Pharmaceutical Quality (Industry)
1.0.0 - STU1
Pharmaceutical Quality (Industry)
1.0.0 - STU1
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
Bundle bundle-drug-product-pq-ex1 of type collection
Entry 1 - fullUrl = urn:uuid:a1694a7b-aafa-4cbe-8135-c788a9a4d3d5
Resource Composition:
Generated Narrative: Composition
Resource Composition "a1694a7b-aafa-4cbe-8135-c788a9a4d3d5"
status: FINAL
type: Product Note - Drug Components ()
date: 2023-10-01
author: See on this page: Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d
title: 3.2.P.2.1.1 - Components of the Drug Product
Entry 2 - fullUrl = urn:uuid:a1694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource Composition:
Generated Narrative: Composition
Resource Composition "a1694a7a-aafa-4cbe-8135-c788a9a4d3d5"
Profile: Composition - Drug PQ
status: FINAL
type: Product Note - Formulation Development ()
date: 2023-10-01
author: See on this page: Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d
title: 3.2.P.2.2.1 - Formulation Development
Entry 3 - fullUrl = urn:uuid:a1694a8a-aafa-4cbe-8135-c788a9a4d3d5
Resource Composition:
Generated Narrative: Composition
Resource Composition "a1694a8a-aafa-4cbe-8135-c788a9a4d3d5"
Profile: Composition - Drug PQ
status: FINAL
type: Product Note - Summary for Risk of Impurities ()
date: 2023-10-01
author: See on this page: Organization/9fe98cfa-9246-8313-0fc5-d15e613b5d6d
title: 3.2.P.2.2.4 - Summary for Risk of Impurities
Entry 4 - fullUrl = urn:uuid:a0694a7a-aafa-4cbe-8135-c788a9a4d3d5
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition
Resource MedicinalProductDefinition "a0694a7a-aafa-4cbe-8135-c788a9a4d3d5"
comprisedOf: See on this page: ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44
Names
ProductName Stalbatolol characteristic
type: Physicochemical properties (Example Local Codes - Drug#physicochemical)
value: Product properties with cross reference to other dossier sections as 3.2.P.5.1 Consider parameters relevant to the performance of the drug product, such as pH, ionic strength, dissolution, redispersion, reconstitution, particle size distribution, aggregation, polymorphism, rheological properties, biological activity or potency, and/or immunological activity. Any properties which are not included in the product specification, with explanation of parameter control and relevant studies. If applicable refer to relevant compendia monograph ()
characteristic
type: pH (Example Local Codes - Drug#pH)
value: 7.0
characteristic
type: Ionic Strength (Example Local Codes - Drug#ionic-strength)
value: 23 mg/mL
Entry 5 - fullUrl = urn:uuid:1531c777-50c3-047d-2798-de3d001d2c44
Resource ManufacturedItemDefinition:
Generated Narrative: ManufacturedItemDefinition
Resource ManufacturedItemDefinition "1531c777-50c3-047d-2798-de3d001d2c44"
Profile: ManufacturedItemDefinition - Drug PQ
status: ACTIVE
name: Stelbatolol 5mg tablet
manufacturedDoseForm: ()
property
type: Overage by mass (%) (Manufactured Item Property - example#overage-by-mass)
value: 5 %
property
type: Overage reason (Manufactured Item Property - example#overage-reason)
value: Overage is necessary because... ()
Entry 6 - fullUrl = urn:uuid:9fe98cfa-9246-8313-0fc5-d15e613b5d6d
Resource Organization:
Generated Narrative: Organization
Resource Organization "9fe98cfa-9246-8313-0fc5-d15e613b5d6d"
identifier:
urn:oid:2.16.840.1.113883.4.82/3003040516active: true
type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)
name: AAA Molybdenum Products, Inc.
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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