Consultation round for GUI-0046

Drug Establishment Licensing Bulletin 142, September 10, 2024

On this page

• About the consultation
• Overview of key changes
• How to participate

About the consultation

Health Canada has released Annex 17 to the Good manufacturing practices guide – Real time release testing and parametric release (GUI-0046) for a 45-day stakeholder consultation period. The consultation is from September 10, 2024 to October 24, 2024.

This guide is an annex to the Good manufacturing practices guide for drug products (GUI-0001). These guides are to be read together. They will help you understand and comply with Part C, Division 2, of the Food and Drug Regulations, which is about good manufacturing practices (GMP).

This revised guidance document contains new information with key changes listed below.

Overview of key changes

The revised guidance document has been edited to make it easier to understand.

We have also made changes in several sections to make the meaning clearer. For example, we:

• changed the title from

  Annex 17, Parametric Release (PIC/S) - Guide to Good Manufacturing Practice for Medicinal Products Annexes

  to

  Annex 17 to the Good manufacturing practices guide - Real time release testing and parametric release (GUI-0046)

  • this aligns the guidance with other newly revised annexes
• added a new section about real time release testing to align with the revised Annex 17 of the Guide to Good Manufacturing Practice for Medicinal Products Annexes by Pharmaceutical Inspection Cooperation Scheme (PIC/S)
• changed the title of Section 5, which covers parametric release, to "Parametric release and sterilisation"
• added a new sub-section about the sterilization process

We also added a reference section that also includes relevant references from other jurisdictions, along with their URLs.

How to participate

If you wish to participate, you may obtain the consultation package by emailing us at hpil-consultation-ipsop@hc-sc.gc.ca.

You may send your comments to hpil-consultation-ipsop@hc-sc.gc.ca by October 24, 2024. We will consider all comments when we finalize the guidance document.