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 - phytopreparations. It is the only 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 compromises production under controlled conditions, obligatory controlling, documenting and material proving of the whole systems. In addition, it includes stricter supervision and work with subcontractors, more rigorous control starting materials, validation of production procedures and production conditions, validation of the 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 filed, 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 plants and phytopreparations, as an important segment of AD "Zdravlje" Quality System.

The aim of the quality planning in the manufacture of the products of plant origin is as follows:

• meeting the requirements of the series of the standards JUS ISO 9000, GMP and GLP regulations in the pharmaceutical production, legal regulations and technical standards;

• meeting the purchasers' requirements for the quality and making the profit.

Out of all business activities covered by the quality loop, the production:

• confirmation of the ability of the process to manufacture the products which are quite in compliance with the specified requirement or with the purchaser's requirements (the process validation),

• defined requirement for the quality of the input material, semi-finished product and the finished product (the compliance with the standards of the products and with the legal regulations),

• approval of the initiation of the process according to the defined criteria,

• it is carried on according to plan (according to the procedures, instructions and production procedures).

There have been defined the procedures of work with the exact sequence and description of the activities, executor, the equipment, the material, the quality, the records and the evidences:

• maintenance and control over the production area,

• it is carried on by skilled and expert personnel,

• identification and complete traceability,

• defined procedures in non-compliance and taking the corrective and preventive measures,

• corresponding way of packing and handling.

The quality is not controlled in the product but it is built in it from the very beginning. Therefore, all the activities in the quality loop, from the development of the new product, through the purchase of the material, fproduction process and up to the delivery to the end-user, are covered by the procedures of controlling and testing. Both the controlling and testing in the course of the production process are carried on according to the Plan for controlling.

The Plan of controlling consists of:

a) The Diagram of the course of the production process with the control points,
b) The Table of control activities and
c) The list of products subject to the Plan for controlling.

UK-the input control, AK-the autocontrol, PK-the in-process control, LK-the laboratory control and ZK-the output control.

The aim of Quality Control of medicinal plants and products as the segment of Quality System of AD "Zdravlje" is to define of the testing parameters, the acceptable quality level and frequency of controlling.

For each control point there has been defined the following:

• Testing parameters and the acceptable quality level,

• Executor of the control activities and the responsibility for verification,

• Procedure, instruction or the regulation for testing (on the basis of which is carried out the sampling, controlling and testing),

• Frequency of controlling,

• Control and measurement equipment,

• Records of the results of controlling (Certificate of analysis, File on the quality of the batch) serve as a proof that the product has been controlled and tested according to the established criteria and that it has been in compliance with the requirements,

• Designation of the status of the quality of the product in the appropriate way, pointing to the compliance or deviation from the specified requirements,

• Conveyance of the information on the quality,

• Procedure in non-compliance and taking the corrective measures.

Through the application of this Quality system we achieved the carrying on of the production process under controlled conditions, providing the high and standard quality of the products, leading us to the aim of the "zero-defect", what is a condition for providing the survival and competitive advantages on the market.

1. Standardi serije JUS ISO 9000, 1997.

2. Heleta M. et al. (1995): Plan kvaliteta u funkciji obezbeđenja kvaliteta, II Naučno-stručni skup, Divčibare.

3. Commission of the European Community: Good Manufacturing Practice for medicinal products in the European Community, 1998.

4. Leskošek-Čukalović I. (1997): Kontrola u proizvodnji eko-hrane, Ekotehnologija u prehrambenoj industriji i biotehnologiji, Beograd, 119-128.