21 CFR 610.12 - Sterility

What it says

Biological products must be tested for sterility, using the methods and sampling described in the regulation or in an approved application, with exceptions listed there. The test applies to each lot of a final product and to certain bulk and in-process materials. Where a product fails, it cannot be released.

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

What it means in practice

• Sterility testing is a final check, and it does not replace sterile manufacturing controls.
• The test method must be suitable for the product, with interference from the product itself addressed.
• A positive result needs a documented investigation before any retest decision.

What FDA inspectors look for

• Whether sterility tests are performed on each lot as required.
• Whether the method is validated for the product.
• Whether failures are investigated and documented.

Related regulations