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 at least two years past the expiration date, depending on what your APIs are used for. If your products are used in clinical studies, I’d suggest you keep your records even longer.

Answered by Jan Olson, EduQuest VP of Regulatory and Quality Services (22 years as an FDA investigator and office director) and lead instructor for EduQuest’s Managing and Auditing Supplier Quality training class.

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