Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs (GUI-0119) - Summary

From: Health Canada


This document provides guidance for fabricating and packaging/labelling sterile drug products.

It is an annex to the current edition of the Good manufacturing practices guide for drug products (GUI-0001). It will help you understand and comply with good manufacturing practices (GMP) for sterile products.

The interpretations in this document have been adopted from those published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in Guide to Good Manufacturing Practice for Medicinal Products Annexes. 

Who this guide is for

This guide is for people who work with sterile drugs as:

  • fabricators
  • packagers
  • labellers
  • testers

In this guide

View complete guide

Download PDF (501 KB, 43 pages)

Details and history

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

For assistance

Contact us by email:

Service standards: We answer to mail within 10 business days. If we can't answer your question right away. We will send you an estimate date.

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: