As the title itself suggest CAPA is an important function of quality management system in pharma industry. Good manufacturing practices guidelines laid down by US FDA clearly mention that, a pharma company must have a prompt system in its quality management system which is capable of proper handling and addressing market complaints, nonconformance of quality assurance system or manufacturing process or manufacturing facility, personnel’s machinery and ancillary systems which are part of manufacturing of a drug product, in a manner so that the discrepancy or nonconformance does not occur. For that purpose a prompt system of implementation of corrective and preventive actions, is required to be adapted, otherwise a drug may be deemed as substandard quality in event of failure to comply with the GMP guidelines.
There should be a prompt system for handling of complaint, or discrepancies or deviations observed.
The complaint may arise from, market, or end user or middle man stockiest, or the staff itself which is engaged in manufacturing or sale of drug product. Internal and external quality audits are tools in finding nonconformance in quality assurance system or manufacturing process or manufacturing facility, personnel’s machinery and ancillary systems which are part of manufacturing of a drug product.
Internal or external audits are meant for evaluation and inspection of functioning of the facility or an organization engaged in quality management of pharmaceutical or drug product. And outcome of such audits are Observations a Discrepancies. Nonconformances Deviations
All such nonconformances and market complaint are handled with a system of corrective and preventive actions in following steps.
1) Identify root of the cause, Root Cause Analysis:
A proper inspection or audit with respect to documents and events interviewing personnel’s or laboratory analysis is done in order to find out root cause of the complaint or discrepancy, scientific base should be adapted where ever applicable.
2) Identification and adaption of corrective action :
A proper methodology must be adapted to assign a corrective action for addressing a complaint or nonconformance so that it does not occur again, and the present problem is solved, a corrective action is also meant to resolve the observed nonconformance or complaint.
3) Developing and adaption of preventive action:
A scientific approach is adapted in designing or developing a preventive action, a method by which a nonconformance or discrepancy in product quality, manufacturing process or documentation, or quality system can be prevented.
4) Implementation of preventive action:
A system of preventive action is adapted by virtue of which a observed in discrepancy or the cause of discrepancy is avoid permanently. It is then made a part of quality assurance system, in process checking for implementation of preventive action. In many pharma company a team of key people is dedicated for implementation of corrective and preventive actions.