SID&GP will audit 500 enterprises in 2017

| By | GMP Inspectorate, Pharmaceutical Manufacturing, Shestakov

At the XII International Conference “Pharmaceutical Business in Russia: a promising scenario for the development of pharmaceutical market for 2017” Vladislav Shestakov, Director of the State Institute of Drugs and Good Practices, has shared his assessment and conclusions regarding one year functioning of an institute for inspection of foreign production sites.

In particular, Vladislav Shestakov referred to the expertise of European colleagues who undertake up to 200 inspections per year all over Europe. He emphasized, that for the first year of its work SID&GP has already performed 188 inspections and the audit of 500 enterprises is scheduled for the current year.

“As of now, the number of inspectors amounts to 42 experts. In course of the whole inspection period we have issued 127 reports and 44 enterprises have received negative conclusions, – commented Shestakov. — We carry out active training of our experts on an ongoing basis contributing sufficient funds to their training and upgrade of professional skills. For instance, in March we plan to re-start a two-stage specialists training program; the first stage will take place in Russia and the second at Danish Centre Pharmacom, our long-standing partner. It should be mentioned that we are open for cooperation: we invite our colleagues to join the training program along with the employees of the institute and the Ministry”.