REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot117810.21518/1561-5936-2019-12-44-53Original ArticleInternational approaches to the formation of the quality system of the pharmaceutical inspectorateNikolenkoN. S.ivashechckova@yandex.ruBeregovykhV. V.ber2742@gmail.comI.M. Sechenov First Moscow State Medical University (Sechenov University)1212201912445318032022Copyright © 2019,2019In most countries  pharmaceutical market is regulated by the state in order to provide the population  with high-quality, safe and effective medicines.Pharmaceutical inspection  for compliance  with the requirements  of any good practice  in the field of drug circulation is one of the main components  of national regulatory  system.Modern organization of pharmaceutical inspectorate involves presence of a quality system. Development and operation of such a system is not an easy task.In the review, the authors  analyzed  main international  approaches  and directions of normative  regulation  of the quality system for pharmaceutical inspectorate,  examined  the requirements  of ISO  9000  standard  for creating  quality management systems  in organizations, and proposed a model of the quality system of pharmaceutical inspectorate based on the process  approach.GMP rulesmedicinesinspectoratequality controldrug industryправила GMPлекарственные средстваинспекторатконтроль качествафармацевтическая промышленность1.Чукреева Н.В. Исторические этапы эволюции систем обеспечения и контроля качества лекарственных средств. Ремедиум. 2016;(6):44-49. doi: 10.21518/1561-5936-2016-6-44-50.2.Береговых В.В., Мешковский А.П. Нормирование фармацевтического производства. М.: Ремедиум; 2001:55-60.3.WHO Technical Report Series. Annex 8. Quality systems requirements for national Good manufacturing practice inspectorates. №902. 2002. Avaliable at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QualitySystemRequirementsNationalGMPInspectoratesTRS902Annex8.pdf (accessed date: 17.11.2019).4.World Health Organization (WHO): official website. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory system of medical products, national regulatory system (RS): Indicators аnd Fact Sheets. Avaliable at: https://www.who.int/medicines/areas/regulation/01_GBT_RS_RevVI.pdf?ua=1 (accessed date: 17.11.2019).5.World Health Organization (WHO): official website. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory system of medical products, Regulatory Inspection (RI): Indicators and fact Sheets. Avaliable at: https://www.who.int/medicines/regulation/06_GBT_RI_RevVI.pdf?ua=1 (accessed date: 17.11.2019).6.Мешковский А.П. Роль инспектирования производителей лекарственных средств на соответствие надлежащей производственной практике в обеспечении качества лекарственных препаратов на рынке. Медицинские технологии. Оценка и выбор. 2016;(1):81-88.7.Гэд Ш.К. Справочник. Производство лекарственных средств. Контроль качества и регулирование. Практическое руководство. Береговых В.В. (ред.). Спб.: Профессионал; 2013:29-76.