Current State of Harmonisation (EP/USP/JP)

The EDQM (European Directorate for the Quality of Medicines & HealhCare) has published the outcomes of a meeting of the Pharmacopoeial Discussion Group (PDG) which took place on 8 and 9 November 2011 in Strasbourg, France.

According to this publication, 28 of the 35 General Chapters and 41 of the 61 excipient monographs of the current work programme have been harmonised at present - among them also the revision to the Carmellose monograph. At the same time, it has been decided to stop activities for harmonising requirements on Glyceryl Monostearate as significantly different types are manufactured in the three regions.

Another meeting took place on 8 November 2011 with the IPEC (International Pharmaceutical Excipients Council Federation) and dealt with topics regarding cellulosics, viscosity of cellulose derivatives. Please also see the press release "Pharmacopoeial Discussion Group Achievements" about the PDG meeting.

In the overview "PDG State of Work" you will find more about the group's current status (December 2011). You can further find a projected timetable including dates for the implementation of each General Chapter and Monographs in the three regions in the past and also for the current year 2012.

The testing of metal impurities, the particularities of testings laid down in the Japanese Pharmacopoeia as well as the handling of varying specifications in different Pharmacopoeias in the pharmaceutical quality control will be the most important topics dealt with at ECA's Conference "Compliance Update: EP, USP, JP" taking place on 21-22 June 2012 in Prague.

Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)