Testing into compliance – who is doing it and why?

Testing into compliance is a USP/FDA requirement in the area of drug dissolution testing which is the only test available and recommended to indicate quality of the products in particular tablet/capsule.

The reason for the 3- (or 4-) stage testing into compliance (USP/FDA Tolerance) is because of regulatory requirement of using flawed (also non-validated/non-GMP) dissolution testers and methods which are known to provide irrelevant and unpredictable results. Scientifically speaking, there is no reason of using the currently recommended testers, in particular USP Basket/Paddle, for evaluating the products. Blame the USP/FDA for requiring this testing into compliance practice not the analysts and/or the companies.

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