How should records be retained under GMP?

• A. Records must be kept forever.
• B. Retention period as defined by policy/regulatory requirements; components include authenticity and accessibility.
• C. Records can be discarded after one year.
• D. Records are only stored offsite.

Answer: (B)

Records must be kept for a retention period defined by policy and regulatory requirements, and they must be authentic and accessible for review. This ensures you can verify quality history during audits, investigations, or recalls, and that the data hasn’t been altered while remaining readily retrievable. The exact duration depends on the product, process, and jurisdiction, so the policy sets the timeframe you must follow. Keeping records indefinitely isn’t necessary or practical, and discarding after a short period can miss important history. Simply storing records offsite doesn’t address how long they must be kept or how easily they can be retrieved. The key is a defined retention period plus controls that guarantee authenticity and easy access.