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" : "Bundle",
"id" : "bundle-drug-product-batch-info-pq-ex1",
"meta" : // Product Batch Info
{
"profile" : [
🔗 "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq"
]
},
"type" : "collection",
"entry" : [
// Section 8 - Batch or Lot Information (batch 1 of 3)
{
"fullUrl" : "urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
"resource" : {
"resourceType" : "Medication",
"id" : "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51",
"text" : // medication-actual-batch
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a><p><b>Generated Narrative: Medication</b><a name=\"339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </a><a name=\"hc339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51\"> </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 "339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51" </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/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // todo consider change this be the MID?
// MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100100,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C185328",
"display" : "Stability Study"
}
],
"text" : "PPQ / Stability"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
}
},
// Organization/manufacturer
{
"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-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
},
{
"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" : {
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
}
}
],
"lotNumber" : "33445"
}
}
},
// Organization/packaging
// local extensions
{
"fullUrl" : "urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc",
"resource" : {
"resourceType" : "Medication",
"id" : "a9dfda53-734b-045f-7ae4-94a6281d53bc",
"text" : // medication-actual-batch-2
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_a9dfda53-734b-045f-7ae4-94a6281d53bc\"> </a><p><b>Generated Narrative: Medication</b><a name=\"a9dfda53-734b-045f-7ae4-94a6281d53bc\"> </a><a name=\"hca9dfda53-734b-045f-7ae4-94a6281d53bc\"> </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 "a9dfda53-734b-045f-7ae4-94a6281d53bc" </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>33446</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100050,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C185328",
"display" : "Stability Study"
}
],
"text" : "PPQ / Stability"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
}
},
// Organization/manufacturer
{
"url" : "container",
"extension" : [
{
"url" : "closureSystemDescription",
"valueString" : "100 cc HDPE Bottle 2 g desiccant"
}
]
}
]
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
},
{
"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-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
}
}
],
"lotNumber" : "33446"
}
}
},
// Organization/packaging
// local extensions
{
"fullUrl" : "urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06",
"resource" : {
"resourceType" : "Medication",
"id" : "c6f5fadd-62e6-3a01-93d9-b3b182f67d06",
"text" : // medication-actual-batch-3
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Medication_c6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </a><p><b>Generated Narrative: Medication</b><a name=\"c6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </a><a name=\"hcc6f5fadd-62e6-3a01-93d9-b3b182f67d06\"> </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 "c6f5fadd-62e6-3a01-93d9-b3b182f67d06" </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>33447</td></tr></table></div>"
},
"code" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq",
"valueReference" : {
"reference" : "MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
}
}
]
},
"batch" : // MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch",
"extension" : [
{
"url" : "manufacturingDate",
"valueDateTime" : "2020-06"
},
{
"url" : "batchQuantity",
"valueQuantity" : {
"value" : 100125,
"unit" : "tablets"
}
},
{
"url" : "batchUtilization",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C185328",
"display" : "Stability Study"
}
],
"text" : "PPQ / Stability"
}
},
{
"url" : "assignedManufacturer",
"valueReference" : {
"reference" : "Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"
}
},
// Organization/manufacturer
{
"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-packaging-date-pq",
"valueDateTime" : "2020-08"
},
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq",
"valueReference" : {
"reference" : "Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"
}
},
// Organization/packaging
{
"url" : "http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq",
"valueQuantity" : {
"value" : 4.8,
"unit" : "kg"
}
}
],
"lotNumber" : "33447"
}
}
},
// local extensions
{
"fullUrl" : "urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a",
"resource" : {
"resourceType" : "Organization",
"id" : "0102bca4-46c1-a6bf-1025-cd403fee710a",
"text" : // manufacturer
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_0102bca4-46c1-a6bf-1025-cd403fee710a\"> </a><p><b>Generated Narrative: Organization</b><a name=\"0102bca4-46c1-a6bf-1025-cd403fee710a\"> </a><a name=\"hc0102bca4-46c1-a6bf-1025-cd403fee710a\"> </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 "0102bca4-46c1-a6bf-1025-cd403fee710a" </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3010027650</p><p><b>active</b>: true</p><p><b>type</b>: Drug Product Manufacture <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#drug-product-manufacture)</span></p><p><b>name</b>: AAA Pharmaceutical, 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>681 Main Street Lumberton New Jersey 08048 USA </td></tr></table></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3010027650"
}
],
"active" : true,
"type" : [
// FDA establishment identifier
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
"code" : "drug-product-manufacture",
"display" : "Drug Product Manufacture"
}
]
}
],
"name" : "AAA Pharmaceutical, Inc.",
"contact" : [
{
"address" : {
"line" : [
"681 Main Street"
],
"city" : "Lumberton",
"state" : "New Jersey",
"postalCode" : "08048",
"country" : "USA"
}
}
]
}
},
{
"fullUrl" : "urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07",
"resource" : {
"resourceType" : "Organization",
"id" : "378fbe5f-5926-3a5c-4c64-5428df877b07",
"text" : // packaging
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_378fbe5f-5926-3a5c-4c64-5428df877b07\"> </a><p><b>Generated Narrative: Organization</b><a name=\"378fbe5f-5926-3a5c-4c64-5428df877b07\"> </a><a name=\"hc378fbe5f-5926-3a5c-4c64-5428df877b07\"> </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 "378fbe5f-5926-3a5c-4c64-5428df877b07" </p></div><p><b>identifier</b>: <code>urn:oid:2.16.840.1.113883.4.82</code>/3008816891</p><p><b>active</b>: true</p><p><b>type</b>: Packaging <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-pharmaceutical-organization-type.html\">Pharmaceutical Organization Type Codes</a>#packaging)</span></p><p><b>name</b>: MySite</p></div>"
},
"identifier" : [
{
"system" : "urn:oid:2.16.840.1.113883.4.82",
"value" : "3008816891"
}
],
"active" : true,
"type" : [
{
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type",
"code" : "packaging",
"display" : "Packaging"
}
]
}
],
"name" : "MySite"
}
},
{
"fullUrl" : "urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"resource" : // Section 1.1 - DP Identification
{
"resourceType" : "MedicinalProductDefinition",
"id" : "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5",
"text" : // medicinalproductdefinition-drug-product-dxpq-ex1
{
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><p><b>Generated Narrative: MedicinalProductDefinition</b><a name=\"a0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </a><a name=\"hca0694a7a-aafa-4cbe-8135-c788a9a4d3d5\"> </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 MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5" </p></div><p><b>description</b>: Textual description of the product</p><p><b>combinedPharmaceuticalDoseForm</b>: Gastro-resistant tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#10225000)</span></p><p><b>route</b>: Oral use <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (standardterms.edqm.eu#20053000)</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Stelbat Tablets, 20mg</p><p><b>type</b>: Proprietary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-cs-productNameType-pq-example.html\">Product Name Type - example</a>#Proprietary)</span></p><h3>Parts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Part</b></td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td>20mg</td><td>Strength part <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R5/codesystem-medicinal-product-name-part-type.html\">Product Name Part Type</a>#StrengthPart)</span></td></tr></table></blockquote></div>"
},
"description" : "Textual description of the product",
"combinedPharmaceuticalDoseForm" : {
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "10225000",
"display" : "Gastro-resistant tablet"
}
]
},
"route" : [
{
"coding" : [
{
"system" : "http://standardterms.edqm.eu",
"code" : "20053000",
"display" : "Oral use"
}
]
}
],
"name" : [
{
"productName" : "Stelbat Tablets, 20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example",
"code" : "Proprietary",
"display" : "Proprietary"
}
]
},
"part" : [
{
"part" : "20mg",
"type" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/medicinal-product-name-part-type",
"code" : "StrengthPart",
"display" : "Strength part"
}
]
}
}
]
}
]
}
}
]
}
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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