Deviation in Pharmaceutical Industry

Definition:
Deviation is defined as departure or from written down instruction or predetermined specifications or procedure during operation and performing any activity.

Deviation can be classified as (Types of deviation):
Planned deviation
Unplanned deviation 

Based on impact of the quality deviation can also categorized as
Minor deviation
Major Deviation
Critical Deviation 

Now a days concept of  planned deviation has been removed from many industry. The concept planned deviation is adopted as Temporary change control 

In planned deviation we deviate the parameter intentionally for short period of time. and it must have approval before the execution hence it can be consider as temporary change control


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