Guide to validation – drugs and supporting activities (GUI-0029) - Summary

Overview

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:

• pharmaceutical
• radiopharmaceutical
• biological
• veterinary

In this guide

• About this document
  1. Purpose
  2. Scope
  3. Introduction
• Guidance
  4. Principles
  5. General validation requirements
  6. Lifecycle approach to process validation
     1. 6.1 Phase 1: Process design
     2. 6.2 Phase 2: Process performance qualification (PPQ)
        1. 6.2.1 Protocol
        2. 6.2.2 Number of process qualification batches
        3. 6.2.3 Challenge plans
        4. 6.2.4 Distinct manufacturing step requirements
        5. 6.2.5 Sampling and testing plan requirements
        6. 6.2.6 Acceptance Criteria
        7. 6.2.7 Final report
        8. 6.2.8 Continuous process verification
     3. 6.3 Phase 3: Ongoing process verification
  7. Change review
  8. Guidance for validation or qualification of supporting activities
     1. 8.1 Facility, equipment and utility qualification
     2. 8.2 Analytical Method Validation
     3. 8.3 Computer System Validation
     4. 8.4 Packaging Validation
     5. 8.5 Cleaning Validation
• Appendices
  • Appendix A: Special concerns for solid dose products
    • Uniformity
    • Dissolution
  • Appendix B: Glossary
    • Acronyms
    • Terms
  • Appendix C: References

View complete guide
Download PDF (1.6 MB, 41 pages)

Details and history

Published: June 29, 2021

Updated: June 29, 2021

Consulted: November 20, 2018 - February 20, 2019

Part of topic(s): Guidance on legislation, [other relevant topic or content]

For assistance

By email hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca

Service standards: We answer to mail within 10 business days. If we can't answer your question right away we will send you an estimate date.