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
{
"resourceType" : "Medication",
"id" : "medication-batch-information-drug-pq-ex1",
"meta" : // Contained in Accumulus FHIR Product Example - Stability (2-24-2023) and updated based on Accumulus FHIR Product Example - Process Validation.xml (07-11-2023)
// Section 8 - Batch or Lot Information (batch 1 of 3)
// <id value="medication-actual-batch"/>
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Medication-batch-information-drug-pq"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: Medication</b><a name=\"medication-batch-information-drug-pq-ex1\"> </a><a name=\"hcmedication-batch-information-drug-pq-ex1\"> </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 Medication "medication-batch-information-drug-pq-ex1" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-Medication-batch-information-drug-pq.html\">Medication - Batch Information Drug PQ</a></p></div><p><b>code</b>: <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><h3>Batches</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Extension</b></td><td><b>LotNumber</b></td></tr><tr><td style=\"display: none\">*</td><td>, , , , , , , , , </td><td>33445</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
🔗 "reference" : "MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1"
}
}
]
},
"batch" : // New order, with all Extensions custom to this IG at the top
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
// Base FHIR Extensions
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
// #157
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100100,
"unit" : "tablets"
}
},
// #26
// #155
// need to see if one of these needs changing
{
"url" : "batchUtilization",
"valueCodeableConcept" : // #159
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C133990",
"display" : "Commercial"
}
],
"text" : "Production"
}
},
// <!-\- Extension custom for this IG -\->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-instance-comment-pq">
<!-\- <extension url="http://nprogram.co.uk/fhir/extension/instanceComment">-\->
<valueCodeableConcept value="Comment: This has a value set defined in PQ/CMC but no code system"
/>
<!-\- <valueString value="Comment: This has a value set defined in PQ/CMC but no code system"/>-\->
</extension>
{
"url" : "assignedManufacturer",
"valueReference" : {
🔗 "reference" : "Organization/organization-drug-pq-ex1"
}
},
// #158
{
"url" : "container",
"extension" : [
{
"url" : "closureSystemDescription",
"valueString" : "100 cc HDPE Bottle 2 g desiccant"
}
]
}
]
},
{
"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-designation-pq",
"valueCodeableConcept" : // <extension url="http://accumulus.org/fhir/extension/batchDesignation">
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/batch-designation",
"code" : "maximum",
"display" : "Maximum"
}
],
"text" : "Maximum"
}
},
// <system value="http://temp.hl7.org/fhir/us/pq-cmc/CodeSystem/pqcmc-batch-designation"/>
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-number-of-vials-pq",
"valuePositiveInt" : 3
},
// <extension url="http://accumulus.org/fhir/extension/batchNumberOfVials">
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-substance-batch-pq",
"valueReference" : // <extension url="http://accumulus.org/fhir/extension/batchSubstanceBatch">
// <reference value="Substance/actual-batch-substance"/>
{
🔗 "reference" : "Substance/substance-drug-pq-ex1"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : // <extension url="http://accumulus.org/fhir/extension/packagingSite">
{
🔗 "reference" : "Organization/organization-drug-pq-ex1"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.81,
"unit" : "kg"
}
},
// #160
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-unfiltered-pq",
"valueQuantity" : {
"value" : 4.91,
"unit" : "kg"
}
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-target-fill-weight-pq",
"valueQuantity" : {
"value" : 30,
"unit" : "g"
}
}
],
"lotNumber" : "33445"
}
}
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
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