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Question of the Week

How can a CAPA system be implemented in a pharmaceutical company?

Principally, a CAPA system can be implemented in a pharmaceutical company using two different approaches (see below). Regardless of the selected organizational structure, it should be ensured that the CAPA system is understood as an important element of the pharmaceutical quality system and consequently be implemented uniformly company-wide or group-wide, as a governing system.
Independent CAPA System: An independent CAPA system is characterised by its own documentation and schedule tracking. In an independent CAPA SOP, the procedures for the definition, responsibility, schedule tracking, and closing of CAPA activities are described.
Linked CAPA System: A more convenient way of establishing a CAPA system is to specify relevant CAPA procedures within the triggering system. In that case, the documentation form of the initial incidence (e.g. a deviation) would, following a risk assessment, document also the defined corrective actions as well as the implementation and the final efficacy check. After closing of both the initial incidence or problem and the specified CAPA activities, the responsible quality unit can easily evaluate and track both interlinked processes.

[GMP MANUAL, Chapter 19.D.4]

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