Bulletin "Veterinary biotechnology"

  • Print

Veterynarna biotehnologija – Veterinary biotechnology, 2016, 29, 184-195 [in Ukrainian].

NAPNENKO O.O., e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

State Scientific Control Institute of Biotechnology and Strains of Microorganisms

THE HISTORY OF REFORMING OF THE VETERINARY IMMUNOBIOLOGICAL MEANS QUALITY CONTROL SYSTEM

Introduction. The leading place in the system of anti-epizootic measures takes timely prevention and diagnostics of infectious diseases, which is impossible without high-quality veterinary immune means. Today, producer is responsible for the quality control manufactured products. Quality control is a part of the work in accordance with the good manufacturing practices requirements. Formation of the quality control system of veterinary preparations dates back to the early twentieth century and eventually has been reformed.

The goal of the work. The purpose of this study was to analyze reforming of the veterinary immunological means (VIM) quality control system.

Materials and methods. The work performed by analysis of regulatory documents and publications of the scientific editions over the last century.

Results of the study and discussion. Centennial period of VIM production of the quality control system development in Ukraine conventionally can be divided into six periods: - Primitive – manufacturers collected information about the effectiveness, possible side effects and complications of means application; beginning of the XX century until 1911; - Selective – manufacturers began to control quality during production by “purity” indicators; country began intervene the quality control issues of certain preparations; 1911–1921; - Transitional – manufacturers paid more attention to the means’ harmlessness and effectiveness during production; lasted from 1921 to 1930; - State period began in 1931 with the establishment of control institute and the implementation of mandatory quality control of all means and subordination of the heads of biological control departments to the Control Institute; completed in 1975; - Total State – complete state control over VIM production at all stages of production; 1975–2015; - Production period – characterized by complete quality control means by producers with the state supervision through the production certification and VIM registration in Ukraine since March 2015 to the present time.

Conclusions and prospects for further research: 1. Establishing quality control system VIM in Ukraine can be dated to 1911. 2. The formation of the state system of quality control should CART dated 1931. 3. The VIM quality system evolved from primitive manufacturers control to full government one at all stages of production and became full quality control controlled by producers with mediocre state control at the stage of VIM registration and certification of production. 4. Regulatory framework in the veterinary medicine field requires harmonization with international instruments and the European Union, including documents related to the production and VIM quality control.

Keywords: veterinary, immunobiological preparations, history, quality, control.

REFERENCES

  1. Gorzheуv, V.M. (2014). Problemi zabezpechennja veterinarnogo blagopoluchchja tvarinnictva [The problems of veterinary welfare of livestock]. Naukovyj visnyk veterynarnoi’ medycyny – Scientific Herald of Veterinary Medicine, 13 (108), 5–9 [in Ukrainian].
  2. Bozhko, G.K. (1997). Organіzacіja protiepіzootichnih zahodіv [Organization of anti-epizootic measures]. Kiev: Urozhai [in Ukrainian].
  3. Golovko, A.M., Bloc’ka, O.F., & Protchenko, N.І. (2003). Vikoristannja v ptahіvnictvі Ukraїni veterinarnih іmunobіologіchnih preparatіv ta sistema zabezpechennja їh jakostі [Use in Ukraine poultry veterinary immunological products and their quality assurance system]. Veterinarna medicina – Veterinary Medicine, 53, 547-549 [in Ukrainian].
  4. Golovko, A.M. & Verbic’kij P.І. (2003). Nalezhna virobnicha praktika (GMP) ta nalezhna distrib’jutors’ka praktika (GDP) veterinarnih preparatіv [Good manufacturing practice (GMP) and proper distribution practice (GDP) veterinary drugs]. Kiev: Referat [in Ukrainian].
  5. Kocjumbas, І.Ja. (2013). Slavnij 40-rіchnij juvіlej DNDKІ veterinarnih preparatіv ta kormovih dobavok [Glorious 40th anniversary SSRCI of veterinary drugs and feed additives]. Naukovo-tehnіchnij bjuleten’ Derzhavnogo naukovo-doslіdnogo kontrol’nogo іnstitutu veterinarnih preparatіv ta kormovih dobavok і Іnstitutu bіologії tvarin – Scientific and technical bulletin of the State Research Institute for Veterinary Medicine and Food Additives and Institute of Animal Biology, 16, 2, 13–18 [in Ukrainian].
  6. Іvashhenko, N.V. (2008). Derzhavnij naukovo-kontrol’nij іnstitut bіotehnologії і shtamіv mіkroorganіzmіv - іstorіja і suchasnіst’ [State Scientific Control Institute of Biotechnology and strains – Past and Present]. Veterinarna bіotehnologіja – Veterinary biotechnology, 13(1), 8–17 [in Ukrainian].
  7. Panin, A.N. (2011). FGU «VGNKI» – 80 let [FSI «SSRCI» is 80]. Veterinarija – Veterinary Medicine, 1, 5-11 [in Ukrainian].
  8. Panin, A.N., Sergeeva, T.N., & Dushuk, V.V. et al. (2007). Sovershenstvovanie nacional’noj standartizacii lekarstvennyh sredstv dlja zhivotnyh [Improving the national standardization of medicines for animals]. Veterinarija – Veterinary Medicine, 2, 3–5 [in Ukrainian].
  9. Programma voprosov, podlezhashhih obsuzhdeniju na soveshhanii veterinarnyh vrachej i predstavitelej zemstv Kurskoj gub. [The program issues to be discussed at the meeting of veterinarians and representatives of Zemstvos Kursk province]. (1911). Veterinarnaja zhizn’ – Veterinary life, 19-20, 300 [in Russian].
  10. Soveshhanie veterinarnyh vrachej pri Har’kovskoj gubernskoj zemskoj uprave [Meeting veterinarians at the Kharkiv provincial rural council]. (1911). Veterinarnaja zhizn’ – Veterinary life, 48, 717-719 [in Russian].
  11. Soveshhanie po bakterіologіi, jepidemiologіi i prokaze v Peterburge [Meeting on bacteriology, epidemiology and leprosy in St. Petersburg]. (1911). Veterinarnaja zhizn’ – Veterinary life, 3, 45 [in Russian].
  12. Maksutov, A.M. (1911). Nasha veterinarnaja pressa / Opytnaja protivosapnaja stancіja pri Velikoknjazheskoj stanice i raboty, proizvodimyja v nej [Our veterinary press / Research anti glanderous station at Velikokniazheskaya village and work it performed]. Veterinarnaja zhizn’ – Veterinary life, 50, 743 [in Russian].
  13. Telichenko, E.V. (1916). Iz otcheta o dejatel’nosti veterinarno-bakterіologicheskoj stancіi Ekaterinoslavskogo gubernskogo zemstva za 1914 god [From the report on the activities of veterinary bacteriological station in Ekaterinoslav provincial district council for 1914]. Vistnik obshhestvennoj veterinarіi – Journal of Public Veterinary, 1–2, 39-44 [in Russian].
  14. Soveshhanie po bakterіologіi, jepidemiologіi i prokaze v Peterburge [Meeting on bacteriology, epidemiology and leprosy in St. Petersburg]. (1911). Veterinarnaja zhizn’ – Veterinary life, 11, 170-172 [in Russian].
  15. Hronika / Uchrezhdenie v Parizhe Mezhdunarodnogo jepizooticheskogo bjuro [Chronicle / Establishment in Paris of the Organisation for Animal Health (OIE)]. (1925). Vestnik sovremennoj veterinarii – Journal of modern veterinary medicine, 5, 31-33 [in Russian].
  16. Roїna, O.M. (2007). Veterinarіja v Ukraїnі: normativnі dokumenti [Veterinary in Ukraine: regulations]. K.: KNG [in Ukrainian].
  17. Polozhennja pro provedennja derzhavnogo kontrolju ta nagljadu za jakіstju veterinarnih preparatіv, substancіj, gotovih kormіv, kormovih dobavok ta zasobіv veterinarnoї medicini, jakі zastosovujut’sja v Ukraїnі [Regulations on state control and supervision over the quality of veterinary preparations, substances, ready to feed, feed additives and veterinary drugs used in Ukraine]. (2003). Ofіcіjnij vіsnik Ukraїni – Official Gazette of Ukraine, 25, 330 [in Ukrainian].
  18. Ushkalov, V.O., Postoenko, V.O., & Babkіn M.V. et al. (2011). Perelіk pokaznikіv jakostі dlja veterinarnih іmunobіologіchnih zasobіv [The list of quality indicators for immunological veterinary drugs]. Guidelines. Kiiv: DVFSU, DNKІBShM [in Ukrainian].
  19. Pro viznannja takimi, shho vtratili chinnist’, dejakih nakaziv u galuzi veterinarnoї medicini vіd [On recognition Invalidated, some orders in the veterinary medicine field]. Order of Ministry of Agrarian Policy of Ukraine # 113 from 26.03.2015. Ofіcіjnij vіsnik Ukraini – Official Gazette of Ukraine [in Ukrainian].

Download full text in PDF