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

## 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

> > - | Description | Code | Definition[x]
> > * | Container Type | Test () | http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958524
> > * | Material Identification | Test () | http://example-server.com/fhir/ObservationDefinition/64525b3c-5134-448a-9d19-939ce1958525
> > * | Material Conformity | Test () | 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
> * |