At the II All-Russian GMP-Сonference told what is good and what is bad in the pharmaceutical industry
The II All-Russian GMP-Сonference with international participation is in progress in Gelendzhik. Presentation of the book «What is good and what is bad in pharmaceutical production» opened the 2nd Conference Day. The book was presented by its authors – Director of FSI «State Institute of Drugs and Good Practices» of the Ministry of Industry and Trade of the Russian Federation Vladislav Shestakov and D. Ph.S., professor Yuriy Podpruzhnikov (National Pharmaceutical University, Department of Quality Management (Ukraine).
The book is aimed at both students and teachers of pharmaceutical colleges and specialized faculties of higher education institutions, as well as industry employees with the purpose of advancing their qualification. Its authors noted that the monograph is both a textbook and a reference book for professionals of the pharmaceutical field, and may be of interest to a wide range of medical workers, as well as patients who are interested in the quality of medicines issues. It describes the current Good Manufacturing Practice rules, analysis of their promising changes, and the results of regulatory authorities of different countries inspections.
The book was first presented to a vast professional audience, and kindled great interest from the GMP-Conference participants. For the first publication copies, which the authors were signing, a queue lined up.
The second day of the event continued with plenary sessions, which were devoted to the international regulatory practices, new approaches and relevant solutions in the field of pharmacovigilance. The topic of medicines labeling, as well as the approaches of regulators, medicines developers and holders of registration certificates to pharmacovigilance, was also raised at the conference discussion site.
The topic of the first day of the conference – development of export potential and integration into the international space – also continued. In particular, at the panel session «Opportunities for new markets. Strategic Dialogue the cooperation of Russian pharmaceutical companies with the Syrian Arab Republic was discussed.
«We have a good history of the pharmaceutical industry development, – said Habib Abboud, Deputy Minister of Health of the Syrian Arab Republic, – We hope for a trustful friendship with the Russian side. We have similar regulatory requirements. There is great potential for mutually beneficial cooperation. We would like to unite our economies, as far as it is possible». In the framework of negotiations Alexander Semyonov, the President of «Active Component» company (the leading company in production of active pharmaceutical substances in Russia), said:
«The important priority for the development of our company is export of products to the new markets. This is quite a promising prospect in the light of the establishment of the institution of mutual recognition of quality certificates between Russia and Syria. We are at the stage of negotiations with the manufacturer of finished pharmaceutical products in Syria and a large distributor supplying products to a number of countries in the Middle East. We hope that our cooperation will become a “bridge” to mutually beneficial relations between our countries. We have a high potential for the foreign direction development: in the next few years we plan to increase production volumes to 140 tons per year and extend a list of products to 100 items. This include, but not limited, modern innovative generic drugs, and popular positions, for example, antibiotics».
The company «Farmimex» is currently actively building new production facilities for the manufacture of blood products, and finds the cooperation with Syrian enterprises in this area possible.
Habib Abboud noted the need in pharmaceutical products manufactured by Russian enterprises, and mentioned that such «counter motion» could grow into joint projects.
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed
- Pharma is under control