Policy of Quality
FSUE "Moscow Endocrine Plant" is an enterprise of high culture of production. The quality system is maintained throughout the life cycle of the product: from the stage medicinal products development to the stage of their realization to the end-user.
The Company was one of the first in Russia to introduce international standards of production and quality control - "Good Manufacturing Practice" (GMP). In 2018, the conclusions of the Ministry of Industry and Trade of the Russian Federation on the compliance of the manufacturer of medicines for medical use with the requirements of the Rules of Good Manufacturing Practice No. GMP-0050-000302/18 and No. GMP-0050-000303/18 were reconfirmed.
The Enterprise recieved the International Certificate of GMP Compliance of the European Union from the European GMP Directorate for production line for sterile medicines in injection form No. ZVA/LV/2019/002H of 04.02.2019. This Certificate is recognized in the countries of the European Union and the USA, as well as in the countries of Asia, Africa, etc., and proves that the production, control, storage and other procedures at the Enterprise meet the international requirements of GMP. Obtaining this certificate opens up opportunities for foreign registration of the Enterprise 's products for export purposes.
All equipment, engineering systems, clean rooms and storage areas used in the production of finished dosage forms have the status "qualified." Production and process processes are regularly validated.
The pharmaceutical quality system of the Enterprise is certified in the system of voluntary certification of management systems for compliance with GOST R 52249-2009 registration number No. OSM RU.04-С21-127.
The Quality Control Department is accredited as a testing laboratory in the Federal Service of the Accreditation according to the standard GOST ISO/IEC 17025 (accreditation certificate number RU.RA.21Н019 dated 22.01.19).
The test laboratory of FSUE "Moscow Endocrine Plant" includes chemical and microbiological laboratories and a modern vivarium.
The accreditation service includes 116 types of tests allowing carrying out quality control of finished dosage forms (including biological medicinal products), veterinary preparations, active pharmaceutical ingredients and auxiliary substances, as well as microbiological monitoring of the production environment.
Qualification of employees and equipment of laboratories guarantee accurate and correct results and ensure compliance of the carried out research with modern requirements of the Russian and international standards.
The work of the departments of the Enterprise is aimed at maintaining and improving the functioning of the pharmaceutical quality system, which ensures constant reproduction of standard production processes and, as a result, the production of high-quality medicines.
We cherish the quality of our products and work for people, for the benefit of their health. Our principles are permanent for more than eight decades - building on the latest advances in science, to be always on top of quality for the good of the nation's health.