CORPORATE NORMATIVE-MANAGEMENT RESERVES IN THE PHARMACEUTICAL PRODUCT MOVEMENT NETWORK

DOI: https://doi.org/None
Issue: 
6
Year: 
2015

N.V. Chukreeva, PhD; Professor E.A. Maksimkina, PhD I.M. Sechenov First Moscow State Medical University; 8, Trubetskaya St., Moscow 119991

The functioning of the pharmaceutical industry of the Russian Federation as a national structural component of the global pharmaceutical product movement network requires the introduction of an innovative quality management paradigm that is in the holistic view of all business processes in the supply chains. The definition of quality management system, which is proposed by the European Union guidelines on good wholesale distribution practice (GDP) of drugs, has been analyzed. The key structural elements of the quality management system for organizations in the drug movement network have been identified. The role of an authorized person responsible for quality, who is an ideologist of an internal corporate normative approach to the quality and processes accomplishing with medicinal products, has been substantiated. The results of a sociological survey of Russian pharmaceutical workers trained according to the advanced professional programs at the Sechenov Moscow State Medical University are given. It is concluded that a large number of pharmaceutical chemists realize the main pharmaceutical mission of the goods movement network in maintaining the constancy of drug quality on the way from manufacturer to patient. The authors have revealed that the need for standardizing the processes via standard operating procedures as a primary corporate standard for internal normative management reserves is of paramount importance.

Keywords: 
medicines
goods movement network
quality management
business processes
standard operating procedures
pharmaceutical workers
corporate normative reserves

References: 
  1. Novaya evropeyskaya politika zdravoohraneniya. Zdorov`e – 2020: videnie, cennosti, osnovnye napravleniya i podhody. Pervaya Evropeyskaya konferenciya VOZ po novoy evropeyskoy politike zdravoohraneniya. Zdorov`e – 2020 – VOZ. Evropeyskoe regional`noe byuro – http://www.who.int/workforcealliance/knowledge/resources/health2020/ngcall/en – C.183 [The new European policy for health – Health 2020.Policy framework and strategy. World Health Organization regional office for Europe.http://www.who.int/workforcealliance/knowledge/resources/health2020/ngcall/en – P. 183 (in Russian).
  2. Strategiya lekarstvennogo obespecheniya naseleniya Rossiyskoy Federacii do 2025 g. Ministerstvo zdravoohraneniya RF. Prikaz № 66 ot 13 fevralya 2013 g. «Ob utverzhdenii Strategii lekarstvennogo obespecheniya naseleniya. Rossiyskoy Federacii na period do 2025 goda i plana ee realizacii».[Strategy for pharmaceutical provision of the RF population until 2025. Russian Federation Ministry of Healthcare. Order dated 13 of February 2013 № 66 «About approval of the strategy for pharmaceutical provision of the RF population until 2025 and schedule of its implementation»] (in Russian).
  3. Chukreeva N.V. Analiz ponimaniya provizorami aptechnyh organizaciy osnovnyh principov sistemy farmacevticheskogo kachestva. N34 «Nauchnaya diskussiya: voprosy mediciny»: materialy XIV Mezhdunarodnoy zaochnoy nauchno-prakticheskoy konferencii. (2013 g.) Moskva: «Mezhdunarodnyy centr nauki i obrazovaniya», 2013; 85–89.[Chukreeva N.V. Assessment of comprehension by pharmaceutical staff of pharmacies the general principles of pharmaceutical quality management. H34 «Scientific discussion: questions of medicines»: XIV international scientific-practical conference by correspondence (2013). Moscow: «International center of science and practice», 2013; 85–89 (in Russian)].
  4. European Commission Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C 343/01). Official Journal of the European Union. 343/1–343/14.