Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot
This page is part of the Pharmaceutical Quality (Industry) (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Bundle bundle-container-closure-system-pq-ex2-sub of type collection
Entry 1 - fullUrl = urn:uuid:878c2849-792c-6469-21a2-c2b920930962
Resource SubstanceDefinition:
Generated Narrative: SubstanceDefinition
Resource SubstanceDefinition "878c2849-792c-6469-21a2-c2b920930962"
Names
Name Stelbatolol
Entry 2 - fullUrl = urn:uuid:b107a2ba-32d8-0124-7855-4096057c52a9
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition
Resource PackagedProductDefinition "b107a2ba-32d8-0124-7855-4096057c52a9"
description: Any textual comments that describe the sum of container closure system (CCS) components that together contain and protect the dosage form or drug substance.
packaging
type: Bag (Packaging Type#100000073493)
material: Low Density PolyEthylene (Package Material#200000003216)
property
type: Quality Specification (CodeSystem - Package Property#Quality Specification)
value: Complies with FDA 21 CFR 177.1520 (c) 2.2 (olefin polymers) ()
property
type: Quality Specification (CodeSystem - Package Property#Quality Specification)
value: Complies with Commission Regulation (EU) No. 10/2011 including its amendments EU 321/2011, EU 1282/2011, EU 1183/2012, EU 202/2014 and EU 2015/174 Complies with Ph. Eur. 3.2.2 ()
containedItem
Items
Reference See above (ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44)
Entry 3 - fullUrl = urn:uuid:b107a2ba-32d8-0124-7855-4096057c52b9
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition
Resource PackagedProductDefinition "b107a2ba-32d8-0124-7855-4096057c52b9"
description: Any textual comments that describe the sum of container closure system (CCS) components that together contain and protect the dosage form or drug substance.
packaging
type: Bottle (Packaging Type#100000073497)
material: High Density PolyEthylene (Package Material#200000003215)
containedItem
Items
Reference See above (ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44)
Entry 4 - 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
manufacturedDoseForm: ()
Entry 5 - fullUrl = urn:uuid:f26b997a-3ab9-7552-a6cc-fd771d1f1863
Resource Ingredient:
Generated Narrative: Ingredient
Resource Ingredient "f26b997a-3ab9-7552-a6cc-fd771d1f1863"
status: ACTIVE
for: See above (ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44)
role: ()
substance
Codes
Reference See above (SubstanceDefinition/878c2849-792c-6469-21a2-c2b920930962: WizzoSubstance)
Entry 6 - fullUrl = urn:uuid:2138e4c7-22b8-4c56-2d28-6c077648763f
Resource PlanDefinition:
Generated Narrative: PlanDefinition
Resource PlanDefinition "2138e4c7-22b8-4c56-2d28-6c077648763f"
url:
http://example-server.com/fhir/PlanDefinition/2138e4c7-22b8-4c56-2d28-6c077648763ftitle: Specification and Analytical Procedures
type: Workflow Definition (PlanDefinitionType#workflow-definition; CodeSystem - Plan Type#container-specification "Container Specification")
status: ACTIVE
subject: See above (PackagedProductDefinition/b107a2ba-32d8-0124-7855-4096057c52a9)
description: Packaging components are sampled, tested, and examined for conformance with written specifications. The specification for the primary packaging component are provided in Table 1.
action
title: Container Specification
code: Container Specification (CodeSystem - Specification Type#Container Specification)
Actions
Description Code Definition[x] Container Type Test () ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958524Material Identification Test () ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958525Material Conformity Test () ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958535
Entry 7 - fullUrl = urn:uuid:64525b3c-5134-448a-9d19-939ce1958524
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "64525b3c-5134-448a-9d19-939ce1958524"
url:
http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958524title: Visual Inspection
status: ACTIVE
code: VisualInspection (CodeSystem - Example Local Codes - Drug#VisualInspection)
QualifiedValues
Extension
Entry 8 - fullUrl = urn:uuid:64525b3c-5134-448a-9d19-939ce1958525
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "64525b3c-5134-448a-9d19-939ce1958525"
url:
http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958525title: Infrared Spectroscopy
status: ACTIVE
code: InfraredSpectroscopy (CodeSystem - Example Local Codes - Drug#InfraredSpectroscopy)
QualifiedValues
Extension
Entry 9 - fullUrl = urn:uuid:64525b3c-5134-448a-9d19-939ce1958535
Resource ObservationDefinition:
Generated Narrative: ObservationDefinition
Resource ObservationDefinition "64525b3c-5134-448a-9d19-939ce1958535"
url:
http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958535title: Supplier Certificate of Analysis
status: ACTIVE
code: SupplierCertificateofAnalysis (CodeSystem - Example Local Codes - Drug#SupplierCertificateofAnalysis)
QualifiedValues
Extension
IG © HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharm-quality#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-18
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