Monday, August 26, 2013

What is CAPA Corrective and preventive action

What is meant by CAPA (Corrective and preventive action) in Pharmaceutical manufacturing: 

In pharmaceutical manufacturing industry a facility involved in pharmaceutical manufacturing is required to meet laws laid down by FDA, one of important regulation for controlling quality of drugs being manufactured in good manufacturing practices guidelines listed in 21 CFR part 210, these guidelines mention that there should be a system laid down for reducing and eliminating noncompliance’s and deviations, by adapting systematic and scientific methodology. A part of quality assurance system is designed to find root cause of a noncompliance, or deviation, and a preventive action is designed and followed so that the noncompliance of similar nature does not occur again. To monitor the same a team of experts in Quality assurance and production, and regulatory, is formed and which analyze See here Guide For Pharma Regulatory affairs  Manufacturing Industry  

 1) Noncompliance's and their origin, root cause. Should clearly identify the origin, and root of noncompliance with data, and it should be able to establish in a reproducible manner if challenged.

2) Nature, its impact on product quality: The non-conformance or deviation should be analyzed for its impact on quality of product, the level at which its impact is there.

3) Design a corrective action: A scientifically formed system to eliminate the non-conformance, which is agreed by QA and Manufacturing team, and management.

 4) Design Preventive action: once non-conformance is observed , a systematic and scientifically designed preventive action is adapted at decided interval in the pharma manufacturing process, for example , a preventive maintenance of HVAC system which gives non-conformance with respect to quality of air being circulated in the manufacturing aria after a specified period, one can design a period period to such experienced and learned period for preventive maintenance

 5) Design a SOP for monitoring implementation of CAPA. To make sure that CAPA designed is able to take care of noncompliance which prevents its occurrence not occur again. For evaluation of effectiveness of CAPA is done by systematic evaluation of CAPA. (Corrective and preventive action) is one of regulatory requirement and it is subject to inspection by FDA as and when asked, hence its integral part of quality management system in a pharma facility. Non-conformance or non compliance's are required to be checked , in order to find them a routine system of internal audit or interdepartmental audits must be carried out.

1 comment:

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