
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Health Canada recently announced the release of 5 draft guidance documents for a 90-day consultation period ending April 18, 2017.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.
Contact:
Dell Tech Laboratories
info@delltech.com
519-858-5021
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.
www.delltech.com
Recommended Posts