Deviation and Incidence

Deviation and incidence in pharmaceuticals both the terms are differient with differient 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

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

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.