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Risk management in pharma business based ISO 31 000

Upravljanje rizikom u farmaciji na osnovu ISO 31 000

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2008
1083.pdf (241.6Kb)
Authors
Marinković, Valentina
Tasić, Ljiljana
Majstorović, Vidosav D.
Article (Published version)
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Abstract
Risk management process has been originally applied in finance, but it has been developed very fats in the other parts of industry. Pharma business is notified as an area of high risk, so the standards that describe risk management processes (GMP, ISO 14001, OHSAS 18001) have been already implemented in the majority of pharmaceutical companies. In this paper the guidelines on principles ad implementation of risk management according the model ISO 31000 in pharma business have been done. Standard ISO 31000 has arrived 'just in time', because of integrated processes in risk management in pharma business regarding safety and quality of medicines, as well as risk management in Environmental, Health and Safety area.
Zahtevi za upravljanja rizikom su se prvo javili u finansijama, ali su se brzo pojavili i u ostalima granama industrije. Polazeći od činjenice da je farmaceutsko poslovanje rangirano kao oblast visokog rizika, standardi koji opisuju procese, odnosno imaju specifične zahteve za upravljanje rizikom (GMP, ISO 14001, OHSAS 18001) su već implementirani u većini kompanija koje se bave proizvodnjom lekova. U ovom radu prikazani su osnovni principi i smernice za upravljanjem rizika po modelu ISO 31000, uz osvrt na farmaceutsku delatnost, sa posebnim akcentom na spoljašnje faktore koji utiču na procese upravljanje rizikom. Standard ISO 31 000 je došao u pravi čas, jer će pomoći da se u farmaceutskom poslovanju integrišu sve aktivnosti u upravljanju rizikom, bilo da se odnose na kvalitet leka i bezbednost pacijenta, bilo da se odnose na zaštitu životne sredine i bezbednosti na radu.
Keywords:
risk management / decision making / pharma business / upravljanje rizikom / donošenje odluka / farmaceutsko poslovanje
Source:
Tehnika - Kvalitet, standardizacija i metrologija, 2008, 8, 4, 1-5
Publisher:
  • Savez inženjera i tehničara Srbije, Beograd

ISSN: 1450-989X

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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/1085
Collections
  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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