The General Chapter has now been published in Step 4 as well. The ICH Guideline Q4B , "Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions" describes the fundamental procedures regarding the test methods. For the individual methods, the results of the Expert Working Group are summarised in the corresponding annexes. Now the proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
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: To what extent can point 4 "Considerations for Implementation" lead to restrictions, since the FDA here reserves the possibility that it is the manufacturer's responsibilty to prove the suitability of the chosen method for a respective product. Otherwise the manufacturer is referred again to the meaning of the perspective of the individual regions.
More information on Annex 8 can be found here.
Developments in Sterility testing is one of the topics at the "Rapid Microbiological Methods Conference 2009", in Vienna, Austria, on 8 and 9 December 2009.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)