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  • mjf34 replied to the topic Process Revalidation in the forum Process Validation and Process Risk 8 years, 1 month ago

    I have actually run into this at a previous job. We had a similar situation where we would move a piece of equipment from a production area to an R&D area. When needed for production, it would be used there and when it was not in use or scheduled for use, it would be used in the R&D area. This was done for two reasons: to save money (equipment cost) and to allow for development to occur on the same machine as production, in attempt to ease the scale up process. Unfortunately, since the machine was moved from one area to another and parameters were changed and parts were tampered with, the quality team often requires a process validation to ensure that the process and machine are still functioning correctly.