Tag Archive for Janis Olson

FDA Requirements for Source Data

Q: I’m trying to locate the source of the regulatory requirements to 1) maintain original source data as part of the official record and 2) maintain each copy of an executed qualification/validation protocol. Can you point me in the right direction?…

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Archiving Training Records

Q: Can you tell me how long I should keep training records and when to archive them? We manufacture active pharmaceutical ingredients (APIs) with an expiration date of five years. A: The rule of thumb is to keep training records…

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