Guide to validation – drugs and supporting activities (GUI-0029) - Summary
- Good manufacturing practices guide (GUI-0001)
- Cleaning validation guide (GUI-0028)
- Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
- Guidance Document: Addendum - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers
- Post-Notice of Compliance (NOC) Changes: Quality Document
- Process Validation: Gaseous Sterilization for Pharmaceuticals (GUI-0007)
- Process Validation: Irradiation Sterilization for Pharmaceuticals (GUI-0009)
- Process Validation: Moist Heat Sterilization for Pharmaceuticals (GUI-0010)
This document describes how to properly qualify and validate drug manufacturing processes, facilities, equipment, utilities and analytical methods.
Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.
Health Canada inspects establishments to assess their compliance with the Act and associated regulations. When conducting an inspection, Health Canada will use this document as a guide in assessing your compliance with GMP requirements.
Who this guide is for
These guidelines apply to the following types of drugs:
In this guide
- About this document
- General validation requirements
- Lifecycle approach to process validation
- 6.1 Phase 1: Process design
- 6.2 Phase 2: Process performance qualification (PPQ)
- 6.3 Phase 3: Ongoing process verification
- Change review
- Guidance for validation or qualification of supporting activities
Details and history
Published: June 29, 2021
Updated: June 29, 2021
Consulted: November 20, 2018 - February 20, 2019
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