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  • Fady Khalla started the topic Validation Expiration in the forum Process Validation and Process Risk 8 years, 7 months ago

    Hello Everyone,

    As I am learning more and more about validation (IQ, OQ, and PQ) I came across a question that may be of interest to many of you. We all know that once any changes occurs to the equipment, a revalidation may be deemed necessary or at least a justification from quality is needed to justify why revalidation is not necessary. The question I came across is what if no changes occurred to the equipment since validation, and the equipment have been operational and maintained per calibration and maintenance schedule. When will the original validation expire? Is there any regulatory requirement to revalidate the equipment after a certain period of time (e.g. 10 years or 20 years)?