Regulatory Challenges in the CIS and Russia - TOPRA In CEE WebinarNovember 22, 2023
Inpharmatis Team Visited PharmTech & Ingredients Exhibition
Inpharmatis Russia visited the exhibition and participated in the industry conference.
Pharmtech & Ingredients is the largest international exhibition in Russia, which is held annually in Moscow at the end of November. The exhibition has attracted a wide range of manufacturers of pharmaceutical manufacturing equipment, active and functional pharmaceutical ingredients, various services for drug manufacturers are presented.
At the exhibition, Inpharmatis representatives held several meetings with pharmaceutical manufacturers. The sides discussed cooperation for registration of medicines in accordance with the EAEU requirements, conducting GMP audits of facilities, user testing of patient information leaflets, as well as electronic solutions for quality management and preparation of the electronic registration dossier (eCTD) for submission.
During the conference participants discussed, among other things, changes in the conduct of GMP inspections. Vladislav Shestakov, Director of State Institute of Drugs and Good Practices noted, “to date, about 600 remote inspections have been carried out. Remote inspections are organized mainly for hosting sites where a face-to-face inspection has already taken place earlier. A risk-based model is used, which minimizes risks. For remote inspections, it is necessary to comply with a number of requirements, first of all, data security. "
Inpharmatis’ experts noted that the company has extensive experience in organizing GMP inspections both for certification in accordance with the EAEU requirements and for obtaining a European GMP certificate, including in a remote format. To ensure data integrity and security in full compliance with regulatory requirements, Inpharmatis offers advanced electronic quality management systems (eQMS) to its customers.
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