21 CFR 600.12 - Records - Biological Products

What it says

Records relating to the manufacture of biological products must be maintained in a manner that allows accurate and ready identification of the manufacturing history of each lot, retained for a defined period, and made readily available to FDA for inspection and copying upon request.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The readily available standard means records must be organized and accessible in practice, not merely retained somewhere, since a biologics manufacturer that cannot promptly produce lot history records during an inspection can itself become a finding.
• Because biological products carry inherent lot-to-lot variability, complete and traceable manufacturing records are relied on more heavily than in many small-molecule contexts to reconstruct exactly what happened to a specific lot.
• Record retention periods for biologics are tied to product-specific factors such as expiration dating, so a manufacturer must track retention obligations per product rather than applying one blanket retention rule.

What FDA inspectors look for

• Whether requested lot manufacturing records can actually be retrieved and produced promptly during the inspection, not just confirmed to exist somewhere.
• Whether retained records are complete enough to reconstruct the full manufacturing history of a specific lot, including materials, in-process testing and deviations.
• Whether record retention periods applied match the specific requirements tied to that product's expiration dating and use.

Related regulations