It causes a big confusion to understand the occurrence of incidence and deviation in pharmaceuticals. A huge number of pharmaceutical professionals get difficulties to differentiate the incidence and deviation when they occur in real.
A) Planned Deviation B) Unplanned Deviation
Planned deviations are those deviations from the procedure that are planned and we know before they occur. For example calibration or validation is not carried out as per schedule due to delay for various reasons. In this case, we have to fill CAPA for the same.
In the case of unplanned deviation, the failure of the procedure, utility, material, equipment or any system occurs. We can consider it as any change from the previous or our written procedure. Unplanned deviations may be critical, major or minor. These can be categorized on their impact on product quality.
Critical deviations: Manufacturing instructions are not followed, wrong batch details are printed, SOPs or methods of testing not followed during analysis etc.
Major deviations: Line clearance is not taken from QA, physician sample wrongly printed with price, etc.
Minor deviations: Raw material is received in a damaged container, manometer readings in the sampling booth are crossed the action limits etc.
Incidence is any event that can affect our product quality or not but that is against the cGMP. For example, someone is found without gowning in the production area or any insect is found in granulation area. These may have the impact on product quality but not every time, sometimes it will not impact. These are the deviations from GMP but the difference is that these are not related to our manufacturing process. So these will not be categorized as deviations.
Some other examples of incidence: eating food in the production area, spillage of material on the floor, break down in any machine during processing, the mix-up of two batches, wrong material added in batch etc.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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