CAPA (Corrective and Preventive Action)

Definition of the term (“What is CAPA?”)

CAPA (Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tion) is a mea­su­re wi­t­hin the qua­li­ty ma­nage­ment sys­tem (QMS) and is part of GMP com­pli­ant ope­ra­ti­ons. This ana­ly­zes ac­tu­al faults or de­via­ti­ons in a struc­tu­red man­ner (cor­rec­ti­ve ac­tion) or im­ple­ments pre­ven­ti­ve ac­tions.

Com­pa­red to other QMS norms such as ISO 9001, CAPA is not di­rect­ly de­si­gned as a con­ti­nuous im­pro­ve­ment pro­cess lea­ding to con­stant­ly in­cre­a­sing pro­duct qua­li­ty. In­s­tead, the em­pha­sis is put on eli­mi­na­ting any de­via­ti­ons from re­qui­re­ments ba­sed on the ap­p­li­ca­ble le­gal re­gu­la­ti­ons and tech­ni­cal stan­dards for drug and me­di­cal de­vice safety.

The term CAPA ori­gi­na­tes from the me­di­cal de­vice re­gu­la­ti­ons and was also de­scri­bed in the ori­gi­nal sys­tem ele­ments in ISO 9001, ISO 13485 and FDA 21.

CAPA was first in­tro­du­ced in 2006 via the “Qua­li­ty Sys­tem Gui­d­ance” of the FDA. Sin­ce 2008 it is an ele­ment of a QMS ba­sed on the ICH gui­de­li­ne Q10 Phar­maceu­ti­cal Qua­li­ty Sys­tems. In the fur­ther pro­cess, the gui­de­li­ne was adop­ted in the new­ly ad­ded 3rd part of the EU GMP gui­de­li­ne.

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