Company group Production Distribution Pharmacy chain news Contacts general information Quality service Pharmacovigilance Proposal of collaboration Quality above all Quality assurance of drugs sent to the consumer: continuous assurance of safety and efficacy of manufactured medicines, reliable verification of manufactured drugs, up-to-date documentation and regular self-inspection. Quality service Quality policy The management of Pharmacist LLC chooses the following quality policy. goal Striving to become a leader in its industry and focusing on international standards, both in the field of quality management and in the field of industry standards, Pharmacist LLC defines the main goal of its activities in the field of quality: production of products of proper quality that meet the requirements and expectations of consumers. Quality objectives Certification of all production for compliance with the requirements of the Good Manufacturing Rules (GMli), building a Pharmaceutical Quality System based on the principles of the International Organization for Harmonization (ICH Q8, ICH Q9 and ICH Q10). Taking into account and meeting the needs of personnel in increasing the level of competence and training Continuous analysis and improvement of the company's performance in comparison with the activities of competitors and customer requirements Methods The fulfillment of these tasks is ensured by: personal responsibility of the management of LLC "Pharmacist" headed by the director to consumers for the quality of products; the personal responsibility of each employee of the enterprise for the quality of products within their competence. The company's management is confident that the quality management system, which is being implemented at the Pharmaceuticals LLC enterprise, is the basis for the production of products of proper quality and their continuous improvement. The company has created, implemented and is constantly improving a quality system in accordance with the current national standards and the requirements of the legislation of the Russian Federation. The system is aimed at ensuring and constantly maintaining the proper level of quality of manufactured products and compliance with the requirements of current good practices in systems: quality assurance, production, quality control, packaging and labeling, premises and equipment, logistics. The company's quality service is a key division that takes part in decision-making in the design of new production sites, modeling and optimization of business processes. The quality service guarantees: Manufacturing processes and equipment are validated to meet the most stringent criteria; Quality control methods are validated to ensure their reliability; The staff is highly qualified and undergoes periodic training with regular verification of knowledge; The system of continuous improvement functions properly and is integrated into the processes and procedures, while the company staff is motivated to generate innovations. Quality control is part of the company's quality service, the key role of which is: контроле качества всех видов сырья и материалов, используемых в производстве; контроле качества продукции на всех стадиях производственного процесса согласно требований технологического регламента; исключение любых отклонений в процессе путем своевременного проведения корректирующих действий; контроле санитарного состояния производства; апробации и верификации аналитических методик контроля качества препаратов; разработке и валидации аналитических методик. Данные задачи решаются с помощью высококлассного аналитического оборудования таких производителей как: BISCHOFF, SOTAX, САМАG, SCINCO. Контролю подлежат также условия производственной среды, чистота помещений и оборудования, качество очищенной воды, применяемой в производстве. Действующей в компании система управления качеством гарантирует, что выпускаемый продукт всегда соответствует специфицированным для него требованиям. В рамках системы управления качеством на производстве функционируют процедуры: управление отклонениями и изменениями, система самоинспекций для проведения регулярных проверок система оценки и утверждения поставщиков сырья и материалов, проведение внешних аудитов, система корректирующих и предупреждающих действий, рассмотрение рекламаций и работа с возвращенной продукцией. Решение о выпуске продукции в обращение принимает Уполномоченное лицо только при условии отсутствия замечаний к процессу производства и качеству готового продукта. 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