Canadian GMP Guidelines GUI-0001 2018

This guideline on Good Manufacturing Practices (GMP) pertain to Division 2, Part C of the Food and Drug Regulations. The guidelines apply to pharmaceutical, radiopharmaceutical, biological, and veterinary drugs and were developed by Health Canada in consultation with stakeholders.

These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements.

Date issued: February 28, 2018 Date of implementation: October 1, 2018 Replaces: Good Manufacturing Practices (GMP) Guidelines – 2009 Edition, version 2 (March 4, 2011)