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Acceptance Criteria

The acceptance criteria are pre-defined and agreed standards, limits or ranges between different parties such as Quality Assurance and Quality Control or Manufacturing and Quality Assurance or suppliers

or

The specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan that are necessary for making a decision to accept or reject a lot or batch of raw material, intermediate, packaging material, or active pharmaceutical ingredient. This term can also be applied to validation.