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AO "Pharm-Sintez" obtained the certificates for compliance with the requirements of the international standards of the quality management system ISO 9001: 2008 and ISO 9001: 2011.


We are pleased to inform you that AO "Pharm-Sintez" confirmed the compliance with the requirements of the international standards ISO 9001: 2008 and ISO 9001: 2011 of the quality management system. The certificates ISO 9001: 2008 and ISO 9001: 2011 were obtained in the field of manufacture, testing and release of drugs into the market (pharmaceutical substances produced by the chemical synthesis methods, sterile drugs: lyophilizated products, injectable solutions, non-sterile medicines, and sprays).

Certificate ISO 9001:2008.pdf

Certificate ISO 9001:2011.pdf

ISO is the International Organization for Standardization, ISO. The standards are adopted as national ones by more than 140 countries worldwide. The ISO 9000 standards provide universal requirements for how the quality management system of the company should be built in order to provide high quality products or services. The requirements of the standard ISO 9001: 2008 are applied to all the aspects of the company management system: senior management of the enterprise, marketing, designing of products or services, personnel management, supply of resources, etc. During the implementation of the quality management system, the company's processes are described, their interaction is determined, criteria and methods that increase the effectiveness of the process management are established, and a system of monitoring, measurement and analysis of processes is developed and implemented. The mechanisms of continuous improvement of the company are implemented. The compliance of the company’s Quality Management System (QMS) with the ISO 9001: 2008 requirements is confirmed by an independent certification body during the audit.