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 substance

The HTML rendering below shows a synthetic Quality data example for Common Technical Document (CTD) Module 3: Quality, section 3.2.S.4 Control of Drug Substance, subsection 3.2.S.4.4 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-substance-batch-info-pq-ex1
Profile: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Bundle-drug-substance-batch-info-pq
Type: collection
Batch Information - Substance, on Stelbatolol

Subjects of Batch Information

Found a parent (Substance/code, id: substance-dxpq-ex1 fullUrl: urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-2 fullUrl: urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
which is linked to this by resource.id
Found a parent (Substance/code, id: actual-batch-substance-3 fullUrl: urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7)
which is linked to this by resource.id
Substance - Stelbatolol [documentation R4 R5 R6]
id: substance1
fullUrl: urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130
Name: Stelbatolol
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1 fullUrl: urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2 fullUrl: urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3 fullUrl: urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Batch Instance
Substance - CAT1 [documentation R4 R5 R6]
id: substance-dxpq-ex1
fullUrl: urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1
Instance: true
Identifier: CAT1
Definition: Stelbatolol (SubstanceDefinition) id: substance1
Manufacturing
Date: 2020-01
Release Date: 2019-09-08
Retest Date: 2022-09-08
Quantity: 120 kg
Actual Yield: 4.8 kg
Utilization: Commercial [C133990] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl) - Text: Production
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1 fullUrl: urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2 fullUrl: urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3 fullUrl: urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Manufacturing Process
Display: Process 1.1
Substance - CAT2 [documentation R4 R5 R6]
id: actual-batch-substance-2
fullUrl: urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4
Instance: true
Identifier: CAT2
Definition: Stelbatolol (SubstanceDefinition) id: substance1
Manufacturing
Date: 2020-02
Release Date: 2019-09-08
Retest Date: 2022-09-08
Quantity: 120 kg
Actual Yield: 4.8 kg
Utilization: Commercial [C133990] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl) - Text: Production
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1 fullUrl: urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2 fullUrl: urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3 fullUrl: urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA
Substance - CAT3 [documentation R4 R5 R6]
id: actual-batch-substance-3
fullUrl: urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7
Instance: true
Identifier: CAT3
Definition: Stelbatolol (SubstanceDefinition) id: substance1
Manufacturing
Date: 2020-03
Release Date: 2019-09-08
Retest Date: 2022-09-08
Quantity: 120 kg
Actual Yield: 4.8 kg
Utilization: Commercial [C133990] (http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl) - Text: Production
Manufacturer
Found a parent (SubstanceDefinition/manufacturer, id: substance1 fullUrl: urn:uuid:8dae93e0-048d-35a4-71ea-7c603184a130)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: substance-dxpq-ex1 fullUrl: urn:uuid:87ef899b-14dd-26b7-7416-7ec1d01b62a1)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-2 fullUrl: urn:uuid:6412c5d4-1b7d-8405-85dc-75dbaa300ea4)
which is linked to this by resource.id
Found a parent (Substance/valueReference, id: actual-batch-substance-3 fullUrl: urn:uuid:ef17cff1-6586-a4a4-9168-2602140548d7)
which is linked to this by resource.id
Organization [documentation R4 R5 R6]
id: substance-manufacturer
fullUrl: urn:uuid:3d399cbc-244e-9b5f-838b-b7daa0489330
- AAA Molybdenum Products, Inc.
Identifier: 3003040516 (urn:oid:2.16.840.1.113883.4.82)
Active: true
Name: AAA Molybdenum Products, Inc.
Type: Drug Substance Manufacture [drug-substance-manufacture] (http://terminology.hl7.org/CodeSystem/pharmaceutical-organization-type)
Contact
Address: 7233 W 116th Pl, Ste C, Broomfield, Colorado, 80020, USA