During the meeting of the ICH Steering Committee in St. Louis, Missouri, in October 2009 five annexes to the ICH Q4B Guideline could be brought a step closer to their finalisation.
At the meeting, three guidelines reached Step 4:
And two guidelines reached Step 2:
With regard to the guidelines on capillary electrophoresis, the following descriptions of the analytical methods are considered as interchangeable:
And in the new Annex 12 on analytical sieving, the following pharmacopoeial methods are mentioned:
As an addition to this Annex 12, there is a detailed Appendix A with an excerpt form the Japanese Pharmacopoeia bearing the title "Draft JP XV Supplement II English Text Provided by MHLW / 3.04 Particle Size Determination".
Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)