Pregled bibliografske jedinice broj: 500396
Regulatory and quality aspects related to transportation of pharmaceuticals
Regulatory and quality aspects related to transportation of pharmaceuticals // 12th International Conference on Transport Science - ICTS 2009 / Marina Zanne, Patricija Bajec (ur.). - Portorož : Fakulteta za pomorstvo in promet, Portorož , 2009. (ISBN: 978-961-6044-90-5). / Marina Zanne, Patricija Bajec (ur.).
Portorož: Fakulteta za pomorstvo in promet Univerza v Ljubljani, 2009. str. 1-11 (ostalo, međunarodna recenzija, cjeloviti rad (in extenso), znanstveni)
CROSBI ID: 500396 Za ispravke kontaktirajte CROSBI podršku putem web obrasca
Naslov
Regulatory and quality aspects related to transportation of pharmaceuticals
Autori
Majić, Zvonimir ; Bishara, Rafik ; Pavlin, Stanislav
Vrsta, podvrsta i kategorija rada
Radovi u zbornicima skupova, cjeloviti rad (in extenso), znanstveni
Izvornik
12th International Conference on Transport Science - ICTS 2009 / Marina Zanne, Patricija Bajec (ur.). - Portorož : Fakulteta za pomorstvo in promet, Portorož , 2009. (ISBN: 978-961-6044-90-5).
/ Marina Zanne, Patricija Bajec - Portorož : Fakulteta za pomorstvo in promet Univerza v Ljubljani, 2009, 1-11
ISBN
978-961-6044-87-5
Skup
12th International Conference on Traffic Science- ICTS
Mjesto i datum
Portorož, Slovenija, 04.06.2009. - 05.06.2009
Vrsta sudjelovanja
Ostalo
Vrsta recenzije
Međunarodna recenzija
Ključne riječi
Good Distribution Practice; regulatory requirements; transportation interface; stakeholder mentality; important elements in transportation processes
Sažetak
The pharmaceutical industry is one of the most regulated industries today. The globalization effects resulted in the need for even stricter regulations in distribution thus aiming to harmonize standards for good manufacturing, storage and distribution practices. A number of regulatory bodies and organizations led by the World Health Organization, United Kingdom’s Medicines and Healthcare Products Regulatory Agency, International Air Transport Association, and others, have regulated and recommended the standards for the air transportation of pharmaceutical products. The distribution comes into the focus as a weak link often neglected in global efforts towards the patient safety. The supply chain grows more complex thus burdening the quality level in cool chain management. Transport needs to account for specific requirements against its realistic capabilities considering regulatory issues and recommendations issued by the industry leading advisory bodies. The defined processes recognizing the entity’s character are of essence in contribution to the overall good distribution practice. The paper takes into consideration the regulatory environment against the overall transportation process structure.
Izvorni jezik
Engleski
Znanstvena područja
Tehnologija prometa i transport
