Quality systems

Pharmaceutical Quality System has been developed and implemented at Valartin Pharma. The effectiveness of Quality System functioning is determined by fulfillment of the requirements of Licensing conditions of manufacturing and wholesale trade of Medicinal products.

Full quality control is performed at all stages of manufacturing process starting from incoming control of raw materials and to final control of finished product:

• incoming quality control of raw materials;
• quality control of intermediates (precursors) during the production process;
• quality control of finished products (medicines and dietary supplements);
• confirmation of equipment cleaning (control of residual amounts of the key active ingredients and detergents);
• finished product stability study during the whole shelf live period;
• microbiological monitoring of the production site and process;
• constant monitoring of purified and drinking water;
• quality control methods transfer at the stage of pharmaceutical development of new products;
• analytical/microbiological support for the validation of production processes.

Maintaining the effective functioning of the pharmaceutical quality system in the company is performed by the Department of quality management.

The structure of the Department includes the Quality Assurance Department (QA), Department of Quality Control (QC) and the Department of validation (VD).

The physical chemistry laboratory of QA department of the company is certified by State Administration of Ukraine on Medicinal Products (Certificate of Attestation   №403 of 19.04.2019).

In its activities, Valartin Pharma LLC is guided by the requirements of the Licensing conditions of manufacturing and wholesale trade of drugs businesses, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), Good Storage Practices, ISO, as well as the requirements of Regulation of the European Parliament and of the Council number 852/2004 of 29.04.2004 on the hygiene of foodstuffs as their guidelines.

The quality management system of "Valartin Pharma" LLC regarding the development, production and sale of medicinal products and dietary supplements is developed, implemented and maintained in accordance with the requirements of ISO 9001:2015 "Quality management systems - Requirements" and DSTU ISO 9001:2015 "Quality management systems. Requirements".