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thuytienlecao replied to the topic Process Revalidation in the forum Process Validation and Process Risk 7 years, 1 month ago
Hi, I agree with most of you about the fact that the device needs to be validated again once it’s moved because you don’t know what could have changed during the process.But depends on the condition, you may not need to do the full validation from scratch. I want to add an FDA reference to this (posted in the other thread as well about re-validation).
Quote from FDA
“The extent of revalidation will depend upon the nature of the changes and how they impact upon different aspects of production that had previously been validated. It may not be necessary to revalidate a process from scratch merely because a given circumstance has changed. However, it is important to carefully assess the nature of the change to determine potential ripple effects and what needs to be considered as part of revalidation”