Respected sir, am totally confused unplanned deviation and incident
Please describe with examples…
1 Like
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- 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.
3 Likes