Difference between incidence and deviation

It causes a big confusion to understanding 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.

Deviation or deviate: a planned event required due to an unforeseen issue that is meant to keep control of the process/product but which does not follow standard operating practices/procedures.

When we have any written procedure like standard operating procedure, protocol, standard test procedure, BMR, etc. and someone works against this, then it is called deviation. It means deviation from any written procedure that we have implemented.

The deviation can be of two different types.

(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.

Unplanned deviations - 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

Critical deviation means a departure from an approved instruction or established standard that will affect the safety, identity, strength, purity and/or quality of a product. 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

The raw material is received in a damaged container, manometer readings in the sampling booth are crossed the action limits, etc.

Incident or incidence: an unplanned event that exceeds limits, specifications or expectations.

An incidence is an 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 the granulation area. these may have an 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.