Tag Archive
The following is a list of all entries tagged with Q4B:
Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex 8 Sterility Test General Chapter for ICH Regions
Filed in manufacturing, January 8, 2010, 8:35 amThis annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
Drug Regulators, FDA CDER, Publish Guidance on Q4B Annex5 Disintegration Test General Chapter for ICH regions
Filed in manufacturing, January 7, 2010, 8:31 amThis annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions.
Drug Regulators, FDA, Publish Q4B Evaluation and Recommendations for Pharmacopeial Texts for use in ICH regions, Annex 12: Analytical Sieving General Chapter
Filed in manufacturing, December 24, 2009, 10:41 amThe ICH Steering Committee, based on the evaluation by the Q4B Expert Working Group (EWG), recommends that the analytical procedures described in the official pharmacopoeial texts, Ph.Eur. 2.9.38. Particle-size Distribution Estimation by Analytical Sieving, JP 3.04
Drug Regulators, FDA, Publish Q4B Evaluation and Recomendations for Pharmacopeial Texts for use in ICH regions, Annex 11: Capillary Electrophoresis General Chapter
Filed in manufacturing, December 23, 2009, 10:40 amThis annex is the result of the Q4B process for the Capillary Electrophoresis General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
ICH – Press Release
Filed in regulatory, December 3, 2009, 11:05 amThe International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in St. Louis, Missouri from October 24-29, 2009. The main achievements are outlined below.
Drug Regulators Publish Q4B Annex9 & 10
Filed in Uncategorized, September 30, 2009, 10:19 amThis annex is the result of the Q4B process for the Tablet Friability General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
Drug Development Regulations – Q4B Annex
Filed in formulation, regulatory, July 16, 2009, 9:38 amEMEA publishes ANNEX 6 TO NOTE FOR EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON TABLET FRIABILITY GENERAL CHAPTER(EMEA/CHMP/ICH/379801/2009)
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