In mid-November, the European Directorate for the Quality of Medicines (EDQM) reported that the Pharmacopeial Discussion Group (PDG) has completed harmonization of 28 of the 35 General Chapters and 41 of the 61 excipient monographs in its current work program.
Formed in conjunction with ICH, the members of the PDG are the European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP) and the US Pharmacopeia (USP).
At the PDG meeting in early November in Strasbourg, France, a revision to the carmellose monograph was approved, while in-depth discussion of advanced drafts of certain cellulosics and carbohydrate monographs “will pave the way for future sign-offs,” according to the EDQM announcement. Following consideration of the significantly different types of glyceryl monostearate material manufactured in the three regions, PDG decided to remove this item from its work program.
Representatives from the three pharmacopoeias discussed other topics at the meeting, including microbiological limits, metal impurities and the progress made in the on-going review of previously signed-off monographs to achieve a higher degree of harmonization.
Also at the meeting, PDG representatives met with the International Pharmaceutical Excipients Council (IPEC) Federation.
Discussion topics included cellulosics, viscosity of cellulose derivatives, polyethylene glycol, glycerin, povidone, copovidone, the silicon dioxide monographs, and metal impurities. In addition, means to further strengthen collaboration between the groups and the potential to add additional excipient monographs to the work plan were explored.
PDG representatives meet monthly via teleconferences. The next face-to-face PDG meeting will be hosted by the Japanese Pharmacopoeia in 2012 in Tokyo, Japan.
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