CGA M-11

Compliance with the Quality Systems Approach to Pharmaceutical CGMPs Guidance, Second Edition

Compressed Gas Association , 07/01/2014

Publisher: CGA

File Format: PDF

$111.00$223.58

Description

Standard By:Compressed Gas Association , 07/01/2014

Published:07/01/2014

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.