In October 2, 2019, experts from FSI SID & GP took part in the training of Nicaragua’s Ministry of Health representatives. The training was held in the format of advanced training course dedicated to the “Legal and regulatory framework for immunobiologicals’ circulation: Russian Federation Experience and Prospects for Development” topic at the premises of Federal State Unitary Enterprise (FSUE) St. Petersburg Scientific Research Institute of Vaccines and Serums and Biopharmaceutical Plant (SPbSRIVS) under Federal Medical Biological Agency of Russia.
In accordance with the Intergovernmental Russian-Nicaraguan Commission on Trade, Economic, Scientific and Technical Cooperation decision and recommendations, FSI “SID & GP” training department specialists held the advanced training course for Nicaragua’s Ministry of Health representatives on the topic: “Legal and regulatory framework for immunobiologicals’ circulation: Russian Federation Experience and Prospects for Development”. The seminar was dedicated to the qualification of clean rooms and medicines manufacturers’ equipment.
The training focus was on the quality risk management, regulatory issues, practical implementation of regulatory requirements, as well as the experience of inspecting foreign manufacturers of medicines in the context of qualification of clean rooms and equipment.
In particular, Head of section for training and development of the inspectorate of FSI “SID & GP” Ivan Gulyaev gave an overview of examples of the GMP non-conformities
in the field of qualification of clean facilities and equipment, whereas Deputy head of section for training and development of the inspectorate Anton Avramenko presented detailed GMP requirements for the qualification of technological equipment and gave recommendations on their practical implementation. Furthermore, Manager of the project group of the engineering and project section Svetlana Litvyakova, speaking about the classification and qualification of clean facilities, has drawn the course participants’ attention towards HVAC – technologies for supporting the safe and comfortable temperature parameters, humidity and chemical composition of air in the indoor facilities.
The seminar participants have discussed with great interest practical situations and highly appreciated the presented training course, expressing confidence that cooperation between Russia and Nicaragua in the field of training and development of the experts in the pharmaceuticals is conducive to raising the level of professionalism, harmonization of the regulatory requirements, which ultimately has a positive impact upon the quality of the provision of medicines for people from all over the world.