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
Language: en
Profile: Bundle – Drug Stability PQ
Bundle bundle-drug-stability-pq-ex1-prod of type collection
Entry 1 - fullUrl = http://example.com/SubstanceDefinition/substance-drug-pq-ex1
Resource Substance:
Language: en
Profile: Substance - Drug PQ
Medication Manufacturing Batch
- manufacturingDate: 2019-09-07
- batchQuantity: 5 kg
- batchUtilization: Development
- assignedManufacturer: Organization AAA Molybdenum Products, Inc.
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: CAT1
instance: false
Codes
Concept Substance
Entry 2 - fullUrl = http://example.com/SpecimenDefinition/specimendefinition-drug-pq-ex1
Resource SpecimenDefinition:
Language: en
Profile: SpecimenDefinition - Drug PQ
status: Active
typeTested
preference: Preferred
Handlings
Instruction 25°C/60% RH
Entry 3 - fullUrl = http://example.com/Substance/substance-drug-pq-ex1
Resource Substance:
Language: en
Profile: Substance - Drug PQ
Medication Manufacturing Batch
- manufacturingDate: 2019-09-07
- batchQuantity: 5 kg
- batchUtilization: Development
- assignedManufacturer: Organization AAA Molybdenum Products, Inc.
Extension - Batch Release Date PQ: 2019-09-08
Extension - Batch Retest Date PQ: 2022-09-08
Extension - Actual Yield PQ: 4.8 kg
identifier: CAT1
instance: false
Codes
Concept Substance
Entry 4 - fullUrl = http://example.com/Specimen/specimen-drug-pq-ex1
Resource Specimen:
Language: en
Profile: Specimen - Drug PQ
Collections
Collected[x] 2020-12-01 processing
description: No storage
processing
description: 25°C/60% RH
Entry 5 - fullUrl = http://example.com/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol
Resource PlanDefinition:
Metadata Title Stability Monitoring Program Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use Description Narrative description of Stability Study
Type Stability Study Protocol PlanDefinition Action Title Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg PlanDefinition Sub-Action (Parent Action Title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg) Title Long-Term Description 25°C/60% RH
PlanDefinition Sub-Action (Parent Action Title: Long-Term) Title Initial Timing Once PlanDefinition Sub-Action (Parent Action Title: Initial) Title XYZ Definition http://example-server.com/fhir/ActivityDefinition/4bfe1ee8-91ed-5c1b-3045-c749bb9d1d90Generated using version 0.5.4 of the sample-content-ig Liquid templates
Entry 6 - fullUrl = http://example.com/ActivityDefinition/activitydefinition-test-drug-pq-ex1
Resource ActivityDefinition:
Metadata Title Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ. Generated using version 0.5.4 of the sample-content-ig Liquid templates
Entry 7 - fullUrl = http://example.com/ObservationDefinition/accelerated40X
Resource ObservationDefinition:
Language: en
status: Active
code: Battery of tests 'X' at 40°C/75% RH
Entry 8 - fullUrl = http://example.com/DiagnosticReport/diagnosticreport-analysis-drug-pq-stability-prod
Resource DiagnosticReport:
Language: en
Profile: DiagnosticReport - Analysis Drug PQ
Stability Study Report - 18 months
When For 2020-12 Performer Organization AAA Molybdenum Products, Inc. Identifier https://eudract.europa.eu/example/identifier/ABC1234Report Details
Code Value Flags When For Test Components - Long-term 25C etc - Initial (XYZ) Final 2023-01-01 12:00:00+0000 The samples have been assessed for initial period; no shelf life determined.
Entry 9 - fullUrl = http://example.com/Observation/observation-test-result-longterm25c-initial-1
Resource Observation:
Language: en
Profile: Observation - Test Result Drug PQ
Triggered by: Example of ActivityDefinition - Test for test set: Long-term - 25°C/60% RH - XYZ.
status: Final
code: Test Components - Long-term 25C etc - Initial (XYZ)
subject: Medication
effective: 2023-01-01 12:00:00+0000
performer: Organization AAA Molybdenum Products, Inc.
specimen: Specimen
hasMember:
Entry 10 - fullUrl = http://example.com/Organization/organization-drug-pq-ex1
Resource Organization:
Language: en
Profile: Organization - Drug PQ
identifier: FDA Establishment Identifier/3003040516
active: true
type: Drug Substance Manufacture
name: AAA Molybdenum Products, Inc.
Contacts
Address 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
Entry 11 - fullUrl = http://example.com/Organization/organization-drug-pq-ex1
Resource Organization:
Language: en
Profile: Organization - Drug PQ
identifier: FDA Establishment Identifier/3003040516
active: true
type: Drug Substance Manufacture
name: AAA Molybdenum Products, Inc.
Contacts
Address 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
Entry 12 - fullUrl = http://example.com/Organization/organization-drug-pq-ex1
Resource Organization:
Language: en
Profile: Organization - Drug PQ
identifier: FDA Establishment Identifier/3003040516
active: true
type: Drug Substance Manufacture
name: AAA Molybdenum Products, Inc.
Contacts
Address 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA
IG © 2023+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.pharm-quality#1.0.0 based on FHIR 5.0.0.
Generated
2026-05-10
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