Quality of Otcpharm products

OTCpharm cares about the quality, safety and effectiveness of the manufactured drugs. The quality management system in effect at the enterprises has been developed and implemented in accordance with the requirements of international and national standards. Modern, innovative technology and equipment are integrated into all our production sites.

GOST R 52249–2009 (GMP)
Rules for the production and quality control of medicines
GOST R ISO 9001-2008 (ISO 9001:2008)
Quality management systems. Requirements.

Security marking

Each drug is labeled in accordance with the current legislation of the Russian Federation. The labeling system ensures the identification of drugs and guarantees the authenticity of pharmaceutical products.

The quality management system is regulated in accordance with regulatory documents:

Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 77 «On Approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union» (GMP)

Federal Law No. 61-FZ of April 12, 2010 «On the Circulation of Medicines»

Decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 80 «On Approval of the Rules of Good Distribution Practice within the Framework of the Eurasian Economic Union» (GDP)