FDA publishes ICH Q4B – Annex 6 on Uniformity of Dosage Units

GMP News: FDA publishes ICH Q4B – Annex 6 on Uniformity of Dosage Units


On 16 June 2014, the FDA published the ICH harmonised Guideline entitled “Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter (Q4B Annex 6)”. This ICH Guideline thus came into force in the USA, too.

The objective of the ICH Q4B Working Group is to reach mutual recognition by regulatory authorities in the ICH regions for all testing methods listed in the ICH Q6A Guideline on Specifications. Through this, comparable testing laid down in the different pharmacopeias shouldn’t be performed separately when it has been assessed by the authorities that those are similar and interchangeable.

The Annex 6 states that the following official texts :

  • Ph.Eur. 2.9.40 (Uniformity of Dosage Units
  • JP 6.02 Uniformity of Dosage Units
  • USP General Chapter <905> Uniformity of Dosage Units

can be used as interchangeable. Nevertheless, certain restrictions listed under the section “Analytical Procedures” have to be considered.

To get more details please see the complete FDA “Q4B – Annex 6 Uniformity of Dosage Units General Chapter“.

PS: At the QbD/PAT Conference from the University of Heidelberg from 15-16 October 2014, Dr Øyvind Holte from the Norwegian Medicines Agency will present the uniformity of dosage units using large sample sizes (Ph.Eur. 2.9.47). Dr Øyvind Holte is a member of both the EDQM PAT working party and the EMA PAT team.


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