Biocom
RusEng
THE FLEXIBLE MODULAR PHARMACEUTICAL MANUFACTURE CERTIFIED
FOR THE INTERNATIONAL QUALITY STANDARD GMP
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About us

Field of activity
 

Nowadays JSC Biocom is a modern flexible modular manufacture. In May 2005 the enterprise was certified by the German company "Pharmaplan GmbH" for conformity to international quality standard GMP in EU. In May 2007 JSC Biocom certified its quality management system according to requirements of the international standard ISO 9001:2000 and the International Certification Network IQNet. In 2008 JSC Biocom received certificate of its quality management system in accordance with requirements of the national standard ГOCT P 52249-2004 and ГOCT P ISO 9001:2001.

To provide an appropriate quality, the company works only with the leading European suppliers of active pharmaceutical ingredients, excipients and packaging materials.

Currently Biocom's strategy follows 2 main paths: production of branded equivalents (generics) due to the full cycle and contract manufacturing. The principle of technology’s fast change allows to pass on to another product very quickly, in 24 hours. Besides the complex production of pharmaceuticals JSC Biocom fulfills packaging, labeling and quality control of medicines at any stage of production according to the international quality standard GMP. JSC Biocom is open to the possibility of cooperation with all the players on the pharmaceutical market.
 

HISTORY
 

The enterprise JSC Biocom has been working on the market of immune and biological pharmaceuticals since 1991. In 2002-2004 the general renovation was done by the general contractor PSP Clean Air Ltd. in order to assure successful activity and development. At present the company specializes in production of solids due with the application of complete technological cycle. From 2007 our enterprise has been affiliated by the business group JSC Pharm-Center.
 

STRUCTURE


Aiming of the most challenging targets depends on the continuously perfected organization structure. In the result all the recourses and facilities now can be mobilized and distributed in the most efficient way. The management team has done their utmost to make current structure corresponding to the most severe strategy requirements.


QUALITY


High professionalism of Biocom’s expert personnel helps to assure product marketability and success. JSC Biocom is committed to protect the interests of its customers, employees and other community stakeholders. In 2005 JSC Biocom was certified by the German company Pharmaplan GmbH against the requirements of the international quality standard GMP in EU. The importance of introduction standards GMP cannot be overemphasized. This is the factor of high influence in creation and maintenance of the image of the leading company, which ensures operational release on the market of high-quality and safe inexpensive pharmaceuticals. GMP rules are the general guidance, which establishes the order of the organization of production process and control. They contain minimum practical instructions on the contemporary correct conducting of manufacturing. In order to provide the development of GMP rules in the different countries various documents and standards are created, which regulate and define concrete conditions of organization and conducting the production process of several pharmaceutical dosage forms. Key concept, utilized in the standards - "System of the quality management (control)" (SMQ). The special feature of standards is the fact that they impose requirements not for the quality of production directly, but for the system of the management organization in company, which is called to ensure the predictable and stable level of the production/of services quality.

In May 2007 JSC Biocom certified its quality management system against the requirements of the international standard ISO 9001:2000 and the International Certification Network IQNet. IQNet certificate allows receiving a certificate in any of 50th countries which are members of IQNet.

In 2008 JSC Biocom received certification of its quality management system in accordance with requirements of the national standard ГOCT P 52249-2004 and ГOCT P ISO 9001:2001.

Besides, JSC Biocom initiates various inspections by inviting auditors from foreign pharmaceutical companies who are the leaders of development and high-technology assurance of manufacruting.

August 20, 2013 JSC Biocom became the first Russian pharmaceutical manufacturers, approved as pre-qualified supplier by World Health Organization. Received approval for the supply - Cycloserine capsule 250 mg N 100.


As a consequence of the inspection by Ministry of Industry and Trade of Russian Federation that was held on 30.10.2015, JSC Biocom has received “The Certificate of conformance of the pharmaceutical manufacturer with Good Manufacturing Practice standards for medicinal products” № GMP-0078-000098/15 dated 17.12.2015 (GMP Certificate).

 
Fluconazole 50 mg
54 Chapaevsky Cr., Stavropol, 355016, Russian Federation
tel.: +7-8652-365356, fax: +7-8652-365355
E-mail: biocom@biocom.ru