(8362) 42-03-12
marbiofarm map
Republic of Mari El, Yoshkar-Ola city, K.Marksa street, 121
marbiopharm@marbiopharm.ru
Company

Quality control

The high quality of the «Marbiopharm» is noted by various awards.

The production of the enterprise had become a winner of such competitions as:

  • «100 best goods of Russia»

  • «The best goods of the Mari El republic».

The quality control service is presented on “Marbiopharm”. It includes two divisions, which are responsible to the Quality Director – Quality control division and Quality procuring division.

Quality control division has a lot of production space, is equipped with all the necessary modern laboratory equipment and measurement tools, standard samples and reagents.

Quality control division includes control and analytical and microbiological laboratories, verified by the Federal Service on Surveillance in Healthcare and Social Development (technical competence certificate № КК- 0010–06 от 25.05.2006). QCD has a License issued by the Federal Service on Surveillance in Consumer Rights Protection and Human Welfare №12.РЦ.02.001.Л.000024.08.06 от 15.08.2006 for the activity bound up with the using of the infectious agents of the pathogenicity groups III and IV. The License is valid until 16.08.2016.

Quality control division functions:

  • The input quality control of raw materials

  • Interoperational production control

  • Quality control of the finished products

  • Work with the archive samples

  • Work on complaints and claims

  • Preparation and registration of the documents for the enactment of the conformity of the finished products Declarations.

Quality procuring division does research on designing и improving of the management quality System, on implementation and control of the production rules compliance and on the control of the quality of the medicines (GMP).

Quality procuring division functions:

  • Management of documentation and records

  • Personnel’s training

  • The organization of the inner audits (self-inspections)

  • The organization of the validation works

  • Annual products’ quality review

  • QMS functional analysis.

Quality Management System is functioning on “Marbiopharm”. It includes manufacturing and quality control organization according to GMP (Good Manufacturing Practice).

Obligations on quality and customer satisfaction are defined in the Quality policy.

QMS includes a complex of events, the implementation of which guarantees the release of release of high-quality, effective and safe products.

On «Marbiopharm» there are also Document Management System, Personnel Training System, Inner Audits (self-inspections) System, Nonconforming Product Management System, Corrective and preventive actions System.

QMS has been successfully certified by the QMS certification agency of the “Russian Register” certificate association for the compliance with the requirements of the ГОСТ ISO 9001-2011 (certificate of Compliance reg. № РОСС RU.ИС08.К01769 от 27.03.2013).