FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations

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.

FEATURED TOPICS
•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.

2)PATRICIA MARONEY-BENASSI, PHD
ORA Quality Management System Program
Manager, Office of Enforcement
ORA, FDA.

3)JUNE LIANG, PHD
CMC Review Chemist
Division of Manufacturing Technologies
Office of New Animal Drug Evaluation
CVM, FDA.

4)DENNIS M. BENSLEY, JR., PHD
Acting Director, Division of Manufacturing
Technologies
Office of New Animal Drug Evaluation
CVM, FDA.