Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System. This is supported by an FDA Guidance Document: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and ICH Q10; the Pharmaceutical Quality System. It is clear from FDA Form 483, Report of Observations given to pharmaceutical manufacturers and Warning Letters that the FDA is interpreting the GMPs (21CFR211) consistent with concepts found in ICH Q10; The Pharmaceutical Quality System. In this audio seminar we will discuss the systems that a firm must implement to be compliant with the CGMPs which is actually an implementation of the Pharmaceutical Quality System.