21 CFR 610.13 - General Safety, Purity and Potency - Constitution and Testing

What it says

Biological products must be free of extraneous material except when unavoidable, and must be tested for safety in a manner appropriate to the product before release, in addition to product-specific potency and purity testing required elsewhere in the biologics regulations.

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

What it means in practice

• This general safety testing requirement sits alongside product-specific potency requirements, meaning a biological product manufacturer typically has to satisfy both a general safety standard and a tailored potency assay before release.
• Extraneous material findings, particulates, foreign substances or contamination observed during visual inspection or testing must be evaluated against this general safety standard, not dismissed as cosmetic.
• Because biological products are inherently variable, this provision is part of why biologics manufacturing places heavy emphasis on in-process and lot-release testing rather than relying solely on final product specification.

What FDA inspectors look for

• Whether general safety testing was actually performed and documented for each lot prior to release, not just the product-specific potency assay.
• Whether visual inspection for extraneous material is built into the release testing program and whether failures are investigated.
• Whether the test methods used to demonstrate safety and potency are validated for the specific product and are not simply borrowed from a similar product without justification.

Related regulations