FDA Documents, Statements Prioritize the ‘P’ in CAPA: Expert

An effective corrective and preventive action (CAPA) program will prioritize prevention and continuity in process improvement — primarily by linking to manufacturing systems beyond those concerned with deviation management and failure investigations, compliance experts say.

Quality personnel at drug companies often express confusion about how an effective CAPA program should be designed, citing the lack of a singular go-to guidance document or manual.

As a result, CAPA issues are routinely cited in warning letters year after year.

The quality of pharma products and good manufacturing practices (GMP) are in the s FDA’s crosshairs, and a top priority during inspections. Drug GMP Report has provided thorough analysis and interpretation of ever-changing GMP regulations, FDA enforcement trends and warning letters, international regulations and more. It’s akin to receiving a monthly executive briefing packed with the latest on inspection hot spots, developments in certification procedures, electronic data requirements and evolving trends in drug GMP enforcement.

It’s the fastest, most reliable way to make sure you're an industry expert, so get up to speed and subscribe to our daily publication today!