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 - Manufacturing, substance

Bundle bundle-product-manufacturing-pq-ex2-sub of type collection

Entry 1 - fullUrl = urn:uuid:bf6b038b-1334-3dd4-a552-65c169e2265a

Resource PlanDefinition:

> Generated Narrative: PlanDefinition

> Resource PlanDefinition "manufacturingProcess-unlinked"

> Extension - Plan Document Reference PQ: See on this page: DocumentReference/74d4c070-6596-8252-8ad9-afa515a41feb

> Extension - History of Process PQ: This can be text about the history

> url: `http://example-server.com/fhir/PlanDefinition/bf6b038b-1334-3dd4-a552-65c169e2265a`

> type: Manufacturing Process (Pharmaceutical Plan Type Codes#manufacturing-process)

> status: ACTIVE

> subject: See on this page: SubstanceDefinition/c458791f-7cb8-428e-83f7-8a205f821152

> description: Narrative description of substance manufacturing process

> > goal

> > > id

> > > goal-control-pH

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - pH ()

> > priority: Critical (Goal Priority - example#critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | Long description of the acceptance criteria - pH must be in range 6.9 to 7.1 (Example Local Codes - Drug#pH "pH") | 6.9-7.1 pH

> > goal

> > > id

> > > goal-control-temp

> > category: Physical Property (Pharmaceutical Test Category Codes#C123456)

> > description: Controls - Temperature ()

> > priority: Non-critical (Goal Priority - example#non-critical)

> > ### Targets

> > - | Measure | Detail[x]
> > * | Long description of the control value - Temperature must be below 150°C (Example Local Codes - Drug#TEMP "Temperature") | ?-150

> > action

> > code: overall process (Manufacturing Step Codes#overall process "Overall Process")

> > > action

> > > Extension - Process Step Scale PQ: Production Scale (Details: http://terminology.hl7.org/CodeSystem/manufacturing-step-scale code PROD = 'Production Scale', stated as 'Production Scale')

> > > > Extension - Process Parameters PQ

> > > > > url

> > > > > `parameter`

> > > > value: Mix speed (Process Parameter Codes#SPEED)

> > > > > url

> > > > > `value`

> > > > value: 1500 rpm

Entry 2 - fullUrl = urn:uuid:82a39a18-91cf-a19d-76c1-a9e8bad9494c

Resource DeviceDefinition:

> Generated Narrative: DeviceDefinition

> Resource DeviceDefinition "82a39a18-91cf-a19d-76c1-a9e8bad9494c"

> ### DeviceNames

> - | Name | Type
> * | Rotating Impeller with 1.5mm screen | REGISTEREDNAME

> ### Properties

> - | Type | Value[x]
> * | Maximum Speed (Device Property Codes#Maximum Speed) | 5000 RPM

Entry 3 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41feb

Resource DocumentReference:

> Generated Narrative: DocumentReference

> Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41feb" Version "1" Updated "2023-01-12 17:57:08+0000"

> Information Source: #n4xHiP0iat7deVDt!

> identifier: `http://example.org/fhir/identifier/document`/FLOW-001

> status: CURRENT

> type: Process Flow Diagram (Diagram Type Codes#ProcessFlowDiagram)

> > content

> > ### Attachments

> > - | Url
> > * | https://example.org/docStore/flow-001

Entry 4 - fullUrl = urn:uuid:74d4c070-6596-8252-8ad9-afa515a41fef

Resource DocumentReference:

> Generated Narrative: DocumentReference

> Resource DocumentReference "74d4c070-6596-8252-8ad9-afa515a41fef"

> status: CURRENT

> > content

> > ### Attachments

> > - | Url
> > * | https://www.accumulus.org/wp-content/uploads/2022/05/Accumulus_Logo_horizontal.png

Entry 5 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821152

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821152"

> manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d

> ### Names

> - | Name
> * | Stelbatolol

Entry 6 - fullUrl = urn:uuid:9fe98cfa-9245-8313-0fc5-d15e613b5d6d

Resource Organization:

> Generated Narrative: Organization

> Resource Organization "9fe98cfa-9245-8313-0fc5-d15e613b5d6d"

> identifier: `urn:oid:2.16.840.1.113883.4.82`/3003040516

> active: true

> type: Drug Substance Manufacture (Pharmaceutical Organization Type Codes#drug-substance-manufacture)

> name: AAA Molybdenum Products, Inc.

> ### Contacts

> - | Address
> * | 7233 W 116th Pl Ste C Broomfield Colorado 80020 USA

Entry 7 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821153

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821153"

> manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d

> ### Names

> - | Name
> * | Stelbatosubstance

Entry 8 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821154

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821154"

> ### Names

> - | Name
> * | Resultothane

Entry 9 - fullUrl = urn:uuid:c458791f-7cb8-428e-83f7-8a205f821155

Resource SubstanceDefinition:

> Generated Narrative: SubstanceDefinition

> Resource SubstanceDefinition "c458791f-7cb8-428e-83f7-8a205f821155"

> manufacturer: See on this page: Organization/9fe98cfa-9245-8313-0fc5-d15e613b5d6d

> ### Names

> - | Name
> * | Processohol