Annex 1 to the Good Manufacturing Practices Guide – Manufacture of Sterile Drugs (GUI-0119) – Summary – Canada.ca

Health Canada’s Annex 1 to the Good Manufacturing Practices Guide for Manufacture of Sterile Drugs (GUI-0119) will be implemented 01 October 2018. This document replaces “Sterile Products” section of Good Manufacturing Practices Guidelines, 2009 Edition, Version 2, March 4, 2011. This document provides interpretation and guidance for pharmaceutical, radiopharmaceutical, biological and veterinary sterile drug fabricators and packagers.

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