Annexes to ICH Q4B Guideline Reach Next Step

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:

• Annex 7: Dissolution Test: http://www.gmp-compliance.org/guidemgr/files/MEDIA5778.PDF
• Annex 9: Tablet Friability: http://www.gmp-compliance.org/guidemgr/files/MEDIA5779.PDF
• Annex 10: Polyacrylamide Gel Electrophoresis: http://www.gmp-compliance.org/guidemgr/files/MEDIA5780.PDF

And two guidelines reached Step 2:

• Annex 11: Capillary Electrophoresis: http://www.gmp-compliance.org/guidemgr/files/MEDIA5781.PDF
• Annex 12: Analytical Sieving: http://www.gmp-compliance.org/guidemgr/files/MEDIA5782.PDF

With regard to the guidelines on capillary electrophoresis, the following descriptions of the analytical methods are considered as interchangeable:

• Ph.Eur. 2.2.47 Capillary Electrophoresis
• JP General Information 4. Capillary Electrophoresis
• USP General Information Chapter <1053> Biotechnology-derived Articles - Capillary Electrophoresis

And in the new Annex 12 on analytical sieving, the following pharmacopoeial methods are mentioned:

• USP General Chapter <786> Particle Size Distribution Estimation by Analytical Sieving
• Ph.Eur. 2.9.38 Particle-size Distribution Estimation by Analytical Sieving
• JP 3.04 Particle Size Determination entitled Method 2. Analytical Sieving Method

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".

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