21 CFR 211.165 - Testing and Release for Distribution

What it says

Each batch must be tested against its release specifications before distribution, appropriate laboratory determination of conformance must be made, and for products where sterility or pyrogen testing is required, no batch may be released until such testing shows satisfactory results, with the accuracy, sensitivity, specificity and reproducibility of test methods established and documented.

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

What it means in practice

• Every applicable specification must have a documented, valid result before release - a batch cannot be released based on partial testing with the remainder assumed to be acceptable.
• Test results supporting release must come from validated methods run by analysts whose training was current at the time of testing, not simply methods that were validated at some point in the past.
• For sterile or pyrogen-tested products, this is an absolute precondition to release, not one factor weighed among others in a holistic release decision.

What FDA inspectors look for

• Whether every specification parameter has a documented, individually reviewed result, rather than a summary pass or fail conclusion covering multiple tests.
• Whether analytical results supporting release came from analysts with current, valid training records for the specific method used.
• Whether any batch was released with an open investigation, out-of-specification result, or incomplete documentation.

Related regulations