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.
- Edition:
- 2nd
- Published:
- 07/01/2014
- Number of Pages:
- 16
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