B-PHARM's production facility complies with international rules of drug manufacturing practice (GMP)

High-tech equipment of B-PHARM’ factory is capable of producing sterile dosage forms:

  • Injection solutions
  • Lyophilisates
  • Concentrates

Factory location:

Russia, Kaluga region, Borovsky Municipal District, Vorsino Rural Settlement, Dobrino village, 1st Eastern Passage 4 build. 1

Production capacity:

Capacity of production lines

20 millions

units per year

Total area

21 400 m 2

Production facility area

3500 m 2
The construction of the B-PHARM factory for the production of injectable dosage forms began in 2019. In three years the factory was built in accordance with the international GMP standard
Modern technologies and equipment use, as well as implementation of all production processes in accordance with the requirements of good manufacturing practices, allows production of quality drugs demanded in the hospital and commercial markets in Russia and other countries
B-PHARM has its own laboratory, which performs quality control of raw materials, as well as testing of drugs at all stages of the production process until the introduction into civil circulation, as well as continuous monitoring of drug quality throughout the shelf life

Main production lines

Production lines

The production building includes:

  1. Production area for vial medications
  2. Production area for ampoule medications
  3. Physicochemical laboratory
  4. Administrative block with technical rooms
Production lines
Production lines

Physicochemical laboratory

Modern laboratory allows to carry out full control of manufactured products

Equipping the analytical laboratory allows quality control of raw materials and control of final products by modern methods of analysis:

  • High performance liquid chromatography
  • Gas chromatography
  • IR spectrometry
  • UV spectrometry
  • Ionometry
  • TLC - thin layer chromatography
  • Electrophoresis
  • Amino acid analysis

Pharmaceutical quality system

The company operates a pharmaceutical quality system in accordance with the requirements of regulatory documents:

Rules of Good Manufacturing Practice of the Eurasian Economic Union (approved by Decision No. 77 of the Council of the Eurasian Economic Commission of 03.11.2016)

The Pharmaceutical Quality System (PQS) is a set of measures to ensure the effectiveness and safety of pharmaceutical products and their compliance with official requirements for quality indicators.

The system is aimed at ensuring and constantly maintaining an appropriate level of product quality, compliance with quality standards in the areas of: quality assurance and control, production, packaging and labeling, storage, logistics, business processes of the company.

The established quality management system is constantly being developed and improved.

  • Compliance of medicines production with GMP requirements is confirmed by the conclusion of the Ministry of Industry and Trade of the Russian Federation

  • Compliance with the rules of the Eurasian Economic Union on good manufacturing practices

Main documents on the functioning of the B-PHARM pharmaceutical quality system:

  • Quality Policy
  • Qualification/qualification policy
  • Policy on qualification, approval and maintenance of supplier/manufacturer status
  • Employee training policy
  • Company standards
  • Pharmaceutical quality system procedures

Qualification and validation

Validation master file:

  • Validation of the technological process and auxiliary processes
  • Facilities qualification
  • Equipment qualification
  • Cleaning validation
  • Engineering systems qualification
  • Validation of aseptic bottling
  • Risk analysis
  • Validation of computerized work systems and execution of validation documentation