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CAPA definition

Corrective & Preventive Action (CAPA) procedures are designed to regulate (potential) nonconformities for the pharmaceutical industry;

To make drug production conform to regulations and industry standards;

At the same time, reduce the defect rate and the probability of deviation, so as to realize the continuous improvement of quality assurance system.

Scope of application of CAPA

It is suitable for the formulation, implementation and closed-loop confirmation of all kinds of (potential) non-conformance CAPA generated in the operation process of pharmaceutical GMP. In production quality activities, if emergency measures can be taken immediately to solve problems and there is no impact on the quality of related product batches, this procedure can not be implemented, except for the second time or more, it should be reflected in the BPR and other relevant records.

CAPA definition

Scope of application of CAPA

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400-0569-812