CAPA: An important concept of Quality Assurance in Pharmaceutical Industry

CAPA is used in the improvements to be made in product, process or quality system to eliminate non-conformities and other undesirable situation. CAPA could be regulatory concept that focuses on systematic investigations to search out the root cause, understanding and correcting discrepancies while attempting to avoid their reoccurrence. Instructions for a way they must be handled within the organization just in case of potential product problems, customer complaints or action to eliminate the cause of a detected nonconformities or incident. Regulatory inspections give more importance for CAPA, for the explanation, it will high light the systems followed within the company additionally because the technical capability of the people concerned. Changes proposed are to be verified and validated to confirm the effectiveness and quality attribution. CAPA is also an integrated part of ISO: 13485 and Good Manufacturing Practice (GMP) for medical products. The FDA defines the purpose of a CAPA procedure as: collecting and analyzing information, identifying and investigating product and quality problems, and taking appropriate and effective corrective and/or preventive action to prevent their recurrence. There is not a regulatory defined framework for the CAPA process only different requirements. The CAPA system investigation document will provide a clear picture of how the standard system works and hence, Regulatory Inspectors give lot of importance to audit this method. Real root cause is to be identified with scientific proof and which further may not be generated. This review provides comprehensive views on steps involved in corrective action and preventive action (CAPA), mechanism of taking CAPA enabling to boost the system of quality management. CAPA is a component of the overall quality management system. As per the FDA documents CAPA accounts for 30-50% of FDA-483 forms issued for noncompliance.