ДНДКІ ветеринарних препаратів та кормових добавок

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Department of state control, standardization and certification Print

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Tesarivska Ylyana Ivanivna

Head of the Department - Candidate of Veterinary Science.

Phone: (032)-252-21-50; 231-63-50

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Veluchko Volodumur Olexandrovuch

Head of Test Centre (TC) accredited in accordance the requirements of SSTU ISO/IEC 17025, Chief Scientist - Doctor of Veterinary Science, Professor, Academician of International Personnel Academy.

Phone: (032)-252-21-50; 231-63-50

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HISTORY OF THE DEPARTMENT

FUNCTIONS OF THE DEPARTMENT:

- state supervision and control over compliance with the standards and specifications by the manufacturer in the production for veterinary medicine;

- the selective quality control of veterinary medicinal products, feed, feed additives and premixes;

- inspection of veterinary medicine enterprises for their licensing;

- standardization of veterinary medicinal products, feed. feed additives and premixes;

- carring out of work on certification of enterprises and accreditation of laboratories of veterinary medicine;

- sertification of veterinary medicinal products, feed, feed additives and premixes, raw materials and animal origin products, quality systems;

- training veterinary medicine supervisors for manufactures of veterinary medicinal products, feed, feed additives and premixes;

- brining to conformity normative documents for national veterinary medicinal products, feed, feed additives and premixes with the applicable standards;

- complectation of technical standards fund;

- scientific research on standardization, certification, quality of veterinary medicinal products, feed, feed additives and premixes;

- standardization of quality control methods of veterinary medicine products, development of new normative documents (regulations);

- harmonization with international of national standards for veterinary products;

- scientific, methodological and advisory activity on the issues of development new veterinary preparations, feed, feed additives and premixes;

- summarizing of scientific research, preparing and publication of scientific articles, guidelines;

- organization of implementation of completed scientific research (provisions, instructions, standards, regulations, guidelines, etc.) in manufacturing process.

The personnel of the department in addition to the expert and control work initiated for the first time in Ukraine the development of needed normative documentation (regulation) on certification of veterinary medicine production, such as veterinary medicinal products, feed, feed additives and the means of veterinary medicine, which on the established procedure adopted at national level. Regulations on certification of veterinary medicine products are adapted to the international, allowing certification of products, both domestic and foreign manufacturers. For example: from 1998 more than 400 veterinary medicinal products, 750 feed additives were certificated, moreover 40 percent of products were certified directly in manufacturing with their inspection.

In the work of the department were established the procedures of accreditation of veterinary medicine laboratories, which are on enterprises, as well as the certification of productions. The relevant regulations were developed and approved on these issues. Experience of the department co-workers allows to develop proposals for the laws of Ukraine and relevant government documents. On the state level were developed and adopted 98 regulations, as well as a comlex system of quality control for veterinary medicine products.

During the period of functioning of the department were trained and certified 229controllers for veterinary medicine enterprises, carried out 23 workshops and 4 scientific conferences.

System of state control and supervision at which the department works and in general SCIVP of veterinary medicinal products and feed additives includes:\

– expertise of regulations on veterinary preparation and feed additives with previous testing of products samples;

– selective quality control of products and compliance with conditions to produce, store and sell these products for veterinary medicine and animal husbandry;

– inspection of enterprises in compliance with conditions to produce, store and sell the veterinary medicine products;

– implementation of veterinary and sanitary control and supervision in all steps from the development to sale of products;

– standardization and certification of veterinary medicinal products for compliance and safety;

– analysis of technology and technical regulations compliance;

– inventory of normative documents according their actuality and completeness on enterprises, producing veterinary medicine products (registration dossiers, technical regulations, quality control methods, regulatory documents on requirements for the enterprises functioning);

– carrying out pre-registration inspections of enterprises on compliance manufacturing conditions for production qualified and safety veterinary medicinal products, feed and feed additives. Results attach to the materials, which are provided by enterprises to the registration dossier;

– carring out the activities with distributive and pharmacy practices enterprises on prevention circulation of substandard, counterfeit, adulterated and non authorization veterinary medicinal products, feed and feed additives.

During the period of functioning of the department prepared and issued: 7 monographs, 27 guidelines, 34 standards, reference book for doctor of veterinary medicine, vocabulary of terms and symbols, used in veterinary medicine, published 196 articles, received 5 patents. During the period 1992 - 2014 2456 technical requirements concerning veterinary medicinal products, feed, feed additives, premixes and veterinary medicine means were brought into conformity, approved and handed to developers and manufacturers. These allowed increasing the assortment of products to 700 units and bring provision of domestic products to almost 70 per cent (on the moment of Soviet Union collapse the availability of products was 17 per cent).

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