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how can we decide the limit of cleaning validation? What is
the criteria for it?

Answers were Sorted based on User's Feedback



how can we decide the limit of cleaning validation? What is the criteria for it?..

Answer / ramana reddy

limit of cleaning validation shall be calculated by
considering worst case product based on the least
solublity, therapeutic dose and toxicity of the product.

The criteria for calculating the cleaning validation is of
both DOSE criteria and 10 PPM criteria.

Is This Answer Correct ?    19 Yes 3 No

how can we decide the limit of cleaning validation? What is the criteria for it?..

Answer / naveen

limit of cleaning validation shall be calculated by
considering worst case product based on the hardest to clean ,least
solublity, therapeutic dose and toxicity of the product.

The criteria for calculating the cleaning validation is of
both DOSE criteria and 10 PPM criteria

Is This Answer Correct ?    0 Yes 1 No

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