Regulatory Update: new GMP and DEL Guidance Documents
By: Teri Jenner, Manager Regulatory Affairs Group, email
Health Canada recently announced the release of 5 draft guidance documents for a 90-day consultation period ending April 18, 2017.
- GUI-0001: Good manufacturing practices guide for drug products
- GUI-0023: Risk classification guide for drug good manufacturing practices observations
- GUI-0031: Good manufacturing practices for medical gases
- GUI-0080: How to demonstrate foreign building compliance with drug good manufacturing practices
- GUI-0119: Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs
For a complete overview of the changes in each of the documents please see the following Notice to Stakeholders.