Related to CAPA Requirements - Did You Know?

That under key FDA regulations, requirements pertaining to nonconformance disposition are directly related to CAPA requirements?


Under the Quality System Regulation (21 CFR Part 820.100), medical device manufacturers are required to establish a CAPA procedure that will investigate the cause of any product nonconformance and identify action that will prevent the recurrence of such nonconformance.

The CGMP regulations for finished pharmaceuticals similarly require that any failure of a batch, or any of its components, to meet specifications must be thoroughly investigated and documented, and that the documentation must include the investigation’s follow-up and conclusion (21 CFR Part 211.192).

Read more about the importance of effective nonconformance disposition: