Regulatory Focus™ > News Articles > FDA Announces Adoption of ICH Guideline on Pharmaceutical Powders

FDA Announces Adoption of ICH Guideline on Pharmaceutical Powders

Posted 24 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has released a new guidance document bringing the agency into alignment with the International Conference on Harmonisation's (ICH) standard on the approval of pharmacopoeial texts governing the bulk density and tapped density of pharmaceutical powders.


The ICH is a regional harmonization group composed of the US, EU and Japan, with other countries, such as Canada, participating in a voluntary capacity. The aim of the group is to allow the regulatory processes of each to better align with those of the others, thereby allowing greater efficiencies for industry. This is perhaps best exemplified by the common technical document, which permits a company to submit a pharmaceutical dossier to all three countries with only minimal changes to a single module of the submission format to account for minor regional differences.

That standardization process, however, goes far beyond just submission formats, extending as well to certain supporting texts, such as the regional pharmacopoeias of the ICH regions.

Three Texts Acceptable in Four Regions

Which is where the new guidance comes in.

The document, the 13th Annex of the ICH's Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions document, Bulk Density and Tapped Density of Powders: General Chapter, was released by FDA on 24 May 2013.

In it, FDA explains that the document is intended to facilitate the recognition of "selected pharmacopoeial texts" by ICH regulators such that they become interchangeable throughout the ICH regions.

"Implementation of the Q4B annexes is intended to avoid redundant testing by industry," FDA adds. Curiously, the ICH guideline calls not for the acceptance of a specific criteria, but rather permits the interchangeable use of three texts currently specified within each ICH region:

  • Ph. Eur. 2.9.34. Bulk Density and Tapped Density of Powders,
  • JP 3.01 Determination of Bulk and Tapped Densities
  • USP General Chapter <616> Bulk Density and Tapped Density of Powders

There are, however, some exceptions. The guidance explains that 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."  This contrasts with the stance of the EU, Japan and Canada, whose regulators will automatically accept those texts, according to the guidance.

FDA: Density of Powders Chapter

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