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
<Bundle xmlns="http://hl7.org/fhir">
<!-- Product Batch Info -->
<id value="bundle-drug-product-batch-info-pq-ex1"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq"/>
</meta>
<type value="collection"/>
<!-- Section 8 - Batch or Lot Information (batch 1 of 3) -->
<entry>
<fullUrl value="urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
<resource>
<Medication>
<!-- medication-actual-batch -->
<id value="339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51"/>
<text>
<status value="generated"/>
<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>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>
<!-- todo consider change this be the MID? -->
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</valueReference>
</extension>
</code>
<batch>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2020-06"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="100100"/>
<unit value="tablets"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C185328"/>
<display value="Stability Study"/>
</coding>
<text value="PPQ / Stability"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/manufacturer -->
<reference
value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
</valueReference>
</extension>
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</extension>
</extension>
</extension>
<!-- local extensions -->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.8"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq">
<valueDateTime value="2020-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq">
<valueReference>
<!-- Organization/packaging -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
</valueReference>
</extension>
<lotNumber value="33445"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (another batch 2 of 3) -->
<entry>
<fullUrl value="urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
<resource>
<Medication>
<!-- medication-actual-batch-2 -->
<id value="a9dfda53-734b-045f-7ae4-94a6281d53bc"/>
<text>
<status value="generated"/>
<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>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</valueReference>
</extension>
</code>
<batch>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2020-06"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="100050"/>
<unit value="tablets"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C185328"/>
<display value="Stability Study"/>
</coding>
<text value="PPQ / Stability"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/manufacturer -->
<reference
value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
</valueReference>
</extension>
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</extension>
</extension>
</extension>
<!-- local extensions -->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.8"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq">
<valueDateTime value="2020-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq">
<valueReference>
<!-- Organization/packaging -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
</valueReference>
</extension>
<lotNumber value="33446"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 8 - Batch or Lot Information (another batch 3 of 3) -->
<entry>
<fullUrl value="urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
<resource>
<Medication>
<!-- medication-actual-batch-3 -->
<id value="c6f5fadd-62e6-3a01-93d9-b3b182f67d06"/>
<text>
<status value="generated"/>
<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>
</text>
<code>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq">
<valueReference>
<!-- MedicinalProductDefinition/medicinalproductdefinition-drug-product-dxpq-ex1 -->
<reference
value="MedicinalProductDefinition/a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
</valueReference>
</extension>
</code>
<batch>
<extension
url="http://hl7.org/fhir/StructureDefinition/medication-manufacturingBatch">
<extension url="manufacturingDate">
<valueDateTime value="2020-06"/>
</extension>
<extension url="batchQuantity">
<valueQuantity>
<value value="100125"/>
<unit value="tablets"/>
</valueQuantity>
</extension>
<extension url="batchUtilization">
<valueCodeableConcept>
<coding>
<system
value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C185328"/>
<display value="Stability Study"/>
</coding>
<text value="PPQ / Stability"/>
</valueCodeableConcept>
</extension>
<extension url="assignedManufacturer">
<valueReference>
<!-- Organization/manufacturer -->
<reference
value="Organization/0102bca4-46c1-a6bf-1025-cd403fee710a"/>
</valueReference>
</extension>
<extension url="container">
<extension url="closureSystemDescription">
<valueString value="100 cc HDPE Bottle 2 g desiccant"/>
</extension>
</extension>
</extension>
<!-- local extensions -->
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-batch-release-date-pq">
<valueDateTime value="2019-09-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-date-pq">
<valueDateTime value="2020-08"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-packaging-site-pq">
<valueReference>
<!-- Organization/packaging -->
<reference
value="Organization/378fbe5f-5926-3a5c-4c64-5428df877b07"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-actual-yield-pq">
<valueQuantity>
<value value="4.8"/>
<unit value="kg"/>
</valueQuantity>
</extension>
<lotNumber value="33447"/>
</batch>
</Medication>
</resource>
</entry>
<!-- Section 4.1 - Manufacturer -->
<entry>
<fullUrl value="urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a"/>
<resource>
<Organization>
<!-- manufacturer -->
<id value="0102bca4-46c1-a6bf-1025-cd403fee710a"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<!-- FDA establishment identifier -->
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3010027650"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
<code value="drug-product-manufacture"/>
<display value="Drug Product Manufacture"/>
</coding>
</type>
<name value="AAA Pharmaceutical, Inc."/>
<contact>
<address>
<line value="681 Main Street"/>
<city value="Lumberton"/>
<state value="New Jersey"/>
<postalCode value="08048"/>
<country value="USA"/>
</address>
</contact>
</Organization>
</resource>
</entry>
<entry>
<fullUrl value="urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07"/>
<resource>
<Organization>
<!-- packaging -->
<id value="378fbe5f-5926-3a5c-4c64-5428df877b07"/>
<text>
<status value="generated"/>
<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>
</text>
<identifier>
<system value="urn:oid:2.16.840.1.113883.4.82"/>
<value value="3008816891"/>
</identifier>
<active value="true"/>
<type>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type"/>
<code value="packaging"/>
<display value="Packaging"/>
</coding>
</type>
<name value="MySite"/>
</Organization>
</resource>
</entry>
<!-- MedicinalProductDefinition - the main resource in any product scenario -->
<entry>
<fullUrl value="urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<!-- Section 1.1 - DP Identification -->
<resource>
<MedicinalProductDefinition>
<!-- medicinalproductdefinition-drug-product-dxpq-ex1 -->
<id value="a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"/>
<text>
<status value="generated"/>
<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>
</text>
<description value="Textual description of the product"/>
<combinedPharmaceuticalDoseForm>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="10225000"/>
<display value="Gastro-resistant tablet"/>
</coding>
</combinedPharmaceuticalDoseForm>
<route>
<coding>
<system value="http://standardterms.edqm.eu"/>
<code value="20053000"/>
<display value="Oral use"/>
</coding>
</route>
<name>
<productName value="Stelbat Tablets, 20mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example"/>
<code value="Proprietary"/>
<display value="Proprietary"/>
</coding>
</type>
<part>
<part value="20mg"/>
<type>
<coding>
<system
value="http://hl7.org/fhir/medicinal-product-name-part-type"/>
<code value="StrengthPart"/>
<display value="Strength part"/>
</coding>
</type>
</part>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>
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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