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Pharmaceuticals/Failing Cleaning Validations

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Question
Mr. Anisfeld,

During a recent cleaning validation on a non-OTC product filling system, the swab data revealed micro hits.  When a CV fails and a new cleaning procedure is introduced, does a new/revised validation protocol need created and approved?  The CIP/SIP cycle time in the protocol changed from 7 days to 4 days as a result of the failure.

Thanks

Answer
Steve:

Interesting question.

Your cleaning protocol should not include the specific details of the cleaning methodology. Rather, the cleaning validation protocol should be worded as follows:

"This cleaning validation protocol is to demonstrate that SOP 1234-version 3 titled "Cleaning of XYZ" cleans equipment to meet the Quality Acceptance Criteria stated in this protocol".

If you word it as above then the same protocol can be used again and again.

As you have failed your first cleaning validation, obviously the SOP you followed in its original version does not work. Perform an investigation as to why the failure, change the SOP (under change control), test the SOP again to make sure it works, prior to repeating the cleaning validation; and then when you know the revised version works, embark on your cleaning validation.

Good Luck.

Pharmaceuticals

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Michael Anisfeld

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