Hygiene is essential in the pharma industry, but there are a surprising number of ways that cleaning – and its verification – can go wrong.
Andrei Blasko, Imad A Haidar Ahmad |
Many companies have been on the receiving end of FDA warning letters – and issues around cleaning arise time and time again. Failure to adequately clean equipment, failure to validate the cleaning verification method, failure to follow cleaning procedures... A quick reminder of the regulations: the cleanliness of non-dedicated equipment should be verified before subsequent release for use in the manufacture of intermediates and APIs, and at product change over to prevent cross-contamination. The cleaning procedure must be validated according to FDA requirements (1), and companies must employ cleaning steps that are reproducible and effective.
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