The quality system covers all production stages of pharmaceuticals: from thorough incoming control of substances, excipients, packaging, air and water conditions and other engineering environment, staff overall to complete quality control of finished products.
Quality control of raw materials and finished products at JSC «Sintez» is carried out in laboratories of Quality Control Department: chemical, pharmaceutical, microbiological certified by Federal Supervisory Agency for Health Care and Social Development in 2008.
Company employees, that more than 3,000 people, are one of the key elements of Quality Assurance System and philosophy of GMP. They are regularly trained improving their proficiency and operating skills with modern technological equipment at State Research Center of Antibiotics, Pharmaceutical Training Center at Peoples’ Friendship University, St. Petersburg State Chemical-Pharmaceutical Academy, Moscow I.M. Sechenov’s Medical Academy, All-Russian Research Institute for Standardization. There is also an internal training at Technology School of Enterprise.
The scientific research on creation of new dosage forms also takes place alongside with production.
Core research laboratory of JSC «Sintez» is a scientific center capable to develop technologies for antibiotic substances and finished dosage forms, register and protect intellectual property, to introduce its projects into production. A skilled staff, including those with Degree level, complete tasks independently and in close collaboration with leading Research Studies Institute in Russia.
Sanitary lab of JSC «Sintez» has been accredited by Federal Technical Regulation and Metrology Agency to be in line with GOST R ISO/IEC 17025 for technical competence.
Acquired theoretical and practical skills are used by specialists in measurement procedure development of new projects of Manufacturer's monograph and revision of functional Manufacturer's monograph and substitution of outdate analysis procedure for modern one with higher accuracy and reproducibility that is of paramount priority in drug quality control.
JSC «Sintez» pays great attention to the issues of ecology and allocates significant funds for environmental safety.
Environmental management system of Enterprise has been certified by European TÜV NORD to comply with ISO 14001. The certificate validity is confirmed by annual supervisory audit of certified body TUV NORD.
Dynamically developing, implementing new technology, the plant increases overall production, while remaining a reliable partner on the market of medical products in Russia, far and near abroad.
