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

Drug Establishment Licensing Bulletin 148, August 24, 2023

In a 2020 notice Health Canada informed stakeholders of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products Annex 1 Manufacture of Sterile Medicinal Products consultation. We also stated our intent to adopt the finalized annex within our Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119).

• Notice to stakeholders – Draft guidance document for consultation: Guide to Good Manufacturing Practice for Medicinal Products Annex 1: Manufacturing of sterile medicinal products

In September 2022, the PIC/S announced it had published the revised Guide to Good Manufacturing Practice for Medicinal Products Annex 1 Manufacture of Sterile Medicinal Products. This revised guide would come into force on August 25, 2023. The requirements outlined in lyophilization section 8.123 would come into force on August 25, 2024.

Health Canada's GUI-0119, an annex to the Good manufacturing practices guide for drug products (GUI-0001), provides guidance for fabricating and packaging/labelling sterile drugs. It will help you understand and comply with good manufacturing practices for sterile drugs.

We are adopting the updated recommendations for manufacturing sterile drugs in parallel with various international partners within the PIC/S, European Medicines Agency and World Health Organization. This will allow us to achieve greater international harmonization of compliance standards.

In Canada, the coming-into-force date is April 1, 2024, for drug establishment licence holders who fabricate and package/label sterile drugs. The requirements for lyophilization will come into force on August 25, 2024.

The updated GUI-0119 replaces the February 2018 version. The key changes are:

• conforms to the layout and wording of the PIC/S revised Annex 1
• incorporates a quality risk management approach
• provides guidance for manufacturing other products that are not intended to be sterile
• implements a contamination control strategy
• highlights specific requirements of the pharmaceutical quality system
• adds details to the following topics:
  • design and qualification of premises, equipment and utilities
  • training and qualification of personnel
  • production and specific technologies
  • environmental and process monitoring
  • quality control requirements

We will publish the updated GUI-0119 on August 31, 2023. If you have questions, please email us at hpil-consultation-ipsop@hc-sc.gc.ca.