Acceptance Criteria
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The predefined, documented, and quantifiable pass/fail limits against which the results of a qualification, validation, or test activity are judged, established and approved before execution begins so that success or failure is assessed objectively rather than after the results are already known.
Acceptance criteria are derived from the underlying requirement — a specification limit, a URS entry, or a risk assessment — and must be justified, not arbitrarily chosen. Setting them before execution is the entire point: if criteria could be adjusted after seeing the data, a passing result would prove nothing.
Results that fall outside acceptance criteria are not quietly reworked — they are handled as a deviation or protocol exception with formal investigation, and any change to the criteria themselves goes through the same documented approval the original criteria received.
- —Set and approved before test or study execution — never adjusted retrospectively to fit results
- —Derived from a specification, URS entry, or documented risk assessment
- —Distinct from action/alert limits used in ongoing routine monitoring
- —Out-of-criteria results are handled through deviation/investigation, not silently reworked
FDA Process Validation: General Principles and Practices (2011); EU GMP Annex 15; ASTM E2500-25
Frequently asked questions
What is Acceptance Criteria?
The predefined, documented, and quantifiable pass/fail limits against which the results of a qualification, validation, or test activity are judged, established and approved before execution begins so that success or failure is assessed objectively rather than after the results are already known.
Which regulations cover Acceptance Criteria?
FDA Process Validation: General Principles and Practices (2011); EU GMP Annex 15; ASTM E2500-25