GMP inspections master class Best Practices Day at the III All-Russia GMP Conference
The Best Practices Day on August 29 – the final day of the III All Russia GMP Conference – will begin with a master class on GMP inspections, at 9:00 in the Pushkin Hall, of the Korston Club Hotel business center in Kazan. Natalia Chadova – Head of the Department for Inspection of Medicines and Expertise at the State Institute of Drugs and Good Practices of the Russian Ministry of Industry and Trade – will moderate the activity.
During the master class, we will review GMP audit management, results of inspections of Russian and foreign manufacturers, important issues pertaining to GMP inspections: most common deviations, CAPA, Russian GMP inspections of foreign manufacturers from the viewpoint of an independent expert, a case study of a follow-up GMP inspection of a manufacturer.
For the third year in a row the Russian Ministry of Industry and Trade in cooperation with the State Institute of Drugs and Good Practices organize the conference, and GMP inspections play the key note every year. It is notable that the number of questions is growing even though most production sites have already been inspected or are preparing for follow-up inspections.
Expert report that more than 112 companies (from 38 countries) can re-submit an application for a GMP certificate until the end of 2018. Consequently, the State Institute of Drugs and Good Practices keeps receiving questions about repeated inspections. To develop a better program for the master class, all participants of the conference are invited to take a survey on the official web site. The received data will help us better prepare the event and circle out current issues and questions of the industry for a discussion.
- The volume of Indian drugs in the Russian market was $770 mln in 2018
- Mr. Vladislav Shestakov called for taking a quantum leap in GLP
- Interaction points were discussed by SID & GP with EDQM
- The inspection of the foreign pharmaceutical company registering its drug product in Kazakhstan was carried out by the Russian Inspectorate
- 157 license holders out of 189 manufacturing sites have received a GMP-certificate following the procedure of filing an application