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 – Batch Analysis PQ
Bundle bundle-batch-analysis-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:1b1b1b1b-1b1b-1b1b-1b1b-1b1b1b1b1b1b
Resource SubstanceDefinition:
Language: en
status: Active
manufacturer: Organization AAA Molybdenum Products, Inc.
Names
Name Stelbatolol Hydrochloride
Entry 2 - fullUrl = urn:uuid:2b2b2b2b-2b2b-2b2b-2b2b-2b2b2b2b2b2b
Resource PlanDefinition:
Metadata Title SPECIFICATION(S) FOR DRUG PRODUCT Subject Type MedicinalProductDefinition: identifier = http://example.org/identifiers/product#PROD-12345; combinedPharmaceuticalDoseForm = Tablet; route = Oral use Description Narrative description of specifications
PlanDefinition Action Title Specification(s) for Drug Product Code Overall set of actions PlanDefinition Sub-Action (Parent Action Title: Specification(s) for Drug Product) Title Release Code Timing Group Timing Code PlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/77e7020a-270c-6bed-2e55-28e9e942546cPlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/0d0ef4cf-242c-1cb1-81c4-c41837ee9a12PlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/c0f05343-5b98-6073-1a0f-873aaf4f59bcPlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/a3d4d23a-800a-684a-6a47-fcfe44e06041PlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/bb11322b-9470-4f13-91b5-c8a5253380ebPlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/e7e2fe59-5433-5cc0-84b1-d5f30032790cPlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/64972eb3-99ee-7eae-2f63-733e5ae84f71PlanDefinition Sub-Action (Parent Action Title: Release) Code Test Definition http://example-server.com/fhir/ObservationDefinition/6ce8ab6d-55e2-0412-5fb1-ab33763f30b1PlanDefinition Sub-Action (Parent Action Title: Specification(s) for Drug Product) Title End of shelf life Code Timing Group Timing Code PlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/d24ce3cd-213d-4935-97cf-8e2dd03721ecPlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/f77ba972-5ef8-a178-9a5f-fe7f54da7499PlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/f4a74fd3-876e-38ce-021f-04e5a8fb6a3fPlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/ef72eeb7-211a-3c16-8460-8725ca43584fPlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/6fa69a2d-5a9f-a391-76e6-bbdfba0b45eaPlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/43dbc2a3-00c4-6f79-6b11-63768b412aa3PlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/e582e504-36ec-3b50-4043-51bf1147124ePlanDefinition Sub-Action (Parent Action Title: End of shelf life) Code Test Definition http://example-server.com/fhir/ObservationDefinition/91391017-774b-5c77-93fa-642534278851Generated using version 0.5.4 of the sample-content-ig Liquid templates
Entry 3 - fullUrl = urn:uuid:3b3b3b3b-3b3b-3b3b-3b3b-3b3b3b3b3b3b
Resource ObservationDefinition:
Language: en
status: Active
code: Assay
method: Assay by UHPLC
Entry 4 - fullUrl = urn:uuid:4b4b4b4b-4b4b-4b4b-4b4b-4b4b4b4b4b4b
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 5 - fullUrl = urn:uuid:5b5b5b5b-5b5b-5b5b-5b5b-5b5b5b5b5b5b
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 6 - fullUrl = urn:uuid:6b6b6b6b-6b6b-6b6b-6b6b-6b6b6b6b6b6b
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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