[P-058]
QUALITY CONTROL OF MEDICINAL PLANTS AND PRODUCTS AS THE SEGMENT OF QUALITY SYSTEM OF "ZDRAVLJE"

Zoran Stojanović1, Branislav Gudžić1 and Siniša Đorđević2
1AD"Zdravlje"- Quality Control Sector, 16000 Leskovac, FR Yugoslavia
2Faculty of Chemical Engineering, 16000 Leskovac, FR Yugoslavia

During last years, significant and characteristic change in the field of the quality of medicinal plants and products is turning of Quality Control into Quality Assurance, by application of quality standards JUS ISO 9000 and Good Manufacturing Practice.

Quality Control was mostly oriented to the testing of medicinal plants and final products-phytofarmacs. It is only the way of identification of the products, which are not in accordance with specified requirements, before, during and at the end of the production process. Quality Assurance comprises production under controlled conditions, obligatory controlling, documenting and material proving of the whole system. In addition, it includes stricter supervision and work with cooperants, more rigorous control starting materials, validation of production procedures and production conditions, validation of control procedures, planned controlling according to the specified requirements, testing of final product stability, defining the storage conditions and use, monitoring of quality during expiry date and etc. All this in practice means enormous investments into complete production and control, in order to satisfy strict regulations, but at the same time it is a condition for survival on the market.

AD "Zdravlje", from its founding until today, uses medicinal plants for production. Great experience has been gained in this field, from growing, selection and production of medicinal plants, production of extracts and pure substances, to the production of phytopreparations.

The aim of this paper is to present the Quality Control of medicinal plats and phytopreparations, as an important segment of AD "Zdravlje" Quality System.

[Full paper: P-058]
[P-058]