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Pharmaceuticals/Failing Cleaning Validations


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.



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.


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Michael Anisfeld


Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements


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