Example of Deviation

Minor deviation:
-Written wrong batch number 

-Skip of FEFO principle (first expired-first in out) and FIFO(First in out) in raw material handling.

- Cleaning activity is not perform in ware house.

Major Deviation:

- Inadequately trained personnel to perform Analysis.

- Production started without line clearance activity

-Use of unapproved reference standard to test an API or drug product.

- Pressure differential out of established limits in aseptic fill areas.

Critical Deviations

- Temperature out of control in critical parameters 

- Expired or rejected API component used.

- Sterilization record of product-contact material used in aseptic filling process not     available or unacceptable.

for all type of deviation proper corrective action preventive action will be taken  after if required.