Galenika Fitofarmacija | Management Systems

Management Systems

Galenika - Fitofarmacija a.d. applies the latest technologies and standards in every aspect of business, and in order to realize the defined objectives and enable efficient risk management in its business activities. Integration of various management systems makes business system flexible and ready to meet the requests of all interested parties and dynamic conditions of the environment, at every moment.

Quality Management System

Galenika - Fitofarmacija a.d., since 2005, has had certified Quality Management System, in conformity with the requirements of ISO 9001:2015 standard (initially ISO 9001:2000). Certification was carried out by Certification Company SGS, Belgrade.

The system was designed so to provide necessary and controlled quality level in all stages of product life cycle, from development, purchase of material, through formulation and packing, to storing and delivery. Correctly established processes and their interrelations represent the base for further development at all levels, in conformity with modern management concept.

The base for the establishment of the Quality Management System represents the Quality Policy, adopted by the Top Management.

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Management System in the Laboratory for physico-chemical testing

Function of the quality control is executed by the Laboratory for physico-chemical testing that was, in 2008, accredited in accordance with the requirements of ISO/IEC 17025:2017 (initially ISO/IEC 17025:2006) standard, by the Accreditation Body of Serbia.

Modern equipment, controlled conditions, skilled and trained staff in the laboratory guarantee independence, competence and high-level physical and chemical testing of technical substances and finished pesticide preparations, as for the internal so for the external clients.

Meeting of requirements of the aforesaid standard was executed with the purpose of the official recognition of competence, which means that the laboratory is able to offer correct and accurate testing results, they have competent staff, they use validated testing methods and appropr

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GLP (Good Laboratory Practice)

In addition to carrying out quality control, the Laboratory of Physico-Chemical Testing also has a certificate for the implementation of GLP testing for the purpose of product registration, in accordance with Good Laboratory Practice. The certificate was obtained in 2016 by the foreign accreditation body. As a first GLP laboratory for testing of pesticides in our country, the laboratory is capable to carry out testing of technical materials through 5-batch analysis.

Over sixty years of experience in the pesticide industry, competent staff, modern equipment, laboratory business oriented to the client, guarantees high quality of service at favorable conditions.

Beside the certificate, a verification of competence for implementation of GLP tests are also the GLP studies that we have already realized, for domestic and foreign sponsors as well. Our laboratory reports have been submitted to the EU regulatory bodies in the process of registration of plant protection products.

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Environmental Management System

Environmental concern of Galenka - Fitofarmacija a.d. by far exceeds only mere respect of regulations; it represents the reflection of high-level awareness of the need to actively work on improvement of that segment. The Top Management of the company confirms their commitment through adopted the Environmental Policy and certified Environmental Management System in conformity with the requirements of ISO 14001:2015 standard. The system was certified in January 2012, by the Certification Company SGS.

Production of plant protection products, which, due to its characteristics, represent certain risk for people and the environment, affects various aspects of the environment. Because of that, Galenika - Fitofarmacija a.d. executed identification and evaluation of the environmental aspects in relation to processes and activities they practice, and in order to establish which aspects have or can have significant influence on the environment.

In conformity with that, we carry out appropriate measures and procedures regarding control of aspects and reduction of risks, as much as it is possible. Aspects which prove to have significant influence on the environment, and which Galenika - Fitofarmacija a.d. can influence, represent priorities defining the directions of performance, establishment of general and specific objectives and programs for their realization, as a part of cycle of prevention of pollution and continual improvement of relation towards the environment.

In conformity with the status of Seveso plant of a higher rank and according legislation, Galenika - Fitofarmacija a.d. created the documents: The Report on Safety and Accident Protection Plan. The aforesaid documents contain risk assessment, prevention measures and measures of chemical accident prevention, as well as the order of the activities in case of accident and make-up of teams that are involved in response to accidents.

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Safety Management System

In accordance with the Rulebook on the List of hazardous substances and their quantities and criteria for determining the kind of document which make Seveso operator, or complex, Galenika Fitofarmacija a.d. is the Seveso higher-tier operator. Accordingly, in Galenika Fitofarmacija a.d. is established Safety management System - SMS.

Besides that, the following documents are prepared: Safety Report and Emergency Plan. These documents contain risk assessment, prevention measures and measures of protection against chemical accidents. Also, composition of the teams participating in the response to the accident, as well as procedure in response to the accident for different scenarios is defined.

In January 2014, Galenika Fitofarmacija a.d. received a decision on approval of the Safety Report and Emergency Plan, as two key documents for the Seveso operator, by the Ministry of Agriculture and Environmental Protection. Galenika Fitofarmacija a.d. is the first company that has received the approval of the competent authorities on the relevant documentation.

During the 2014 there was created a brochure to inform the public (households and companies in the environment) in relation to the Seveso operater, entitled "The importance of prevention and proper treatment to protect against chemical accident".

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EMAS (Eco Management and Audit Scheme)

Galenika Fitofarmacija a.d. was participated in 2014 in the project "Law enforcement in the field of industrial pollution control, prevention of chemical accidents and establishing the EMAS system", which is funded by the EU. The project was conducted in organisation of Ministry of agriculture and environmental protection, and in cooperation with the Ministry of environmental protection in Austria. Goal of the project was established system in accordance with the EMAS EU Regulation 1221/2009 in tree selected companies from Serbia (TRS Novi Sad, Gorenje Valjevo and Galenika Fitofarmacija a.d.)

In this way Galenika Fitofarmacija a.d. upgraded the existing environmental management system, primarily through the identification of indirect aspects, defining environmental performance indicators, as well as concrete improvements in energy efficiency.

Detailed information about EMAS can be found on the EMAS website

Occupational Health and Safety Management System

Employees represent the most important asset of the company, so the occupational health and safety Protection represents extremely important segment of the responsible business. According to the company profile the occupational health and safety management system was certified in January 2014 by the certification company SGS, Belgrade.

This system is based on the identification of risks related to occupational safety and health, as well as the implementation of measures to eliminate or reduce the risk to employees and other interested parties who may be exposed to the above risks.

Occupational Health and Safety Policy was adopted and expresses commitment of the top management to improve OH&S (Occupational Health and Safety) performance through: fulfil the requirements of standard ISO 45001 (initially OHSAS 18001), compliance with legislation, consultation and participation of workers, training and commitment to the prevention of injuries at work and occupational illnesses.

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