Deviations in Protocols

Dear Forum collegues,

I have performed Cleaning validation execution for Bioprocess. In the process user used 30 equipments which are all critical to clean. Bracketing also done. Due to operator mistake, rinse and swab samples missed for 3 equipments which are crucial in Bio-process. any way it is a deviation from the protocol. is it necessary raise deviation for this or it can be addressed in protocol itself.

Please suggest…

Thanks in advance


Oh yes, this is definately a deviation from the protocol.

From you description, the protocol states that all equipment must be tested and, due to operator error, 3 critical items were missed. That is a deviation from the protocol. Deviations must be raised for this, so that the problem can be resolved (by repeating the relevant sections of the protocol?).

A note must be made in the relevant section of the protocol that “deviation XX was raised due to swabs and rinse water tests being missed on equipment zzzz, aaa & bbbb due to operator error” … or words to that effect. If you do not record that the swabs were missed AND a deviation was raised because of this, this would be a serious GMP non-compliance.

I hope this answers your question. Remember, any test stated in the protocol, which has not been done exactly as stated in the protocol will need to have a deviation raised for it.

Good response. Also, do not forget to have the Deviation approved by the proper signatories of your organization and then proceed with the re-qualification of that particular section that was missed. Make sure that you have properly trained operators that will help execute parts of the protocol - re-train if necessary.