Canada: Revised versions of drug good manufacturing practices (GMP) documents are available
On February 28, 2018, the Health Products Compliance Directorate posted four drug good manufacturing practices (GMP) documents to the Health Canada website. These documents are:
- Good manufacturing practices guide for drug products (GUI-0001),
- Risk classification guide for drug good manufacturing practices observations (GUI-0023),
- Good manufacturing practices for medical gases (GUI-0031), and
- Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119).
GUI-0001, GUI-0023, and GUI-0031 are revised versions of currently posted documents and GUI-0119 is a new document to replace the sterile products section of GUI-0001. These documents, except for GUI-0023, have an implementation date of October 1, 2018.
GUI-0023 will be implemented effective immediately as it will help you better understand how Health Canada currently assigns the risk rating to GMP inspection findings and the compliance rating for a GMP inspection. There are important changes in this guide as it relates to lower risk products and activities.
These documents have been updated to:
- address emerging issues such as increased reliance on foreign fabricators, packagers/labellers, and testers, and emerging trends such as data integrity,
- incoporate additional sample observations,
- help the medical gas industry comply with regulations,
- help industry comply with the regulations as they relate to sterile drugs, and
- be reformatted using plain language principles in accordance with new Canada.ca requirements, soon to be in effect.
Health Canada will host a series of webinars to review the revised guidance documents, highlight key changes and to answer any related questions. You can expect to receive invitations in the near future to attend webinars scheduled for:
- Thursday, March 29, 2018 on Good manufacturing practices for medical gases (GUI-0031), and
- May/June 2018 on the other three guidance documents (GUI-0001, GUI-0023, and GUI-0119).
Source: Health Product Inspection and Licensing Division