Good manufacturing practices guidelines for active pharmaceutical ingredients (GUI-0104) - Summary

Overview

These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders.

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 we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements.

Who this guide is for

This guide is for people who work with drugs as:

• fabricators
• packagers (including re-packagers/re-labellers)
• labellers
• testers
• distributors
• importers
• wholesalers

In this guide

• About this document
  • 1. Purpose
  • 2. Scope
  • 3. Introduction
    • Checklist – GMP regulations by API activity
    • API manufacturing steps and GMP requirements
• About quality management
  • 4. Pharmaceutical quality system
    • Guiding principles
    • Quality risk management
    • Responsibilities of the quality unit(s)
    • Responsibilities for production activities
    • Self-inspection
    • Product quality review
• Guidance
  • 5. Regulations
    • C.02.002
    • C.02.002.1
    • Sale
      • C.02.003
      • C.02.003.1
      • C.02.003.2
    • Use in fabrication
      • C.02.003.3
    • Premises
      • C.02.004
    • Equipment
      • C.02.005
    • Personnel
      • C.02.006
    • Sanitation
      • C.02.007
      • C.02.008
    • Raw material testing
      • C.02.009
      • C.02.010
    • Manufacturing control
      • C.02.011
      • C.02.012
    • Quality control department
      • C.02.013
      • C.02.014
      • C.02.015
    • Packaging material testing
      • C.02.016
      • C.02.017
    • Finished product testing
      • C.02.018
      • C.02.019
    • Records
      • C.02.020
      • C.02.021
      • C.02.022
      • C.02.023
      • C.02.024
      • C.02.024.1
    • Samples
      • C.02.025
      • C.02.026
    • Stability
      • C.02.027
      • C.02.028
• Appendices
  • Appendix A – Glossary
    • Acronyms
    • Terms
  • Appendix B – References
    • Laws and regulations
    • Annexes to GUI-0104
      • Good manufacturing practices
      • Validation guidelines
      • Other related documents
      • International guidance documents
  • Appendix C – Crosswalk between GUI-0104 and ICH Q7 documents

View complete guide

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Details and history

• Published: February 10, 2022
• Implementation: February 10, 2022
• Consulted: December 31, 2018 – March 31, 2019

For assistance

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