CAPA, short for Corrective and Preventive Action, stands for correction and prevention measures in the pharmaceutical industry and is a key element in quality management systems. CAPA serves to identify and correct problems that may affect the quality and safety of drugs (German translation: Arzneimittel) and to prevent them from reoccurring.

CAPA encompasses the following main aspects:

• Identifying the problem: Identification of defects in processes or products that can lead to deviations (translation into German: Abweichungen) from defined quality standards.
• Investigating the cause: Analyzing the causes of the problem. This can include the investigation of processes, devices, materials, systems or human factors.
• Developing and implementing corrective measures: Taking measures to correct identified problems and prevent them from reoccurring in the future. This can include changes to processes, equipment, procedures or employee training.
• Development and implementation of preventive measures: Recognizing and implementing measures to prevent potential problems before they even occur.
• Monitoring and revision: Continuous monitoring (German: Überwachung) of the effectiveness of the measures taken and, if necessary, their revision in order to ensure continuous quality improvement.

CAPA is an important part of pharmaceutical quality systems as it helps to eliminate the causes of problems and not just the effects, thus ensuring a higher standard of product safety and quality. CAPA is also a requirement of the GMP guidelines and of regulatory authorities such as the US FDA (Food and Drug Administration) and the EMA (European Medicines Agency).

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