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Health Canada recently announced the release of 5 draft guidance documents for a 90-day consultation period ending April 18, 2017.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 specialty chemical
industry in Canada, the USA, Europe, and Asia for the last 40 years.
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