Strict GMP standards should guarantee quality of pharmaceutical products at production stage and should prepare Russian companies to enter international markets. Launch environment for practical implementation of GMP standards vary significantly among manufacturers: in terms of managerial and technological preparedness, corporate culture and training of personnel, budgets available for investment into development of quality assurance systems. Existing SOP developed by businesses before the GMP introduction, in many cases, conflict with the modern regulations and create critical discrepancies in terminology. These and other issues require systematic support for Russian pharmaceutical manufacturers in the acceptance and implementation of GMP.
The State Institute of drugs and Good Practices, as an authorized regulator for inspecting foreign pharmaceutical manufacturers for humans, possesses unique experience in practical application of GMP standards (998 inspections by mid-2018). Analysis of this hefty expertise and projects of its formalization make the Institute one of the leading competence centers in streamlining life cycle of medicines. This is the key note of our educational mission implemented in cooperation with the Peoples’ Friendship University of Russia, the First Moscow State Sechenov Medical University, and other academic communities.
At the end of 2017, the Institute of Drugs and Good Practices with the support of «PharmStrategia» LLC laid out a Roadmap for Introduction of Good Practices in the Russian pharmaceutical industry. The project was aimed at deep analysis of inspectors’ feedback and obtaining new competences, research of complex cases associated with the application of GMP standards, preparation of training modules and case studies, as well as further transfer of the project results on to Russian market. The strategic goal of the Roadmap is development and technological transformation of the Russian pharmaceutical industry. The first project activities were held in November 2017 and received positive feedback from the participants. The program is open for everyone and is a prototype of the future educational platform. To implement this idea, the Institute came up with www.goodpractices.ru, which provides an opportunity for both corporate and individual users to create training courses for their purposes. Educationalists have a good chance to participate in their implementation.
An in-house training center made it possible for the Institute of Drugs and Good Practices to actively propel its educational mission. The Institute’s Scientific and Training Department makes great efforts to improve inspectors’ competences: not only in terms of the professional skills required for audits, but also aimed at developing «soft skills», e.g. task-specific communications and public speaking. Experts of the Institute take part in international training programs offered by WHO, PIC/S, ISPE, PDA, and ICH – both as students and facilitators. In June 2018 our inspectors launched a training and professional exchange project with their peers in the Eurasian Economic Union.
Calendar-thematic plan of open consulting seminars 2018-2019