Q and A: CDER official offers tips on GMP inspections

Validation of manufacturing processes, handling of deviations, and laboratory operations are the top three areas that FDA investigators scrutinize during GMP inspections, according to a senior regulatory operations officer with the Center for Drug Evaluation and Research (CDER).

In this question-and-answer article, MasterControl Inc. interviewed a CDER official who discussed:

• Most common reasons why pharmaceutical companies receive a Form FDA-483;
• Things that investigators look for in terms of training and training control;
• What investigators look for when evaluating a CAPA system;
• What companies should do to prepare for a GMP inspection;
• What companies should do when they receive a Form FDA-483; and;
• Top three areas that FDA investigators are trained to focus on during GMP inspections.

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