Final Report: Laboratory Training Courses for the Staff of Roszdravnadzor’s National Network of Medicines Quality Control Laboratories
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The Promoting the Quality of Medicines (PQM) Program, implemented by the United States Pharmacopeia (USP), in collaboration with Roszdravnadzor (RZN), the Food and Drug Administration of the Russian Federation, developed laboratory training courses for the staff of RZN's national network of medicines quality control laboratories.
2012 · 13 pages

Abstract
The training courses were conducted in Saint Petersburg, Russia, from October 15 to 18, 2012. The training courses focused on microbiological aspects of medicines quality control, disinfectants and antiseptics, and pyrogen testing. Three training courses were developed to suit the needs of the RZN staff and were translated into Russian by experts in relevant fields. The training courses were attended by 14 individuals representing eight regional/federal district labs, who were hosted at Roszdravnadzor's Saint Petersburg Medicines Quality Control Laboratory. The training courses aimed to provide participants with competency in basic and advanced microbiological methods of quality control, including identification of antimicrobial effectiveness, determination of microorganism quantities, testing for specific microorganisms, sterility and pyrogen testing, and identification of microorganisms and their properties. By the end of the training, participants gained a comprehensive understanding of the importance of appropriate pyrogen testing and other microbiological methods in medicines quality control. The training courses were conducted as part of USAID close-out activities, and the trip was supported by USAID/Russia. To minimize costs, RZN covered expenses for its participants, including travel and accommodations, and provided the training venue. The training courses were organized by PQM, USAID Russia, RZN, Information and Methodological Center for Expertise, Stocktaking and Analysis of Circulation of Medical Products (IMCESACMP), and Saint Petersburg MQCL. The trainers for the training courses were Dr. Radhakrishna Tirumalai and Mr. Pradeep Ganganala, who provided the participants with hands-on experience and practical knowledge in the field of microbiological quality control. The training courses were well-received by the participants, who showed great interest and enthusiasm for attending other courses, including courses on microbiological issues. The training courses were equipped with necessary equipment, including Ready Depyrogenated 10 x 75 mm borosilicate glass test tubes, Ready Depyrogenated 13 x 100 mm borosilicate glass tubes, and USP reference standards. The training courses were concluded with a closing ceremony, where certificates were provided to the participants, and Dr. Radhakrishna Tirumalai, Mr. Pradeep Ganganala, and Dr. Kirill Burimski spoke during the closing ceremonies. The PQM Program is USAID's response to the growing challenge posed by the proliferation of counterfeit and substandard medicines. By providing technical leadership to developing countries, PQM helps build local capacity in medicine quality assurance systems, increase the supply of quality medicines to priority USAID health programs, and ensure the quality and safety of medicines globally.
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USAID DEC