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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"linkId" : "6d1ba5a8-6590-496a-ad6b-ca68cfda2878",
"prefix" : "Stage 2",
"goalId" : [
"47c0d685-0b23-4637-9af8-a554e4fad7ec",
"14d3dee8-e024-4367-b0a2-a2a809303ee0"
]
},
{
"linkId" : "6d1ba5a8-6590-496a-ad6b-ca68cfda2878",
"prefix" : "Stage 3",
"goalId" : [
"15309a78-92a9-4cf9-aee1-452d6d2f7a91",
"666ace1e-bd29-4263-9ae2-2391106326bb"
]
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9",
"resource" : {
"resourceType" : "MedicinalProductDefinition",
"id" : "89676a69-1fe7-422c-ab00-92abe4ef6ea9",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9</b></p><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><a name=\"hc89676a69-1fe7-422c-ab00-92abe4ef6ea9\"> </a><a name=\"89676a69-1fe7-422c-ab00-92abe4ef6ea9-en-US\"> </a><p><b>identifier</b>: Example2BeadDrug</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25158}\">CAPSULE</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Non-Proprietary</span></p><blockquote><p><b>part</b></p><p><b>part</b>: OXAZEPAM</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 30mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">OXAZEPAM</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: PROPRANOLOL HYDROCHLORIDE</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 60mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">PROPRANOLOL HYDROCHLORIDE</span></p></blockquote></blockquote></div>"
},
"identifier" : [
{
"value" : "Example2BeadDrug"
}
],
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C25158",
"display" : "CAPSULE"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C38288",
"display" : "ORAL"
}
]
}
],
"name" : [
{
"productName" : "OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C96971",
"display" : "Nonproprietary Name"
}
],
"text" : "Non-Proprietary"
},
"part" : [
{
"part" : "OXAZEPAM",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "SCI"
}
]
}
},
{
"part" : "30mg",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "STR"
}
],
"text" : "OXAZEPAM"
}
},
{
"part" : "PROPRANOLOL HYDROCHLORIDE",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "SCI"
}
]
}
},
{
"part" : "60mg",
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2",
"code" : "STR"
}
],
"text" : "PROPRANOLOL HYDROCHLORIDE"
}
}
]
}
]
}
},
{
"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"
}
}
]
}
}
]
}
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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