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Quality System

Integrated Pharmaceutical Quality System (IPQS) is implemented at the plant. It combines the requirements of the following standards:

  • GMP (Good Manufacturing Practice),
  • GDP (Good Distribution Practice),
  • GSP (Good Storage Practice),
  • G (Q) СLP (Good Quality Control Laboratory Practice),
  • ISO 9001 (quality management system),
  • ISO 14001 (Environmental Management System),
  • ISO 17025 (General requirements to the competence of testing and calibration laboratories),
  • ISO 50001 (Energy Management System),
  • OHSAS 18001 (Occupational Health and Safety Management System),
  • Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs including the HACCP principles (Hazard Analysis and Critical Control Points)
  • and considers the elements of
    IMPAC 10000 (management system, aimed at improved business performance and reduced expenses of resources).