FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus

The FIP's (Fédération Pharmaceutique Internationale) "Dissolution/Drug Release Special Interest Group" (SIG) published a position paper on qualification of paddle and basket dissolution apparatus last year.

With this position paper, the working group (SIG) wanted to submit an internationally harmonised proposal based on all of last year's requirements concerning this matter (USP, Ph.Eur., JP, ICH 4B Annex 7, FDA Draft Guidance "Mechanical Calibration" as well as the ASTM Standard E2503-07).

The FIP position paper concludes that the FIP Dissolution/Drug Release SIG recommends performance of the qualification of a dissolution apparatus following the calibration requirements as indicated in the FDA (draft) guidance.

In the meantime, the FDA has indeed published the final Guidance for Industry on mechanical calibration, but since the actual FDA procedure on mechanical qualification remained unvaried, FIP's recommendation will surely still remain valid.

Furthermore, the FIP group notes in the abstract that further performance verification tests using the USP Reference Standard tablets can be conducted if additional information is desired by a company. But any strict requirement on the use of a specific performance verification test tablet is not recommended at this time.

For further information please refer to the complete FIP position paper.

Dr. Günter Brendelberger
OPn behalf of the European Compliance Academy (ECA)

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