Dissolution Test - New ICH-/EMEA-Document

For several years now, the Pharmacopoeial Discussion Group and the ICH Q4B Working Group have been dealing with the harmonisation of the requirements laid down in the pharmacopoeias. In the meantime a number of ICH Topic Q4B Annexes have in fact been published.

In December 2008, the EMEA published the document "ICH Topic Q4B Annex 7 Dissolution Test - General Chapter" (Step 3). Comments on this document can be submitted until March 2009.

Generally it is recommended that the three official texts

  • Ph.Eur. 2.9.3. Dissolution 
  • JP 6.10 Dissolution Test 
  • USP <711> Dissolution

be considered as interchangeable - however, only under nine conditions, some of which represent restrictions. Examples of these restrictions are:

  • Enzymes must not be used in the medium
  • An equipment qualification in compliance with the regional GMP requirements must be on hand
  • Interchangeability can only be applied to Apparatus 1 and 2
  • Interchangeability does not apply to big containers (> 1 litre)

What is interesting is that point 4 again emphasises expressly from an FDA perspective that an "appropriately rigorous mechanical calibration method" as described on the FDA website fulfils FDA's CGMP requirements on dissolution apparatus calibration (see GMP News from 23 April 2008).

The complete EMEA draft document can be found here.

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

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