Limits and Acceptance Criteria

The most important element of a good cleaning validation program is the determination of limits and acceptance criteria. When determining the limits, care must be taken so that they are achievable by the analytical methods available for the specific product and active ingredient, are practical for the actual cleaning situation to be validated, and are scientifically rationalized and verifiable.

The most commonly used basis for setting the acceptance limit is a mathematical calculation that allows a certain therapeutic dose to carry over into each dosage unit of the next product. The actual numerical limits are based on the pharmacological potency of the product, the toxicity of the residue, and the analytical limit of detection.

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