Regulatory Focus™ > News Articles > ICH Releases New Interchangeability Standard for Pharmaceutical Powders

ICH Releases New Interchangeability Standard for Pharmaceutical Powders

Posted 11 July 2012 | By Alexander Gaffney, RAC 

The International Conference on Harmonisation (ICH) has announced the release of a new quality document pertaining to the bulk density and tapped density of powders, saying two existing pharmacopoeial texts may be interchangeable within the ICH regions.

The ICH is composed of three regions: the US, the EU and Japan. Two of the region's pharmacopoeias-the EU Pharmacopoeia and the US Pharmacopoeia-both have guidance documents available pertaining to the bulk density and tapped density of powders.

ICH noted both Ph.Eur. 2.9.34 and USP <616> are, for all intents and purposes, interchangeable. "However," said ICH, "FDA might request that a company demonstrate that the chosen method is acceptable and suitable for a specific material or product, irrespective of the origin of the method."

The annex is currently in Step 5 of the harmonization process, and is awaiting adoption by the host countries of the regions, which it notes may take some time to occur. In addition to the US, EU and Japan, the document will also apply to Health Canada.


Read more:

ICH - Bulk Density and Tapped Density of Powders General Chapter


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