Pharmaceutical Quality (Industry)
1.0.0 - STU1 International flag

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

Example Bundle: Example: Bundle - Container Closure System, substance

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 (Package Property Codes#Quality Specification)

value: Complies with FDA 21 CFR 177.1520 (c) 2.2 (olefin polymers) ()

property

type: Quality Specification (Package Property Codes#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 on this page: 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 on this page: 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 on this page: ManufacturedItemDefinition/1531c777-50c3-047d-2798-de3d001d2c44

role: ()

substance

Codes

-Reference
*See on this page: 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/2138e4c7-22b8-4c56-2d28-6c077648763f

title: Specification and Analytical Procedures

type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#container-specification "Container Specification")

status: ACTIVE

subject: See on this page: 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 (Specification Type - example#Container Specification)

Actions

-DescriptionCodeDefinition[x]
*Container TypeTest ()http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958524
*Material IdentificationTest ()http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958525
*Material ConformityTest ()http://example-server.com/fhir/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-9d19-939ce1958524

title: Visual Inspection

status: ACTIVE

code: VisualInspection (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-9d19-939ce1958525

title: Infrared Spectroscopy

status: ACTIVE

code: InfraredSpectroscopy (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-9d19-939ce1958535

title: Supplier Certificate of Analysis

status: ACTIVE

code: SupplierCertificateofAnalysis (Example Local Codes - Drug#SupplierCertificateofAnalysis)

QualifiedValues

-Extension
*