In the context of the ICH activities, the ICH Topic Q4B Annex 8, Sterility Test, General Chapter in Step 3 has now been published as well. In the ICH Guideline Q4B , "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" the fundamental procedures regarding the test methods are described. For the individual methods, the results of the Expert Working Group are summarised in the corresponding annexes.
Annex 8 shows the results of the ICH Q4B Expert Working Group on the chapters Ph.Eur. 2.6.1. Sterility, JP 4.06 Sterility Test, and USP <71> Sterility Tests, which defines the three texts as interchangeable. This is a further step to reduce the necessary effort for the manufacturer of medicinal products within the framework of the registration procedure.
Like in the case of the already published annexes on the ICH Topic Q4B (compare GMP News from 26 November 2008), here, too, the question remains: In how far can point 4 "Considerations for Implementation" lead to restrictions, since the FDA here reserves the possibility that the manufacturer must give proof of the suitability of the chosen method for a respective product or is referred again to the meaning of the perspective of the individual regions.
More information on Annex 8 can be found here.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)