Description
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.
Product Details
- Edition:
- 2nd
- Published:
- 07/01/2014
- Number of Pages:
- 16
- File Size:
- 1 file , 1.1 MB