IMPURITIES IN STARTING MATERIALS AND MEDICINAL PRODUCTS - SEMINAR OF THE INTERNATIONAL-ASSOCIATION-FOR-PHARMACEUTICAL-TECHNOLOGY (APV) HELD ON JUNE 1ST AND 2ND, 1992 IN D-BAD HOMBURG

The 1st International Conference on Harmonization (ICH) regarding marketing authorization of medicinal products was held in Brussels in November 1991 and drew attention to the areas which are urgently in need of harmonization. These include the various types of and limits for residual solvents, the question when toxicological studies on degradation products should be submitted as well as the matter of establishing recognized criteria for laying down limits for impurities with respect to applications for marketing authorization and monographs. These topics are to be dealt with during a follow-up conference to be held in Orlando, FL in October 1993 in tripartite discussions between the European Community, Japan and the USA. In laying the groundwork for the clarification of the problem of impurities, their current status in starting materials and medicinal products was looked at from the viewpoint that harmonization cannot be achieved simply with individual assessments but only by taking into account all the opinions expressed. The seminar was led by Dr. A. Wachter of Ciba-Geigy AG, Basle and Dr. B. Weber of Bayer AG, Leverkusen.