Offer extended until 31 July 2026: get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
New: ICH Q4B - Annex 13 on the Density of Powders
Recommendation
17/18 November 2026
Heidelberg, Germany
Enhanced Approach using AQbD Principles
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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.
Related GMP News
02.11.2026FDA Warning Letter: When Test Procedures Allow Retesting Until an Acceptable Result is Obtained
21.10.2026EMA Updates Information Page on Bioequivalence Guidelines
21.10.2026BP Publishes new Draft Texts
21.10.2026FDA Identifies Critical Deficiencies in Analytical Testing and CGMP Oversight
07.10.2026Analytical Quality Group Developments May through August 2026
07.10.2026Two New FDA Warning Letters Put OOS Investigations in Focus