</span></td></tr></table></div>"
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],
"grade" : [
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]
}
],
"code" : [
{
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],
"name" : [
{
"name" : "Cochineal",
"type" : {
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{
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},
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}
],
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{
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"code" : "C48807",
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}
]
},
"genus" : {
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},
"species" : {
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},
"countryOfOrigin" : [
{
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{
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"code" : "TUR",
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}
}
},
{
"fullUrl" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a",
"resource" : {
"resourceType" : "Organization",
"id" : "4f3e9af1-306b-4fad-bf04-7881400b266a",
"meta" : {
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🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"
]
},
"text" : {
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"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" : [
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}
]
},
"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"
}
}
]
}
}
]
}
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
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