SID&GP and Thai FDA will conduct a joint inspection
On August 15, the meeting between national GMP-inspectorates took place at the Russian-Thai Business Forum venue, organized by the Ministry of Industry and Trade of the Russian Federation. Thai FDA and SID&GP have agreed upon closer cooperation, in particular the representative of Thai inspectorate stated that they are ready to participate as observers in the inspection of the local site, which will be conducted next week.
This year’s Russian-Thai business forum has been quite eventful for the pharmaceutical industry. National companies not only met with the premier Thai distributors, interested in representing Russian products on their markets, but also organized a productive discussion with manufacturers and regulators, while the GMP-inspectorate of the two countries held a closed working meeting. Until now, there had been no cooperation between inspectorates – inspections of manufacturing sites were carried out without national regulators’ presence, thus the results of the inspections were unsatisfactory. According to Vladislav Shestakov, Deputy Head of the Russian state GMP-inspectorate and Director of the State Institute of Drugs and Good Practices (SID&GP), from 2016 to 2019 out of three inspections conducted, two manufacture sites were refused to obtain a GMP certificate. Among the non-conformities that have been identified at both manufacturing sites are violations of GMP rules during the validation of the packaging process (not all stages of the process are included in the validation work). The Thai regulator was provided with a complete list of non-conformities based on the work carried out by the Russian GMP inspectorate. This list has been carefully examined by Patchareewan Phungnil, Acting Head of Biological Products Section, Post-marketing Control Division, Bureau of Drug Control, Thai FDA.
“Insufficient level of interaction between Russian and Thai regulators leads to the fact that pharmaceutical manufacturers often do not understand the sequence of actions during GMP-inspections and the action plans in case of refusals to issue a certificate of GMP compliance”, – noted Vladislav Shestakov. As a result, Pramote Akarapanon, Head of Biological Products Section, Pre-marketing Control Division, Bureau of Drug Control, Thai FDA wished that Thai FDA inspectors would participate in the upcoming inspection to be carried out by the SID&GP in Thailand at the end of August.
At the meeting, regulators described the peculiarities of national regulatory systems of medicines and the GMP-inspectorates work. In particular, Thai FDA noted that unlike the Russian colleagues, whose inspectorate employs 80 inspectors, the inspectorate of Thailand is much smaller and is represented by only 30 specialists. At the same time, unlike Russia, Thai regulatory system of medicines is more centralized, consequently a significant part of the bilateral meeting between Thai FDA and SID&GP was devoted to clarifying the structure of medicines regulation in Russia and cooperation between the Ministry of Health of the Russian Federation, Federal Service for Surveillance in Healthcare, the Ministry of Industry and Trade of the Russian Federation, the Ministry of Agriculture of the Russian Federation and their relevant subordinate institutions (Scientific Centre for Expert Evaluation of Medicinal Products and SID&GP).
As a result of bilateral negotiations between Russian and Thai inspectorates, Thai FDA and SID&GP agreed upon organizing the GMP training inspections at Thai manufacturing sites and Thai FDA inspectors participation in the GMP inspections conducted by SID&GP as observers. Taking into account the demand for public analytical information about the market, manufacturers and pharmaceutical products, formed by the Russian pharmaceutical companies that came to the Russian-Thai business forum, the regulators plan to organize their analytical and consulting centers work in this direction. The international information project “GMP News” and the All-Russian GMP Conference with international participation, in which Thai FDA plans to take part, can be used as public platforms for analytical materials distribution.
- What is in the Programme of V GMP-conference?
- 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