International Production Quality Standards
We are intensively developing, progressive company, and that is why the production quality issues are crucial for us.
Our production capacities located in the City of Zelenograd are organized in conformance with the current GMP standards and rules, GOST Р52249-2004 «Medical Aid Production and Quality Control Rules», SP 3.3.2.1288-03 «Good Manufacturing Practices for Medical Immunity and Biological Preparations» and the Construction Code 11-01-95 «Guidelines for Procedures of Development, Coordination, Approval, and Structure of Design Documentation, for Construction of Plants, Buildings and Installations». The lay-out design of production premises provides for appropriate protection of materials and products from contamination and, thus, meets the GMP requirements for premises in accordance with Chapter 3 of GMP EU Guidelines, and instructions of ISO EN 14644 - Clean rooms and associated controlled environments. With organization of production, there are taken into account the GMP requirements imposed on pharmaceutical production, which provide for: end-to-end processes with minimal distances between workshops, grouping premises with the same class of cleanliness, efficient deployment of equipment and materials to prevent from mixing up different types and series, materials, semi-products and off-the-shelf products, and personnel routing. All officinal articles are compiled with consideration of all requirements of the British pharmacopoeia without exception.
«Binnopharm» CJSC has the biggest GMP capacities in the Russian Federation (the only GMP production of 10ml vials in the Russian Federation, and the only industrial production site in the Russian Federation for aerosols and sprays without freons).
Special status in our products line is rendered to a sector of biotechnological preparations, which is the unique full-cycle industrial biotechnological production in Russia, with the most integrated and equipped laboratory for biotechnological preparation quality control, and the only such laboratory in the Russian Federation.
