+38 066 4165366

+38 066 4165366

GDP

It is important for the pharmaceutical industry to maintain the safety and quality of pharmaceutical products at all stages of its supply.

The introduction of Good Distribution Practice (GDP) standards ensures that the proper quality of medicines is maintained, from the receipt of raw materials to the delivery of GLS to the final consumer.

GDP

 Preparation of companies-distributors of medicines for certification and inspections for compliance with the requirements of good distribution practice (GDP) – diagnostic audit, expert advice, development and optimization of documentation (SOP, instructions, validation and other documentation).
 Information support and consultations of importers of medicines (practical assistance in the development of the necessary documentation: SOP, instructions, dossier of the importer, validation and other documentation).
 Conducting validation / qualification tests in warehouses (temperature mapping of the warehouse, qualification of the main technological equipment URS / FAT / SAT / DQ / IQ / PQ).
 Corporate training of your company’s staff on GDP.

GXP – YOUR AUTHORIZED REPRESENTATIVE IN UKRAINE

  • Medical devices classification
  • Conformity assessment support
  • Professional assistance in the process of placing on the market class I medical devices
  • Project support from development of medical devices to placing them on the market
  • Execution of technical documentation
  • Execution of a Declaration of conformity
  • Consulting services concerning labeling of medical devices
  • DSTU EN ISO 13485:2018 (development of QMS, implementation, certification support)
  • Custom-made medical devices (application submission to the State Service of Ukraine on Medicines and Drugs Control support)
  • Obtaining a permit from the State Service of Ukraine on Medicines and Drugs Control for realization of clinical investigations
  • Authorized representative for manufacturers non-residents of Ukraine

+38 066 4165366

ar@gxp.farm

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