Pharmaceutical Quality (Industry)
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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

Batch/Lot Information: synthetic data rendering - drug product

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.P.5 Control of Drug Product, subsection 3.2.P.5.4 Batch Analyses.

This is the same data as in the example files here in xml and in json, presented for easier viewing. Hovering on words below will show the corresponding sections of the underlying data.

Bundle [documentation R4 R5 R6]
id: bundle-drug-product-batch-info-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-product-batch-info-pq
Type: collection
Batch Information - Product, on Stelbat Tablets, 20mg

Details of Batches
Batches Table
Drug Product Batch Number 33445 33446 33447
Batch Size (Tablets) 100100 100050 100125
Scale PPQ / Stability PPQ / Stability PPQ / Stability
Site of Manufacture AAA Pharmaceutical, Inc., Lumberton AAA Pharmaceutical, Inc., Lumberton AAA Pharmaceutical, Inc., Lumberton
Date of Manufacture 2020-06 2020-06 2020-06

Subjects of Batch Information

Product [documentation R4 R5 R6]
id: medicinalproductdefinition-drug-product-dxpq-ex1
fullUrl: urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
- Name: Stelbat Tablets, 20mg
Name type: Proprietary [Proprietary] (http://hl7.org/fhir/uv/pharm-quality/CodeSystem/cs-productNameType-pq-example)
Strength name part: 20mg
Description: Textual description of the product
Route of Administration: Oral use [20053000] (http://standardterms.edqm.eu)
Dose Form (combination of all parts): Gastro-resistant tablet [10225000] (http://standardterms.edqm.eu)
Batch Instance
↸arrow indicates that this Medication resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via extension http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
Medication [documentation R4 R5 R6]
id: medication-actual-batch
fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51
- 33445
Definition: Stelbat Tablets, 20mg (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Batch
Lot Number: 33445
Manufacturing
Date: 2020-06
Release Date: 2019-09-08
Packaging Date: 2020-08
Quantity: 100100 tablets
Actual Yield: 4.8 kg
Utilization: Stability Study [C185328] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl) - Text: PPQ / Stability
Container
Closure System: 100 cc HDPE Bottle 2 g desiccant
Manufacturer
Found a parent (Medication/valueReference, id: medication-actual-batch fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-2 fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-3 fullUrl: urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: manufacturer
fullUrl: urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a
- AAA Pharmaceutical, Inc.
Identifier: 3010027650 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Pharmaceutical, Inc.
Type: Drug Product Manufacture [drug-product-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 681 Main Street, Lumberton, New Jersey, 08048, USA
Packager
Found a parent (Medication/valueReference, id: medication-actual-batch fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-2 fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-3 fullUrl: urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: packaging
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07
- MySite
Identifier: 3008816891 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: MySite
Type: Packaging [packaging] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
↸arrow indicates that this Medication resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via extension http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
Medication [documentation R4 R5 R6]
id: medication-actual-batch-2
fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc
- 33446
Definition: Stelbat Tablets, 20mg (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Batch
Lot Number: 33446
Manufacturing
Date: 2020-06
Release Date: 2019-09-08
Packaging Date: 2020-08
Quantity: 100050 tablets
Actual Yield: 4.8 kg
Utilization: Stability Study [C185328] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl) - Text: PPQ / Stability
Container
Closure System: 100 cc HDPE Bottle 2 g desiccant
Manufacturer
Found a parent (Medication/valueReference, id: medication-actual-batch fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-2 fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-3 fullUrl: urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: manufacturer
fullUrl: urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a
- AAA Pharmaceutical, Inc.
Identifier: 3010027650 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Pharmaceutical, Inc.
Type: Drug Product Manufacture [drug-product-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 681 Main Street, Lumberton, New Jersey, 08048, USA
Packager
Found a parent (Medication/valueReference, id: medication-actual-batch fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-2 fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-3 fullUrl: urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: packaging
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07
- MySite
Identifier: 3008816891 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: MySite
Type: Packaging [packaging] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
↸arrow indicates that this Medication resource points back to the parent MedicinalProductDefinition, instead of being linked forwards from it - via extension http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Extension-medication-definition-pq
Medication [documentation R4 R5 R6]
id: medication-actual-batch-3
fullUrl: urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06
- 33447
Definition: Stelbat Tablets, 20mg (MedicinalProductDefinition) id: medicinalproductdefinition-drug-product-dxpq-ex1
Batch
Lot Number: 33447
Manufacturing
Date: 2020-06
Release Date: 2019-09-08
Packaging Date: 2020-08
Quantity: 100125 tablets
Actual Yield: 4.8 kg
Utilization: Stability Study [C185328] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl) - Text: PPQ / Stability
Container
Closure System: 100 cc HDPE Bottle 2 g desiccant
Manufacturer
Found a parent (Medication/valueReference, id: medication-actual-batch fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-2 fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-3 fullUrl: urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: manufacturer
fullUrl: urn:uuid:0102bca4-46c1-a6bf-1025-cd403fee710a
- AAA Pharmaceutical, Inc.
Identifier: 3010027650 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Pharmaceutical, Inc.
Type: Drug Product Manufacture [drug-product-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 681 Main Street, Lumberton, New Jersey, 08048, USA
Packager
Found a parent (Medication/valueReference, id: medication-actual-batch fullUrl: urn:uuid:339b69fd-4ab1-a1e9-9ea5-1972ba2f6b51)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-2 fullUrl: urn:uuid:a9dfda53-734b-045f-7ae4-94a6281d53bc)
which is linked to this by resource.id
Found a parent (Medication/valueReference, id: medication-actual-batch-3 fullUrl: urn:uuid:c6f5fadd-62e6-3a01-93d9-b3b182f67d06)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: packaging
fullUrl: urn:uuid:378fbe5f-5926-3a5c-4c64-5428df877b07
- MySite
Identifier: 3008816891 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: MySite
Type: Packaging [packaging] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)