DEVIATION AND INCIDENCE
Deviation and incidence in pharmaceuticals both the terms are different with different meanings most of pharmaceutical professionals are confused to differentiate between them when they occur. In the article we will differentiate between them with example and clarify the difference .
Deviation and incidence
DEVIATION
Deviation is defined as when we are deviating from written procedure or GMP(Good manufacturing practices) document. Deviation is further classified in two types
- Planned deviation It is defined as deviation which is preplanned and we know the outcome that it will not impact on product quality. Example We have validated the batch in 27 station cadmach press. Due to urgent batch requirement we have to run the batch on 27 station chamunda press. so, we can take a Planned deviation as we know it will not impact the quality of our product.
- Unplanned deviation It can be defined as deviation from written procedure Example SOP tells us to check the integrity of Finger bag before drying but it has not been checked and drying is started and during drying the finger bag is found damaged and powder escaped from bag it will be classified under Unplanned deviation as we have not followed the written procedure to check the Finger bag integrity prior to start of drying.
INCIDENCE
Deviation and incidence
Incidence is defined as something non cGMP(current Good manufacturing practices) have occurred all of sudden which may or may not have impact on product Quality. Example We have checked the Integrity of Finger bag before drying of batch in FBD(Fluidised bed dryer) but despite the Finger bag damaged somehow in FBD during drying. It will be classified under Incidence as we have followed SOP and still the accident occurred.
Every organisation must have Incidence reporting form .
Deviations are reported through Deviation form Unplanned deviations are further classified into Critical , Major and Minor Deviations.
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:
A﴿ Planned Deviation
B﴿ Unplanned Deviation
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 categorized on
their impact of product quality.
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.
the sampling booth are crossed the action limits, etc.
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.
floor, break down in any machine during processing, mix-up of two batches, wrong material
added in batch etc.
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