Consultation for GUI-0080

Drug Establishment Licensing Bulletin 165, February 14, 2024

On this page

• About the consultation
• Overview of key changes
• Overview of items under review
• How to participate

About the consultation

Health Canada has opened Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080) for consultation. The 90-day consultation period is from February 14 to May 15, 2024.

This revised guidance document contains new information.

Overview of key changes

We've revised the guidance document to make it clearer and align it with current industry practices. We are looking for your feedback on the following important changes from the previous version:

• language and formatting updates
• guidance on the extra-jurisdictional certificate of compliance (CoC) exchange process
• guidelines for managing alternate sample retention site within GUI-0080 (intended to replace Guidance document alternate sample retention site guidelines (GUI-0014))
• guidance on the process for risk monitoring and reassessing foreign buildings with non-compliance ratings
• considerations for managing foreign building campuses during a DEL amendment application
• guidance on importers' responsibilities aligned with the Food and Drug Regulations
• guidance on our approach to conducting foreign remote inspections
• considerations for accepting remote inspection reports from regulatory or qualified authority
• updates to the list of recommended GMP evidence

We will consider this input in the final publication of GUI-0080.

Overview of items under review

We're continuing to review 3 additional items related to this GUI-0080 update:

• the acceptability of ISO standards as GMP evidence to support foreign buildings performing sterilization of packaging materials performed by foreign buildings
• the current 3-year validity period of inspection reports
• our risk-based approach to assigning new evidence required by (NERBY) dates

As this work is ongoing, we welcome additional input on the items we're reviewing. Your input could include examples of how this information could help ensure an adequate supply of drugs for the Canadian market.

Please provide your input in the comment form described in the "how to participate" section.

How to participate

Email us to ask for the consultation package and submit your comments by May 15, 2024. We will consider all comments when we finalize the guidance document.

Email: hpil-consultation-ipsop@hc-sc.gc.ca

The consultation package includes the:

• draft guidance document
• comment form