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A Review On Capa In The Pharmaceutical Industry
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| Author:
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V.S.THIRUVENGADARAJAN, I.PONNILAVARASAN, SURIYAPRIYA.K, ANUYASHIKA.T, PRAKASH.M, GOWTHAM.D
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| Abstract:
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Corrective actions and preventive actions (CAPAs) are a very important part of maintaining pharmaceutical quality systems and medical devices-producing industries. CAPA is a subsystem that harmonizes all quality subsystems, closing a quality loop. Once discovered that there are weaknesses, including failures in the production or testing of drugs, investigations into the cause(s) should commence. Corrective action and preventive action have been taken to correct product nonconformity, quality problems, and preventing problem recurrenceas a result of a risk analysis. A CAPA program is mainly for the improvement of product, process, and quality systems. The corrective and preventive action is designed by a team that includes quality assurance Head and personnel involved in the observation of actual point of non-conformance. It must be systematically implemented and observed to prevent future problem.This review gives an insight into the corrective and preventive actions as well as the series of actions involved in the CAPA plan.
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| Keyword:
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CAPA, Corrective action, Preventive action, Risk Management System.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.240
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| Download:
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