FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
|Event Date/Time: Mar 23, 2007||End Date/Time: Mar 23, 2007|
Quality should be built into a product, and testing alone cannot be relied on to ensure product quality. This overarching philosophy is articulated in both the CGMP regulations and in robust modern quality systems. This FDA guidance is not intended to place new expectations on manufacturers, nor to replace the CGMP requirements.
•QS Model’s consistency with the CGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products
•How QS Models allow manufacturers to support and sustain robust, modern quality systems that are consistent with the CGMP regulations as codified in 21 CFR parts 210 and 211
•How the inherent flexibility of the CGMP regulations enables manufacturers to implement a quality system in a form that is appropriate for their specific operations.