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julienneviuya replied to the topic Maintenance & validation in the forum Process Validation and Process Risk 7 years, 1 month ago
I agree with the posts above, depending on the degree of failure and the complexity of the machine, it may need to undergo IQ OQ PQ again to ensure safety and efficacy. However, if it is just undergoing routine maintenance or is a minor discrepancy, there is no need to undergo these processes. It may just require a few start up runs before being placed in full production again.