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