Product Quality

Products of Sintez OJSC are high-quality, effective and safe medicines and medical products manufactured using modern equipment according to the international quality requirements.

Sintez OJSC has a statement of conformity of a pharmaceutical manufacturer to the requirements of the "Good Manufacturing Practice standards for medicinal products" under No. GMP-0061-000074/15 issued under order No. 2754 of the Ministry of Industry and Trade of the Russian Federation on September 14, 2015.    

The enterprise operates and continuously improves:
Industrial quality management system in the manufacture of medical products in accordance with the requirements of GOST ISO 13485-2011 (ISO 13485:2003)
Quality management system (QMS) in accordance with the requirements of GOST R ISO 9001-2015 (ISO 9001:2015)
Environmental management system (EMS) in accordance with GOST R ISO 14001-2016 (ISO 14001:2015).
Inspection visits during supervisory and certification audits are annually held to confirm the validity of the MS certificates of conformity.

Quality Control Department

The main function of the Quality Control Department is to carry out incoming control, in-process control and quality control of finished products in accordance with requirements of specifications and regulatory documents (RD).

The purpose of quality control is to prevent the use or sale of materials or products that do not meet quality requirements. Quality control is intended to prevent the release of medicines that do not meet RD requirements, delivery terms and contracts or to prevent deficient products, as well as to strengthen industrial discipline and increase responsibility for product quality at all levels of production.

All quality control specialists have special education, required expertise, qualification and experience. 

The Authorized Persons that release medicines into civil circulation are appointed in the enterprise by the respective order in accordance with Federal Law No. 61 from April 12, 2010, "On circulation of medicines", international requirements and Good Manufacturing Practices. The most important duty of the Authorized Person is to certify that each batch of the finished product released for sales meets the requirements set out upon their state registration, and guarantee that medicines are manufactured in accordance with GMP regulations.

Sintez OJSC Quality Control Department comprises:

  • 3 quality control laboratories

    • Chemical Laboratory

      Carries out quality control of raw materials, production process of finished dosage forms, substances and medical products, and finished products. The laboratory is fitted out with modern equipment. Special attention is given to the incoming control of sterile and non-sterile substances where each piece in the series is authenticated.

    • Pharmacological laboratory

      Carries out biological control of pharmaceutical substances, finished dosage forms, polymeric raw materials and medical products made of them. Biosafety control for medicines is carried out for the basic complex toxicity: through tests for pyrogenicity, abnormal toxicity, content of depressors, bacterial endotoxins, quantitative assay of bioactive oxytocin. The modern instrumental methods of control (in vitro) are widely used along with traditional experimental methods using laboratory animals (in vivo). .

    • Microbiological laboratory

      Carries out incoming control of substances, raw materials, adjuvants and supplies, finished product control based on Microbiological Purity or Sterility tests, as well as microbiological monitoring in the production. Membrane filtration sterility testing is carried out using both the filtration apparatus (open method) and the device that almost completely eliminates the possibility of false results. The microbiological laboratory also performs analysis of antimicrobial activity of antibiotics, has a license from the Federal Service and a Sanitary and Epidemiological Conclusion of the Chief Sanitary Physician for the city of Kurgan to carry out activities related to the use of microorganisms in Pathogenicity Group 4.

    The laboratories of the Quality Control Department are furnished with necessary measuring, auxiliary and testing equipment ensuring accuracy of results. They also have a sufficient quantity of consumables, chemicals, chemical ware, standard samples, nutrients, experimental animals.

    The laboratories have all standard documentation, external and internal, to carry out quality control, and all documents to record quality control results (log books, analytical reports, datasheets, sampling protocols, etc.).

  • 3 control teams:

    • for incoming control of raw materials and supplies
    • for in-process control of medicines
    • for production control of medical products and printing products.