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Identifying the root cause for market complaints, out of specifications (OOS), deviations can be challenging, but a number of tools can help to investigate the root cause so that corrective and preventive actions can be effectively implemented.

FDA’s Quality System Regulation as well as the new guidelines on “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations” requires effective corrective and preventive actions (CAPA) with root cause analysis (RCA) as reactive tool for system improvement to ensure that significant problems do not re-occur. Unsatisfactory procedures for root cause analyses are amongst the most frequently found deviations in FDA warning letters.

The article below by James J. Rooney and Lee N. Vanden Heuvel depicts an efficient way to map an RCA structure leading to an effective CAPA.

root cause analysis

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