- Compliance with the Quality Systems Approach to Pharmaceutical CGMPs Guidance, Second Edition
- Handbook / Manual / Guide by Compressed Gas Association, 07/01/2
- Category: CGA
This publication provides guidance on how a medical gas manufacturer can implement the quality systems approach to meet requirements of 21 CFR Parts 210 and 211. It is based on a review of the FDA's September 2006 Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations.