Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions
// Substance Batch Info
{
"resourceType" : "Bundle",
"id" : "bundle-drug-substance-batch-info-pq-ex1",
"meta" : // id value="substance-batch-analysis"/
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq"
]
},
"type" : "collection",
"entry" : [
{
"fullUrl" : "urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "8dae93e0-048d-35a4-71ea-7c603184a130",
"text" : // substance1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_8dae93e0-048d-35a4-71ea-7c603184a130\"> </a><p><b>Generated Narrative: SubstanceDefinition</b><a name=\"8dae93e0-048d-35a4-71ea-7c603184a130\"> </a><a name=\"hc8dae93e0-048d-35a4-71ea-7c603184a130\"> </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 "8dae93e0-048d-35a4-71ea-7c603184a130" </p></div><p><b>manufacturer</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</p><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Stelbatolol</td></tr></table></div>"
},
"manufacturer" : [
{
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
],
"name" : [
// Organization/substance-manufacturer
{
"name" : "Stelbatolol"
}
]
}
},
{
"fullUrl" : "urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330",
"resource" : {
"resourceType" : "Organization",
"id" : "3d399cbc-244e-9b5f-838b-b7daa0489330",
"text" : // substance-manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_3d399cbc-244e-9b5f-838b-b7daa0489330\"> </a><p><b>Generated Narrative: Organization</b><a name=\"3d399cbc-244e-9b5f-838b-b7daa0489330\"> </a><a name=\"hc3d399cbc-244e-9b5f-838b-b7daa0489330\"> </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 "3d399cbc-244e-9b5f-838b-b7daa0489330" </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3003040516</p><p><b>active</b>: true</p><p><b>type</b>: Drug Substance Manufacture <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#drug-substance-manufacture)</span></p><p><b>name</b>: AAA Molybdenum Products, Inc.</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>7233 W 116th Pl Ste C Broomfield Colorado 80020 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3003040516"
}
],
"active" : true,
"type" : [
// FDA establishment identifier
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
"code" : "drug-substance-manufacture",
"display" : "Drug Substance Manufacture"
}
]
}
],
"name" : "AAA Molybdenum Products, Inc.",
"contact" : [
{
"address" : {
"line" : [
"7233 W 116th Pl",
"Ste C"
],
"city" : "Broomfield",
"state" : "Colorado",
"postalCode" : "80020",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1",
"resource" : {
"resourceType" : "Substance",
"id" : "87ef899b-14dd-26b7-7416-7ec1d01b62a1",
"text" : // substance-dxpq-ex1
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Substance_87ef899b-14dd-26b7-7416-7ec1d01b62a1\"> </a><p><b>Generated Narrative: Substance</b><a name=\"87ef899b-14dd-26b7-7416-7ec1d01b62a1\"> </a><a name=\"hc87ef899b-14dd-26b7-7416-7ec1d01b62a1\"> </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 Substance "87ef899b-14dd-26b7-7416-7ec1d01b62a1" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-01</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Manufacturing Process PQ</b>: <span>: Process 1.1</span></p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: CAT1</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td>See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130</td></tr></table></div>"
},
"extension" : [
// was actual-batch-substance
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-01"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-manufacturing-process-pq",
"valueReference" : {
"display" : "Process 1.1"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT1"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4",
"resource" : {
"resourceType" : "Substance",
"id" : "6412c5d4-1b7d-8405-85dc-75dbaa300ea4",
"text" : // actual-batch-substance-2
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Substance_6412c5d4-1b7d-8405-85dc-75dbaa300ea4\"> </a><p><b>Generated Narrative: Substance</b><a name=\"6412c5d4-1b7d-8405-85dc-75dbaa300ea4\"> </a><a name=\"hc6412c5d4-1b7d-8405-85dc-75dbaa300ea4\"> </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 Substance "6412c5d4-1b7d-8405-85dc-75dbaa300ea4" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-02</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: CAT2</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td>See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130</td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-02"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT2"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
}
}
}
},
// SubstanceDefinition/substance1
{
"fullUrl" : "urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7",
"resource" : {
"resourceType" : "Substance",
"id" : "ef17cff1-6586-a4a4-9168-2602140548d7",
"text" : // actual-batch-substance-3
{
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Substance_ef17cff1-6586-a4a4-9168-2602140548d7\"> </a><p><b>Generated Narrative: Substance</b><a name=\"ef17cff1-6586-a4a4-9168-2602140548d7\"> </a><a name=\"hcef17cff1-6586-a4a4-9168-2602140548d7\"> </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 Substance "ef17cff1-6586-a4a4-9168-2602140548d7" </p></div><blockquote><p><b>Medication Manufacturing Batch</b></p><blockquote><p><b>url</b></p><code>manufacturingDate</code></blockquote><p><b>value</b>: 2020-03</p><blockquote><p><b>url</b></p><code>batchQuantity</code></blockquote><p><b>value</b>: 120 kg</p><blockquote><p><b>url</b></p><code>batchUtilization</code></blockquote><p><b>value</b>: Production <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C133990 "Commercial")</span></p><blockquote><p><b>url</b></p><code>assignedManufacturer</code></blockquote><p><b>value</b>: See on this page: Organization/3d399cbc-244e-9b5f-838b-b7daa0489330</p></blockquote><p><b>Extension - Batch Release Date PQ</b>: 2019-09-08</p><p><b>Extension - Batch Retest Date PQ</b>: 2022-09-08</p><p><b>Extension - Actual Yield PQ</b>: 4.8 kg</p><p><b>identifier</b>: CAT3</p><p><b>instance</b>: true</p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td>See on this page: SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130</td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-03"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 120,
"unit" : "kg"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/3d399cbc-244e-9b5f-838b-b7daa0489330"
}
}
]
},
// Organization/substance-manufacturer
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq",
"valueDateTime" : "2019-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-retest-date-pq",
"valueDateTime" : "2022-09-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"identifier" : [
// local extensions
{
"value" : "CAT3"
}
],
"instance" : true,
"code" : {
"reference" : {
"reference" : "SubstanceDefinition/8dae93e0-048d-35a4-71ea-7c603184a130"
}
}
}
}
]
}
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0. Generated 2024-05-08
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change