Dissolution Testing in Human Drug CGMP Notes

GMP News No. 455

23 August 2004

DissolutionTesting in Human Drug CGMP Notes

The FDA received inquiries regarding dissolution testingfrom some FDA Investigators as well as from members of the pharmaceuticalindustry. What kinds of USP dissolution test failures are significantenough to be noted on Forms 483? Is a failure in dissolution testing atstage 1 level, for instance, significant enough to be cited on an FD-483?

Inthe Human Drug CGMP Notes of March 1995 and March 1996, the FDA clarifiedthis question to the satisfaction of the pharmaceutical industry:

"Routine failure of manufactured batches of aproduct to pass USP Dissolution tests at Stage 1 is not significant enoughto be noted on Forms FD-483; neither is occasional failure of individualdosage units at Stage 2. A batch does not fail the USP Dissolution Testuntil it fails at Stage 3. However, frequent failuresat Stage 2 are significant when other batches of the same producthave Stage 3 failures, and therefore should be noted on FormsFD-483."

The above paragraph is meant to summarise the most important statementson dissolution testing in the Human Drug CGMP Notes.

A very topical publication on dissolution testing dating from 2003,which has been created with FDA's co-operation, are the "FIP/AAPS Guidelines toDissolution/in Vitro Release Testing of Novel /Special Dosage Forms."You can download them by clicking here.

Dr Günter Brendelberger

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