Good manufacturing practices guide for drug products (GUI-0001) - Summary

Related acts and regulations

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
  • labellers
  • testers
  • distributors
  • importers
  • wholesalers

In this guide

View complete guide

Download PDF (1 MB, 156 pages)

Details and history

  • Published: February 28, 2018
  • Implementation: October 1, 2018
  • Consulted: January 18, 2017 – April 18, 2017

For assistance

By email GMP_Questions_BPF@hc-sc.gc.ca

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