Share your views: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

From: Health Canada

Health Canada is seeking feedback on our revised guidance document How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).

The consultation period is for 90 days, from February 14, to May 15, 2024.

Join in: how to participate

Send us an email to hpil-consultation-ipsop@hc-sc.gc.ca to ask for the consultation package and submit comments by May 15, 2024. We will consider all comments when we finalize the guidance document.

The consultation package includes the:

• draft guidance document
• comment form

Who is the focus of this consultation

We will engage with the following:

• drug establishment license (DEL) holders who want to list and maintain a foreign building on their DEL
• Canadian groups or associations that represent DEL holders
• Canadian groups or associations that have an interest in the regulation of safe and effective medicines

Key items for consultation

We've revised the guidance document to make it clearer and to align with current industry practices. We're looking for your feedback on the changes we made. These include:

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

The input gathered through this process will be considered in the final publication of GUI-0080.

Overview of items under review

Health Canada is continuing to evaluate 3 additional items related to this update:

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

As the work related to these projects is ongoing, Health Canada welcomes your input on these 3 items. Examples showing how this information could help ensure an adequate supply of drugs for the Canadian market are welcomed. Please provide your input in the comment form described in the "Join in: how to participate" section.

Related information

Current published version of GUI-0080:

• Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

Contact us

Health Product Inspection and Licensing Division
Health Product Compliance Directorate
13th Fl, Jeanne Mance Bldg
200 Eglantine Driveway, Tunney's Pasture
Address Locator # 1913D
Ottawa ON K1A 0K9
Email: hc.hpil.consultation-ipsop.sc@canada.ca