The keywords: quality assurance system, proper deviation reporting system, GMP requirements, personnel responsibilities.

Pharmaceutical companies are obligated to have a proper deviation reporting system to investigate all deviations and non-conformances. The system is one of most important components of the quality assurance system. The system is aimed to perform an investigation of all deviations in accordance with a written procedure. The goal of the investigation is to find the root cause of the deviation. The decision and conclusions about the quality of product are documented. Once the root cause has been determined, corrective and preventive actions (CAPA) can be implemented. Deviations that have an impact on the quality of drugs that are already available for sale should be reported on a Field Alert Report to the FDA (FDA Form 3331, 21 CFR Part 314.81 (b) (1)). A proper deviation reporting system allows QA to track and trend deviations. Trending should be done to ensure that deviations will not repeat themselves in the future. If a trend is noticed, an investigation should be extended to determinate whether more corrective actions are necessary. The deviations should never be “hidden”. Anyone who discovers a deviation must report it immediately.

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