What is a CAPA process?
CAPA is an abbreviation for "Corrective and Preventive Action". The CAPA process was first introduced in 2006 by the FDA (Food and Drug Administration) in the USA as part of the Quality Systems Guidance issued, which later formed the basis of the ICH Guideline Q10 relevant to the pharmaceutical sector. ICH Guideline Q10 has now also been included in Part 3 of the EU GMP guidelines, highlighting the implementation of the CAPA process in the pharmaceutical environment.
