REGULATORY ASPECT OF CAPA IN QUALITY MANAGEMENT SYSTEM
ABOUT AUTHOR:
Devesh Sharma
M.Pharm-DRA
School of Pharmaceutical Sciences, JNU, Rajasthan
Trainee, Chemist, Ind-swift labs ltd, Mohali, (punjab)
devesh.m.pharmdra@gmail.com
ABSTRACT:
Corrective and Preventive Action (CAPA)is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence. To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions undertaken. CAPA is part of the overall quality management system.CAPA is of paramount importance to the FDA. According to FDA documents CAPA accounts for 30-50% of FDA-483 forms issued for non compliance.