The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Round table conference “Current trends in the inspection of the production of medicines for compliance with GMP”

A round table conference was held in Moscow on the topic “Current trends in the inspection of the production of medicines for compliance with GMP requirements” on June 27, 2017. The co-organizers were the Association of International Pharmaceutical Manufacturers (AIPM) and the European Federation of Pharmaceutical Industry and Associations (EFPIA). The event was held with the support of the Federal State Institution “State Institute of Drugs and Good Practices” (FSI “SID&GP”).

The event was participated by: the Senior Director Regulatory Affairs  and Healthcare Policy AIPM Elena Popova, Director of FSI “SID & GP” Vladislav Shestakov, Head of the Department for Inspection of Vedicines and Expertise  Natalia Chadova (FSI “SID & GP”), Adjunct professor at George University Washington DC (USA) Dr.Stephan Rönninger, ex-Director of Quality Department, Ex-Chief GMP Inspector of the French National Agency for Drug Safety Dr. Lina Ertle (ANSM), Chairman of the Investment Policy and Logistics Committee Mikhail Khazanchuk (AIPM, J & J, Russian Federation), representative of the Center of Scientific Advice – Ravil Niyazov, GxP-expert, Helga Peters (F. Hoffmann-La Roche Ltd).

Elena Popova while opening the round table noted that the purpose of this event is to discuss current trends in GMP,: inspection, current practices and procedures, the most actual problems, as well as the possibility of using risk-based approaches in implementing state control and perspectives for embedding national regulatory system to the global regulatory agenda.

“Production is a key element in the life cycle of a drug, but it is inextricably linked with other stages of its circulation, such as development, registration, and others, controlled and supervised by several authorized state agencies. Today’s event is a dialogue between the industry and regulation agencies, and, equally important, it is a dialogue between regulators and expert organizations among themselves, ”- Elena Popova emphasized.

A variety of issues were discussed during the sessions: the organization and performing of the inspections in Russia and in the countries of the European Union, differences and similarities, categorization of the most frequently detected inconsistencies, regulatory experience of different countries, the development of the industry, growth prospects and interaction between the inspectors of different countries.

Special attention was paid to the work of the Russian GMP inspectorate: V. Shestakov spoke about the achievements of the inspectorate since its authorization (the end of 2015), showed figures and shared the work plans for the near future. N. Chadova told about the preparation and performing of inspections

“Preparations for the inspection should take place both in the institute (FSI “SID & GP”) and on the manufacturing site itself. Applicants should pay particular attention to the accuracy of the statement and of the list of products to be inspected. Our experience has shown more than once that this list is being revised several times during the preparation. We draw the attention of representatives of foreign manufacturers once again to the fact that it must be finally agreed by all interested parties within the company before the inspection (before signing the agreement and the inspection plan) – this will help to avoid unnecessary tension.

The preliminary visit of representatives of the production company to manufacturing site- is another important element in the “waiting for the inspector” strategy.

They should independently verify the possibility and timeliness of the inspection during the visit (for example, check that the manufacturing site is located at the stated address, functioning and is not closed for reconstruction). The training of inspectors is our task, the preparation of the site and documents is the task of the inspected side.”

In addition, N. Chadova talked about the regulatory framework, the main documents, the timing of inspections, the most frequently detected mistakes, as well as the future of the Russian GMP inspectorate and, in particular, that a great deal of internal work is underway to switch to the Rules of Good Manufacturing Practices, approved within the EAEU.

Participants were asked to make out the most frequent comments on the results of inspections at the end of the event together with industry experts.