New: ICH Q4B - Annex 13 on the Density of Powders
Recommendation
7/8 October 2025
Performance Evaluation and Monitoring for compliant Analytical Procedures and Processes
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The ICH published the harmonised guideline "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) on 7 June 2012.
With the ICH Q4B activities, the relevant Q4B Working Group intends to reach a mutual recognition by the regulatory authorities in all three ICH regions for all test procedures listed in the ICH Q6A Guideline on specifications.
This means that comparable tests, required in the different pharmacopoeias must not be carried out separately if the authorities have decided that they are comparable and interchangeable.
Apart from the three ICH regions the Canadian authority has also confirmed that the methods described in all three pharmacopoeial texts can be considered interchangeable.
More information is available in the complete ICH Q4B - Annex 13.
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