FDA publishes ICH Q4B – Annex 13 on Density of Powders
The ICH Guideline on Density of Powders has now been published by the FDA and has thus come into force in the USA. Read more in the News about the possible restrictions of the FDA.
On 28 May 2013, the FDA also finally published the ICH harmonised Guideline entitled “Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders – General Chapter (Q4B Annex 13)”.
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 pharmacopoeias shouldn’t be performed separately when it has been assessed…
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