Legal-legal basis of improvement of continuing education staff enterprises industrial pharmacy. P a r t I. Draft Regulation on certification, licensing and certification of personnel pharmaceutical industry enterprises

  • Yu. V. Voronenko National Medical Academy of Post-graduate Education named P. L. Shupyk, Kyiv
  • M. S. Ponomarenko National Medical Academy of Post-graduate Education named P. L. Shupyk, Kyiv
  • O. S. Solovyov National Medical Academy of Post-graduate Education named P. L. Shupyk, Kyiv
  • V. P. Chernyh National University of Pharmacy, Kharkiv
  • V. M. Tolochko National University of Pharmacy, Kharkiv
Keywords: certification, licensing, staff of enterprises Industrial Pharmacy, postgraduate training

Abstract

Good manufacturing practice requirements , combine to provide a system efficiency of drugs in outstanding quality depends on the human capacity. System of product quality, the appropriate level of staff should be fully documented and its effectiveness – controlled. Thus, all components of the system, its subsystems, components should properly be provided by qualified personnel. Each employee should clearly understand individual responsibility, which should be documented . Level of professional competence should be subordinate appropriate certificate universities III–IV accreditation levels. In Ukraine there is still such criteria are not normalized to the staff.

The aim of the work was the creation , development and approval of the draft resolution of the Cabinet of Ministers of Ukraine and the Regulations on the licensing, certification  of enterprises for the production of medicines.

Studies were conducted on the basis of a retrospective analysis methods of the current state of postgraduate education staff training, retraining and certification pharma companies.

The proposed draft resolution of the Cabinet of Ministers of Ukraine regarding the Regulation on licensing and certification training companies Industrial Pharmacy provides a basis to eliminate obstacles to the implementation of the constitutional right to post-graduate education and improvement of personnel of the enterprises of the pharmaceutical industry.

Proposed a draft resolution of the Cabinet of Ministers «Regulations on the licensing and certification of professional level staff in the production of medicines». Decision of the Government of Ukraine can end continuation of heated discussions regarding implementation of permanent improvements and postgraduate certification of personnel in the field of medicines and pharmaceutical activities in Ukraine.

References

1. Borisevich VB, Kaplunenko V.G., Kosinov MV and others. Nanomaterials in biology. Fundamentals of Nanotechnology - K .: "Avicenna", 2010. - 416 p.
2. Volkov SV, Kovalchuk S.P., Genko V. M., Reshetnyak O. V. Nanochemistry. Nanosystems Nanomaterials - K .: Science. opinion, 2008. - 422 pp.
3. O. M. Gritsenko, M. S. Ponomarenko, A. A. Babsky and others. Ethical declaration of the behavior of specialists in the field of creation, production, circulation, promotion and advertising of medicinal products (pharmacies, drugstores). - K.: Print Quic, 2007. - 12 p.
4. Zagory VA Complex program-target management of production of medicines in the conditions of implementation of GMP rules in the pharmaceutical enterprise: Dis. ... Dr. farm. Sciences: 15.00.01. - Kharkiv, 2002. -361 p.
5. Zaporozhan VN The Way to Nooetics. - Odessa: Odessa. state honey. Unt., 2008. - 284 pp.
6. Classifier of professions DK 003: 2010 / SD "Research Institute of Social-Labor Relations, Municipal Social. Policy of Ukraine ", Institute of Ukrainian Studies. Languages of the National Academy of Sciences of Ukraine, State Statistics Committee of Ukraine. - K .: Sotsinform, 2010. - 745 p.
7. Movchan B. A. Electron-beam hybrid nanotechnology of deposition of inorganic materials in vacuum / Actual problems. sovr material science. - K.: Academiperiodika, 2008. - Vol. 1. - P. 227 - 247.
8. Proper medical practice of medicine / Ed. N. A. Lyapunov, V. Zagoria, V. P. Georgievskii and others - K.: Morion, 1999. - P. 52-60.
9. Paliy V. Astrologer and fortune teller in law, or do we need such a classification of professions? // Bulletin of the Higher Attestation Commission of Ukraine. - 2010. - No. 11. - P. 36-38.
10. Paton B. E., Moskalenko V. F., Chekman I. S., Movchan B. O. Nanoscience and Nanotechnology: Technical, Medical and Social Aspects // Vysn. National Academy of Sciences of Ukraine. - 2009. - No. 6. - P. 76-80.
11. Ponomarenko MS, Zagory GV, Babsky AA and others. Noofarmatichesky, scientific and practical substantiation for the creation of qualification characteristics of employees of the newly created positions in the Ukrainian labor market from the emergent and poetic positions. Noofarmatsiya // Odessa. honey. journ - 2011. - No. 3. - P. 15-20.
12. Ponomarenko MS, Solovyov O. S., Kirpach O. V. and others. Noofarmacy, Pharmacoeconomics in Science, Education, Practice / Management and Marketing in the Contemporary Economy, Science, Education, Practice: Mater. intern science-practice Internet Conf. (Kharkiv), March 28-29, 2013 / Ed. Z. Mnushko and others. - Kharkiv: View of the NFUU, 2013. - P. 366-367.
13. Storozhuk Y. Ban can not be advertised / Yu.Stroozhuk / / Recipes pharmacy sales. - 2012. - No. 3. - P. 14-15.
14. Trakhtenberg I. M., Ulberg Z. R., Chekman I. S. Nanoscience: terminological and substantive aspects // The art of treatment. - 2013. - № 7. - S. 42-44.
15. Chekman I.S., Simonov P.V. Natural Nanostructures and Nanomechanisms. - K.: The Other, 2012. - 104 p.
16. Chekman I. S. Nanopharmacology. - K: A friend. 2011. - 424 pp.
17. Chekman I. S., Ulbert Z. R., Malaychuk V. O. and others. - Nanoscience, nanobiology, nanofarmation. - K.: Polygraph plus, 2012. - 328 p.
18. Allhoff F., Lin P. What's So Special About Nanotechnology and Nanjethics? // Int. J. Appl. Phil - 2008. - V. 20, N 2. - P. 179-190.
19. Ashai Z. A., Pukhta MA, Abbas Z. et al. Nanopharmecology // JK-Practitioner. - 2012. - V. 17, N 1-3. - P. 83-85.
20. Good manufacturing practices for pharmaceutical products // WHO Expert Committee on Specifics for Pharmaceutical Preparations: Thirty-second Report. - Geneva: World Health Organization, 1992 (WHO Technical Report Series, No. 823). - P. 14-79.
21. European Pharmacopea, Suppl. - 4 ed. Council of Europe - Strasbourg: EDQM, 2001 - 2415 p.
22. USP Pharmacists' Pharmacopea. - 2 nd ed. - Rockville: The United State Pharmacopea, Inc., 2008 - 1519 p.
23. Medina C., Santos-Martinez M. J., Radomski A. et. al. Nanoparticles pharmacological and toxicological significance // Br. J. Pharmacol. - 2007. - P. 150. - P. 552-558.
24. Megawati O. Nanopharmacy - opportunities and prospects: a perspective from the Nanopharmacy Research Laboratory. - Access mode: http: //www.researchsea.com/html/article.php/aid/5269/cid/1/reseach/nanopharmacy_possiblities_and_prospects_aperspective_from_nanopharmacy_research_laboratory.html?PHPSESSID=7ha650chdip7cvoshqi9recq2
25. Kawasaki E. S., Player A. Nanotechnology, nanomedicine, and the development of new, effective therapies for cancer // Nanomedicine. - 2005 - V. 1, N 2. - P. 101-109.
26. Rivera G. P., Huhn D., de Mercato L. L. et al Nanopharmacy: inorganic nanoscale devices as vectors and active compounds // Pharmacol. Res - 2010. - V. 62, N 2. - P. 115-125.
Published
2019-02-12
How to Cite
Voronenko, Y. V., Ponomarenko, M. S., Solovyov, O. S., Chernyh, V. P., & Tolochko, V. M. (2019). Legal-legal basis of improvement of continuing education staff enterprises industrial pharmacy. P a r t I. Draft Regulation on certification, licensing and certification of personnel pharmaceutical industry enterprises. Farmatsevtychnyi Zhurnal, (3), 3-12. Retrieved from https://pharmj.org.ua/index.php/journal/article/view/281
Section
Management of pharmacy