The Second All-Russian GMP-Conference with international participation has opened in Gelendzhik
On September 18, in Gelendzhik, the Second All-Russian GMP-Conference has opened. The Conference is dedicated to the current topic of inspection, compliance with the standard of Good Manufacturing Practice at pharmaceutical enterprises of the industry.
The Second GMP-Conference gathered more than 800 participants, 155 companies – this is twice more than the last year. The event, which has become traditional, brought together leading experts of the pharmaceutical industry, managers and specialists of production, representatives of line ministries and departments, associations, specialists in the field of professional development of the pharmaceutical industry staff.
The Conference program opened with press-briefing, the participants of which were: Deputy Minister of Industry and Trade of the Russian Federation Sergei Tsyb, Director
of Federal State Institute «State Institute of Drugs and Good Practices» of the Minpromtorg of Russia Vladislav Shestakov, Deputy Governor of the Krasnodar region Sergey Altukhov, Director of the Department for Medicines Supply and Regulation of Medical Devices Circulation of the Ministry of Health of the Russian Federation Elena Maksimkina, Head of the Department for organization of state control for the quality of medical products of Roszdravnadzor Valentina Kosenko, the first pro-rector of the First Moscow State Medical University named after I.M. Sechenov Andrey Svistunov, management of major companies «Pharmstandart», «Veropharm», «Aktivniy component».
«Pharmstandart» has become the General Partner of the Conference. The event has been also supported by the company «Gedeon Richter», which has become the Official Partner of the Conference.
«GMP is philosophy, culture of production that allows us to create responsibility in order to grow into super-quality, – Sergei Tsyb, Deputy Minister of Industry and Trade, – We succeeded in shaping the correct sectoral thinking in this area».
«Over one year and a half we managed to form a definite opinion to our Inspectorate. This is connected with systematic work, including serious personnel training, – said Vladislav Shestakov. – Over one year and a half, about 580 inspections of foreign medicines manufacturers were conducted. All the work that is done by our Inspectorate is not only inspecting of foreign manufacturers, it is also inspecting of Russian enterprises. It is aimed at creating reputation, so that the certificates of our inspection are trusted in other countries. Here we are currently actively working with the Ministry of Industry and Trade and the Ministry of Health of the Russian Federation on accession to the PIC/S. This will give the opportunity to interact with the inspectors of other countries on a professional basis».
A living example of such interaction has become the arrival of the Syrian Arab Republic delegation led by the Deputy Minister of Health of Syria, Dr. Habib Abboud, who presented state awards and noted the merits of the Russian Inspectorate’ representatives having conducted the inspection of Syrian pharmaceutical plants. The award was given to the staff of Federal State Institution «State Institute of Drugs and Good Practices» having conducted the inspection: Head of the delegation, Director of the Institute Vladislav Shestakov, Head of the Department for medicines production inspection Natalia Chadova and the leading specialist of the Department for medicines production inspection Vyacheslav Goryachkin.
As a part of the official Conference opening, a number of significant agreements have been signed. In particular, Veropharm (Abbott Group) announced the signing of the “Strategic Partnership Agreement” with Bion, the Russian manufacturer of pharmaceutical substances for the production of ready-made dosage forms. Within the framework of a long-term strategic partnership, high-technology substances for the production of cancer treatment medicines, as well as the cardiovascular and central nervous system would be developed. Strategic partnership will promote the development and implementation of the scientific and technological potential of the pharmaceutical industry in Russia.
«Taking care of people’s health is a fundamental of our activities. Therefore, product quality and safety are one of the key priorities of «Veropharm» (Abbott Group). We actively support the idea of introducing international quality standards in Russia and follow the best international practices in the manufacture of medicines at our plants in Russia. Modern production facilities of «Veropharm» are equipped in strict accordance with GMP standards, and we pay special attention to the selection of production partners. Our new initiative serves the development of the healthcare industry and contributes to the preservation of people’s health», – says Elena Y. Bushberg, General Director of «Veropharm» (Abbott Group).
Also on the first day of the Conference plenary sessions and panel discussions on the following topics took place: «Issues of industry regulation on the example of pharmaceutical production localization. Factors of development and regulatory obstacles», «EAEU countries integration into the international pharmaceutical system. PIC/S entry issues: main challenges, expected results», «GMP: inspection. EAEU GMP certificates mutual recognition mechanisms and support measures», «GMP: Next generation factories. GEP global trends».
«Currently there is a situation when the alignment of forces in the world could change. According to our data, already in 2018, China and India will raise substances prices for foreign markets, which is a consequence of the protectionist policies of these countries. This is a real opportunity to strengthen the positions of the pharmaceutical industry and to increase production and export volumes if we are able to create conditions for stimulating investment for the production of substances in Russia in the shortest possible time. This implies the introduction of a three-stage system of preferences, the establishment of the institute for standardization of active ingredients and impurities, and the provision of investment incentives to companies that invest in the production of active pharmaceutical substances. «Activniy component» is planning to export a third of the products in 3 years, which is about 45 tons per year», – said Alexander Semyonov, President of «Activniy component».
«I believe that this is a completely different step in the development of pharmaceutical industry in the Russian Federation, precisely correct and timely, we need to maximally integrate our capabilities into the international space», – stressed Sergei Tsyb.
- An open expert-advisory workshop on the topic «Computerized systems validation. Maintenance of their validated status» to be held on 15-16 November, 2018
- An open expert-advisory workshop on the topic «Water-treatment in pharmaceutical production in view of up-to-date regulatory requirements and trends» to be held on 8-9 November, 2018
- Representatives of FSI «State Institute of Drugs and Good Practices» took part in the GEP-Russia International Conference in Moscow
- Delegates of FSI «SID & GP» of the Ministry of Industry and Trade of Russia with an official visit to Singapore towards experience sharing
- Inspectors of the State Institute of Drugs and Good Practices participated in a mock GMP inspection