Quality control – Marbiopharm
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 №12.РЦ.02.001.Л.000024.08.06 ot 15.08.2006г..
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
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.