ICH Q4B - Annex 7(R2) on "Dissolution Testing" becomes binding in the USA too

In June 2011, the FDA published the Guidance for Industry "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - Annex 7(R2) - Dissolution Test General Chapter".

Through its ICH Q4B activities, the Q4B Working Group aims to facilitate - for chosen pharmacopoeial texts - mutual recognition by regulatory authorities in the three ICH regions. Through this, redundant investigations by the pharmaceutical industry should be avoided, too.

The current Annex already presents the second revision of this document. This second revision of Q4B Annex 7 contains specifications about additional apparatuses for Dissolution Testing to which Interchangeability applies in the ICH regions: the Basket Apparatus (Apparatus 1), the Paddle Apparatus (Apparatus 2) and the Flow-Through Cell.

There also have been updates of the considerations for implementation for the FDA, the European Union and the competent authority Japan (MHLW).

One of the FDA's specific remark concerns the fact that the mechanical calibration of apparatuses for Dissolution Testing which had been proposed in the past by the FDA is sufficient to comply with the CGMP requirements concerning calibration of dissolution apparatuses. The Document on mechanical calibration can be found


Please also see the complete

ICH Q4B - Annex 7(R2) for further information.

The ECA Education Course "Dissolution Testing" in Berlin, Germany, from 2-4 November 2011 will give an excellent overview of the current pharmacopoeial requirements. The highlight of the programme

will be the visit of the dissolution robots in the Bayer HealthCare Pharmaceuticals Laboratories in Berlin.

Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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