Quality systems

VALARTIN PHARMA LLC has developed and implemented a pharmaceutical quality system, the effectiveness of which is subject to annual analysis by the Company's Management and the definition of further measures to improve its functioning.

The pharmaceutical quality system is aimed at organizing, determining measures, controlling and monitoring compliance with the requirements of the Licensing Conditions for conducting business activities in the production of medicinal products, wholesale and retail trade in medicinal products, import of medicinal products (except for active pharmaceutical ingredients), the requirements of Good GHP practices and ISO standards, as well as its continuous improvement.

The company's management has developed a Quality Policy and defined tasks to achieve the set goals. Responsibility for the proper functioning of the Company's FSS is assigned to the personnel of all business processes involved in the FSS. Coordination of the work of structural units for the proper functioning of the FSN is entrusted to the Quality Management Department, which includes the Quality Assurance Department, the Quality Control Department, and the Validation Department.

The physicochemical laboratory of the Quality Control Department is certified by the State Service of Ukraine for Medicinal Products (certificate of certification No. 403 dated April 19, 2019), which is equipped with modern laboratory equipment.

The enterprise carries out full quality control at all stages of production from raw materials to finished products:

  • conducting incoming control of raw materials and materials;
  • conducting quality control of intermediate products (semi-finished products) during the production process;
  • quality control of finished products (medicines and dietary supplements);
  • confirmation of equipment cleaning (control of residual quantities of main active ingredients and detergents);
  • studying the stability of finished products throughout the entire shelf life;
  • conducting microbiological monitoring of production;
  • continuous monitoring of purified water and drinking water;
  • transfer of quality control methods at the stage of pharmaceutical development of new products;
  • analytical support during validation of production processes.
  • outsourcing work (quality control of raw materials, materials and finished products under contract)
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