Product Quality

Sintez OJSC manufactures high-quality, effective, and safe medicinal products and medical devices using modern equipment and in full compliance with international quality standards.

Sintez OJSC has the Statement on the compliance of the manufacturer of pharmaceutical products for medical use with the requirements of GMP Certificate No. GMP-0061-000372/19 was granted to Sintez OJSC on April 19, 2019 by the Ministry of Industry and Trade of the Russian Federation.

The following quality management system is implemented and being improved continuously in the company:
Quality Management System for Medical Device Manufacturing according to GOST ISO 13485-2017 (ISO 13485:2016).
The validity of Management System Certificates of Conformity is affirmed annually following inspection in the course of witness and certification audits.

Quality Control Department

The main function of the Quality Assurance Department is to carry out incoming control, in-process control, and finished product quality control in compliance with the requirements of specifications and regulatory documentation (RD).

The goal of quality assurance is to ensure that used or distributed materials or products meet quality requirements. Quality assurance prevents the release of incomplete products and MP non-compliance with the requirements of RD, contracts, and terms of delivery. Another quality assurance goal is to improve performance discipline and to increase the responsibility of all parts of the production chain for output quality.

All of our quality assurance specialists are qualified professionals with the required technical skills and expertise.

In accordance with Federal Law No. 61 “On Circulation of Medicines” dated April 12, 2010, international requirements and the requirements of Good Manufacturing Practices, the company has appointed Authorized Persons responsible for the civil circulation of medicinal products. The most important duty of the Authorized Person is to ensure that each batch of finished products released for sale meets the requirements established at the time of their state registration and those of GMP.

The Quality Assurance Department at Sintez OJSC comprises:

3 quality assurance labs:

    • Chemistry lab

Involved in quality assurance for raw materials, the production process for finished dosage forms, substances, medical devices and finished products. The lab is outfitted with state-of-the-art equipment. There is a special focus on incoming control for sterile and non-sterile substances and identifying the authenticity of each location in the batch.

    • Pharmacological lab

Carries out biological control of pharmaceutical ingredients, finished dosage forms, raw polymer materials and medical devices developed thereof. Biological safety control for medicinal products is carried out according to the main toxicological complex: testing for pyrogenicity, abnormal toxicity, depressors, bacterial endotoxins, identification of the quantitative level of the biological activity of oxytocin. Modern instrumental control methods (in vitro) are widely used in addition to traditional testing methods using laboratory animals (in vivo).

    • Microbiological lab

Carries out incoming control for substances, raw materials, auxiliary substances and materials, control of the finished product according to Microbiological Purity and Sterility tests, as well as microbiological monitoring during production. Sterility tests using the membrane method are carried out both with the use of a filtration unit (open method) and a device. This approach almost completely eliminates the possibility of false results. The microbiological lab also identifies the antimicrobial activity of antibiotics, and has a federal license and a sanitary and epidemiological conclusion issued by the Chief Sanitary Doctor of Kurgan for work involving the use of pathogenicity group 4 microorganisms.

The labs in the Quality Assurance Department are outfitted with all the necessary measuring and accessory equipment, as well as testing equipment to ensure the reliability of results. They also have all the required expendable materials, chemical reagents, chemical utensils, standard samples, nutrient media, and experimental animals.

The labs possess all the internal and external regulatory documentation for quality assurance procedures, as well as documents for registering the results of quality assurance (logs, analytical sheets, data sheets, sampling protocols, etc.).
  • 3 control groups:

    • input control of raw materials and supplies;

    • in-process control for drugs;

    • production control for medical devices and printing products.