Acceptance Criteria

The threshold that determines if a test passes or fails

Acceptance criteria is defined in ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients as "Numerical limits, ranged, or other suitable measures of acceptance of test results". The acceptance criteria is determined through appropriate means prior to conducting routine activities or validation of analytical methods and cleaning processes. Appropriate means may refer to consulting guidance's for specific acceptance criteria such as USP <1225> Validation of Compendial Methods for determining analytical method acceptance criteria or utilizing the methodology listed in PDA Technical Report 29, Points to Consider for Cleaning Validation to calculate acceptance criteria for cleaning processes.