Deviation/incidence in pharmaceuticals

It causes a big confusion to understanding the occurrence of incidence and deviation in pharmaceuticals.

#Deviation terminology:
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.

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.

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 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, equipment breakdown during processing,Raw materials received in damaged cartons,etc

#Minor deviations:
—Errors in the documentation that do not affect data integrity
— Spillage of a product during the dispensing process,etc

#The incidence terminology:
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 damage in the facility . 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 manufacturing, the mix-up of two batches, wrong material added in batch etc.

The deviation management process flow has 5 main phases:

1.Identification
2.Reporting
3.Investigation
4.Documentation
5.Implementation

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