Quality Management Department

Quality Management Department
Marina P. Chepurnaya
Contact details: 

Tel:8 (4922) 26-15-12
Ext. 2-226

Basic activities:
- quality management system improvement and maintenance according to national and international standards GOSR R ISO 9001-2008 using industry standard GOST R 52249-2009 “Rules for Production and Control of Drug Quality”;
- coordination of activities of units engaged in quality management system maintenance;
- rendering consultative assistance to personnel in preparation and approval of technological regulations and other regulatory and technical documents (FSP, SOP, STO, TU, instructions);
- expertise of regulatory and technical documents;
- preparation of documents for bar code assignment to manufactured products under unified identification system (UNISCAN/ G1 RUS);
- preparation of registration dossiers and other documents and materials for submission to the Rosselkhoznadzor;
- preparation of documentation for drug certification;
- conduction of internal inspections (audits) of compliance with QMS requirements and RF standards;
- licensing of drug manufacturing and pharmaceutical activities;
- dispatching control system of technological process parameters and equipment.

“Quality Management System” Certificate No.ROSS.RU.001.13 FK 11, valid till 07.12.2012, was obtained.