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 PlanDefinition: PlanDefinition - Drug - example, manufacturing plan

Active as of 2024-05-08

Generated Narrative: PlanDefinition

Resource PlanDefinition "plandefinition-drug-pq-ex2-manufacturing-plan"

Profile: PlanDefinition - Drug PQ

Tag: http://terminology.hl7.org/CodeSystem/v3-ObservationValue

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

url: `http://example-server.com/fhir/PlanDefinition/plandefinition-drug-pq-ex2-manufacturing-plan`

identifier: URI/urn:oid:2.16.840.1.113883.4.642.40.41.34.2

version: 1.0.0

title: Process 1.0

type: Workflow Definition (PlanDefinitionType#workflow-definition; Pharmaceutical Plan Type Codes#manufacturing-process "Manufacturing Process")

status: active

subject: MedicinalProductDefinition/medicinalproductdefinition-drug-product-pq-ex1

date: 2024-05-08 12:53:57+0000

publisher: HL7 International / Biomedical Research and Regulation

contact: HL7 International - Biomedical Research and Regulation: http://www.hl7.org/Special/committees/rcrim

description: Narrative description of manufacturing process (5)

jurisdiction: World (m49.htm#001)

> 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]
> * | 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-water-content

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

> description: Controls - Water Content ()

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

> ### Targets

> - | Measure | Detail[x]
> * | Under 2% (Example Local Codes - Drug#WaterContent "Water content") | ?-2

> goal

> > id

> > goal-control-particle-size

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

> description: Controls - Particle Size ()

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

> ### Targets

> - | Measure | Detail[x]
> * | Under 200 microns (Example Local Codes - Drug#particle-size "Particle Size") | ?-200