An Auditors Perspective: Maximising CAPA outcomes

Maximising CAPA outcomes: ensuring effective root-cause analysis in deviation inspections

Damiano Papini, M.Sc. Chemistry & MBA, Rephine Consultant & Auditor

The ability to identify, classify and manage deviations is key to an effective quality system for any pharma manufacturer. This includes the ability to pinpoint root causes of undesired events, enabling meaningful CAPA (Corrective/Preventive) activity that reliably reduces the risk of issues reoccurring.

All of this requires that a thorough and well-structured investigation has been carried out. Otherwise the reasons for any deviation may be misidentified, and the ensuing CAPA will miss the mark.

While a corrective action works on the immediate event, a preventive action focuses on the cause – looking to ensure that similar problems are avoided in future, even via other systems or processes.

The ICH Q7 GMP guide for Active Pharmaceutical Ingredients (API) prescribes that any critical deviation should always be investigated, and appropriate CAPA identified. A deviation is defined as a “departure from an approved instruction or established standard”. A critical deviation, meanwhile, is a “departure from established critical parameters, or a significant departure from standard operations which may affect the quality of the API or intermediate” – ultimately with a risk that the product is hazardous to patient health.

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