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julienneviuya replied to the topic Process Revalidation in the forum Process Validation and Process Risk 7 years, 1 month ago
I have come across this issue with a certain gauge that was applicable to several parts of the production process. The manufacturing department argued that it can just be specified that this gauge has several locations but still performs the same process. However, the production manager said that with each time it moves it should be treated like a separate gauge entirely and be qualified for each of those locations. After much deliberation, it was decided that if it can be qualified to be performing the same exact process no matter where it is placed and produce the same exact result, it would not need to undergo individual IQ/OQ/PQ for every individual location.