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GMP system implementation

We provide comprehensive services related to implementation of GMP system to pharmaceutical companies to obtain manufacturing/importation authorisation and GMP certificate. Based on mutual cooperation, we discuss, analyse and propose custom-tailored solutions, develop policies and procedures, conduct trainings  and internal audits.

When preparing and implementing the GMP system, we pay special attention to such an aspects as:

  • personnel: trainings, experience,
  • premises and equipment and its’ validation,
  • supportive systems: HVAC, water and other installations,
  • starting and packaging materials,
  • compliance of conducted processes with medicinal product dossier and other law regulations,
  • quality control laboratories,
  • outsourced activities, including suppliers qualification, subcontractors audits, API audits
  • complaints and recalls management,
  • internal audits performance,
  • system documentation and changes, deviations, OOS results management.

We ensure efficient and fast implementation of the company-specific GMP system.