biopreparatБИОпрепараты. Профилактика, диагностика, лечениеBiological Products. Prevention, Diagnosis, Treatment2221-996X2619-1156Scientific Centre for Expert Evaluation of Medicinal Productsbiopreparat-109Research ArticleОБЗОРЫREVIEWSАнализ стабильности показателей качества биологических лекарственных препаратов при проведении испытаний в рамках подтверждения соответствияTrend analysis of batch to batch consistency during quality assessment of biological medicinal productsДавыдовД. С.DavydovD. S.

Начальник лаборатории бактериофагов и препаратов нормофлоры с коллекцией микроорганизмов Испытательного центра экспертизы качества МИБП, канд. биол. наук

Head of the Laboratory of Bacteriophages and Normal Flora Preparations with the Collection of Microorganisms of the Testing Centre for Evaluation of Medicinal Immunobiological Products’ Quality. Candidate of Biological Sciences

Davydov@expmed.ruНаучный центр экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation201720022018174230232Copyright © Давыдов Д.С., 20182018Давыдов Д.С.Davydov D.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.biopreparations.ru/jour/article/view/109

Статистический анализ закономерностей количественных данных, получаемых в результате лабораторной экспертизы, является одним из важнейших элементов обеспечения качества. В равной степени анализ трендов необходим при подтверждении соответствия биологических лекарственных препаратов требованиям нормативной документации и для обеспечения достоверности лабораторных испытаний. В статье кратко рассмотрены позиции Всемирной организации здравоохранения и Международной организации по стандартизации по вопросам анализа трендов при выпуске биологических препаратов, в частности, вакцин, а также методическим подходам к планированию и организации процедуры выборочного контроля.

The statistical analysis of trends in the quantitative data obtained during laboratory evaluation is one of the most important conditions of ensuring quality. Equally, the analysis of trends is necessary to confirm the compliance of biological medicinal products to the requirements of manufacturers’ quality standards and to ensure the reliability of laboratory tests. The article briefly surveys the positions of the World Health Organization (WHO) and the International Organization for Standardization (ISO) on the analysis of trends in the production of biological medicinal products, especially vaccines, as well as on methodological approaches to the planning and organization of random sampling checks.

управление качествомбиологические лекарственные препаратывакциныподтверждение соответствияконтрольные картыquality managementbiological medicinal productsvaccinesconformity assessmentcontrol chartsReferencesФедеральный закон от 12 апреля 2010 г. № 61-ФЗ «Об обращении лекарственных средств».Federal Law of April 12, 2010 ¹ 61-FZ «On Medicine Circulation» (in Russian).Основы государственной политики в области обеспечения химической и биологической безопасности Российской Федерации на период до 2025 года и дальнейшую перспективу (утв. Президентом Российской Федерации 1 ноября 2013 г. № Пр-2573).Bases of state policy in the field of ensuring chemical and biological safety of the Russian Federation until 2025 and further prospect (approved by the President of the Russian Federation on November 1, 2013 ¹ Pr-2573) (in Russian).Миронов АН, Супотницкий МВ. Современное состояние экспертизы иммунобиологических лекарственных препаратов в Российской Федерации. БИОпрепараты. 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The authors declare that there are no conflicts of interest present.