Cleaning validation guide (GUI-0028) - Summary

Overview

This document provides guidance on cleaning validation. It will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations).

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 Food and Drugs Act and associated regulations. When conducting an inspection, Health Canada will use this document as a guide in assessing your compliance with good manufacturing practices requirements.

Who this guide is for

This guide addresses special considerations and issues when validating cleaning procedures for equipment used to fabricate and package:

• active pharmaceutical ingredients (APIs)
• pharmaceuticals
• radiopharmaceuticals
• biological drugs
• veterinary drugs

It covers validation of equipment cleaning for:

• the removal of residues associated with products used in the previous production run, such as active ingredients, breakdown or by-products of concern, intermediates, residues of cleaning agents, and processing agents
• the control of potential microbial contaminants

In this guide

• About this document
  • 1. Purpose
  • 2. Scope
  • 3. Introduction
• Guidance
  • 4. Principles
    • 4.1 About safe threshold values
  • 5. Applying QRM principles to control cross-contamination risks
  • 6. Cleaning validation master plan
  • 7. Cleaning validation lifecycle approach
    • 7.1 Phase 1 - Cleaning process design and development
      • 7.1.1 Control of manual cleaning processes
      • 7.1.2 Control of automated cleaning processes
    • 7.2 Phase 2 - Cleaning process qualification
      • 7.2.1 Release of equipment
    • 7.3 Phase 3 - Ongoing monitoring
      • 7.3.1 Change control and requalification
      • 7.3.2 Introducing new products to a facility
  • 8. Analytical and sampling methods
  • 9. Assessment of cleaning
    • 9.1 Visual inspection
    • 9.2 Equipment sampling
      • 9.2.1 Direct surface sampling (swab/wipe method)
      • 9.2.2 Rinse sampling
      • 9.2.3 Placebo sampling
  • 10. Establishing limits
  • 11. Microbiological controls
  • 12. General equipment cleaning considerations
    • 12.1 Cleaning agents
    • 12.2 Last rinse
    • 12.3 Dedicated equipment and facilities
  • 13. Additional considerations for cleaning of API production equipment
  • 14. Additional considerations for cleaning validation of biotechnology processes
• Appendices
  • Appendix A - Prevention of cross-contamination
  • Appendix B - Glossary
    • Acronyms
    • Terms
  • Appendix C – References
    • Laws and regulations
    • Health Canada guidance documents
    • International guidance documents
    • Other related documents

View complete guide

Download PDF (1 MB, 37 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

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