16-18 November 2021
With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed.
The ICH strives to harmonise GMP and pharmacopeial requirements in its major regions of the EU, the U.S. and Japan. Based on the evaluation by the Q4B Expert Working Group (EWG), the ICH Steering Committee has recommended that the official pharmacopoeial texts, Ph.Eur. 20919, JP 6.07 and USP <788> for the test for subvisible particles can be regarded as comparable, provided that instrument calibration and their SST follow regional GMP requirements. This is not valid for the test of 100-milliliter (mL) parenteral products, because the acceptance criteria of the Japanese Pharmacopoeia are stricter than those of the two others. As always with ICH harmonisation processes, there is an addition stating that the FDA may request a demonstration that the chosen method is acceptable and suitable for a specific material or product, irrespective of its origin. For the EU, the harmonisation signifies among others that an application for approval may contain references to the Japanese Pharmacopoeia e.g. and that this will not lead to difficulties in the approval procedure. Variation applications for method changes (within the cited texts) should also be possible without problems.