21 CFR 820.75 - Process Validation (QMSR)

What it says

Where the results of a process cannot be fully verified by subsequent inspection and test, the process must be validated with a high degree of assurance and approved according to established procedures, with monitoring and control methods and dates and signatures of approving individuals documented.

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

What it means in practice

• This provision specifically targets processes where outcome cannot be fully confirmed by inspecting or testing the finished output, meaning validation is the primary evidence of process reliability rather than a supplement to finished-item testing.
• Process monitoring and control parameters identified during validation must continue to be applied during routine production, not just during the validation exercise itself.
• Revalidation is expected whenever process changes, equipment changes or other factors could affect the validated process, similar in principle to drug process validation expectations.

What FDA inspectors look for

• Whether processes correctly identified as requiring validation, because their output cannot be fully verified by subsequent testing, actually have documented validation on file.
• Whether process monitoring and control parameters established during validation are genuinely maintained during routine production, not just documented once at validation and then left unmonitored.
• Whether changes to a validated process trigger a documented revalidation assessment.

Related regulations