Tag Archive
The following is a list of all entries tagged with PDG:
FDA, the USA Drug Regulator, Published Q4B Evaluation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 14: Bacterial Endotoxins Text General Chapter
Filed in manufacturing, July 27, 2010, 10:29 amThis annex is the result of the Q4B process for the Bacterial Endotoxins Test General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
FDA, the US Drug Regulator, Publishes Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions, Annex 13: Bulk Density and Tapped Density of Powders General Chapter
Filed in manufacturing, July 20, 2010, 9:32 amThis annex is the result of the Q4B process for the Bulk Density and Tapped Density of Powders General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).
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, EMEA, Publishes ICH Q4B Annex 11, Capillary Electrophoresis General Chapter Guidance
Filed in manufacturing, December 29, 2009, 10:47 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).
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).
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