Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

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-ballot 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, stability study protocol

Active as of 2024-02-21

Generated Narrative: PlanDefinition

Resource PlanDefinition "plandefinition-drug-pq-ex5-stability-study-protocol"

Profile: PlanDefinition - Drug PQ

StructureDefinition Work Group: brr

url: http://hl7.org/fhir/uv/pharm-quality/PlanDefinition/plandefinition-drug-pq-ex5-stability-study-protocol

version: 1.0.0-ballot

title: Stability Monitoring Program

type: Stability Study Protocol (planType#1244588)

status: active

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

date: 2024-02-21 17:36:48+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 Stability Study

jurisdiction: World (m49.htm#001)

action

title: Stability Test Protocol for Long-term and Accelerated Storage of Stelbat Tablets, 20 mg

action

title: Long-Term

description: 25°C/60% RH

action