What is CAPA in pharma?

What is the definition of a CAPA in pharma?

CAPA is an abbreviation for Corrective Actions and Preventive Actions. The term, although used frequently in the pharmaceutical industry, does not originate from the pharmaceutical industry.

The terms “Corrective Action” and “Preventive Action” originate from ISO9001. It was introduced in the ISO9001 standards in 2005, as part of ISO’s guidance on quality management systems.

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The ISO9001 Quality management systems — Fundamentals and vocabulary defines the terms “corrective action” and “preventive action” as follows:

corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence.

preventive action: action to eliminate the cause of a potential nonconformity or other potential undesirable situation.

The purpose of the CAPA in the pharmaceutical industry is to prevent another nonconformity from occurring and to eliminate recurrence of any potential nonconformities.

Regulatory references to CAPA's

EU GMP & EU GDP (referring to ICH Q10)

U.S. FDA (dedicated article on CAPA's)

WHO TRS981 Annex 2 on QRM pg. 83

Why are CAPA's important in pharma?

One of the most important quality system elements is the corrective and preventive action subsystem.

But why?

The most important underlying principle is that we (in the pharmaceutical industry) need to learn from our mistakes and severely limit reoccurrence of the mistake / it’s consequences.

Completely eliminating mistakes is impossible, as long as humans are involved, mistakes will be made.

Without a formal system to investigate and analyze mistakes patient safety could be at risk.