Quality control

Quality and safety management system of our Company is built on the requirements of GMP, ISO, ICH, and a number of other Russian and international standards

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Our quality and safety management system is based on the requirements of the Russian and international standards — GMP, ISO, ICH, and the like:

Our manufacturing operation regularly undergoes scheduled external audits, client audits, and internal audits.

Our safety management system has been audited and found to be in compliance with the ISO 22000:2005 international standard (Certificate 18.0196.026 of August 21, 2018).

Our company has received Certificate No. GMP-0065-000310/18 verifying the compliance of this manufacturer of medicinal products with the Good Manufacturing Practices regulations.

The quality of our products is ensured by the proper organization of the entire manufacturing process, from materials procurement to selling our products to customers in accordance with the requirements of international standards. In an effort to ensure the quality and safety of our products we have adopted a multifaceted approach to quality control, since it is impossible to maintain the high quality of our products simply by means of full control over the final product and through weeding out the defective items.

  • 12 external audits in 2017
  • Development of own analytical methods
  • More than 20 000 analyses at the end of 2017

We purchase raw materials of verified quality from approved manufacturers and suppliers only.

Our suppliers are listed in the «Our Partners» section.

We control the raw materials up until they are used in the manufacturing process.

The manufacturing process is organized in full compliance with the standards.

We control the final product in accordance with technical rules and regulations.

In order to ensure the quality of the raw materials, that of materials used at the intermediate stages of production, and that of the final product, we use our own analytical laboratory accredited by the Federal Agency on Technical Regulating and Metrology (the accreditation certificate of a testing laboratory No. РОСС.RU.0001.22ФЛ03 of June 14, 2011). The laboratory employs the following methods of research and analysis: high-performance liquid chromatography, spectroscopy, atomic absorption spectrophotometry, infrared spectrometry, voltammetry, titrimetry, polarimetry, enzyme immunoassay, thin-layer chromatography, and so forth.

Our personnel is highly qualified.

All employees of Vneshtorg Pharma have the necessary level of expertise, have experience of working in the industry-leading Russian companies, and improve their qualifications on a regular basis.

Up-to-date, high-tech equipment.

Our manufacturing facilities are outfitted with high-tech equipment from well-known and reliable manufacturers. Every piece of equipment is outfitted with various high-precision sensors that allow us to have absolute control over our products during their production and packaging.

We maintain the required manufacturing conditions as well as storage conditions in all areas.

In all production areas, the required temperature and humidity conditions are rigidly maintained, the incoming air is properly purified, and other parameters, such as may influence the technological processes and the quality and purity of the final product, are closely monitored.

We maintain the proper storage and transportation conditions in order to preserve the qualities of our products.

In our storage facilities, we maintain the climate conditions required for the storage of raw materials and products. The storage facilities are divided into the following areas: the general storage area, the special storage area (cool and cold storage areas); raw materials and products are also protected during all loading and unloading operations. The products are transported by the licensed freight companies and are protected from weather conditions during transportation, for the entirety of which the temperature conditions are being monitored as well.

We gather customer feedback and strive to cater to the needs and demands of our customers.

We examine and analyze all submissions from our customers, and our experts provide competent answers to our customers’ questions.