Differentiation between an incidence and deviation
when it occurs in pharmaceutical GMP manufacturing facility. It causes a big confusion to understand the occurrence of incidence and deviation in pharmaceuticals. A huge number of pharmaceutical professionals difficulties to differentiate the incidence and deviation when they occur in real.
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. Now deviation can be of two different types:
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 case of unplanned deviation, the failure of procedure, utility, material, equipment or any system is occurred. 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 categorised on their impact of 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 impact on product quality but not every time, sometime it will not impact. These are the deviations from GMP but 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 production area, spillage of material on floor, break down in any machine during processing, mix-up of two batches, wrong material added in batch etc.
when it occurs in pharmaceutical GMP manufacturing facility. It causes a big confusion to understand the occurrence of incidence and deviation in pharmaceuticals. A huge number of pharmaceutical professionals difficulties to differentiate the incidence and deviation when they occur in real.
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. Now deviation can be of two different types:
- Planned Deviation
- 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 case of unplanned deviation, the failure of procedure, utility, material, equipment or any system is occurred. 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 categorised on their impact of 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 impact on product quality but not every time, sometime it will not impact. These are the deviations from GMP but 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 production area, spillage of material on floor, break down in any machine during processing, mix-up of two batches, wrong material added in batch etc.
