Značaj usaglašenosti laboratorija farmaceutske industrije sa zahtevima međunarodnih standarda u kontekstu povećanja konkurentnosti

Abstract

U ovom radu pošlo se od značaja usaglašenosti laboratorija farmaceutske industrije sa zahtevima međunarodnih standarda sa aspekta povećanja konkurentnosti farmaceutskih kompanija. Prikazana je komparativna analiza zahteva standarda ISO/IEC 17025 koji se primenjuju dobrovoljno, ali koji su već implementirani u velikom broju kompanija širom sveta i zahteva cGMP (current Good Manufacturing Practice), koji će od 2010. godine biti deo zakonske regulative u Republici Srbiji, i to segmenta koji se odnosi na laboratorije kontrole kvaliteta u preduzećima farmaceutske industrije. Cilj ovoga rada je da ukaže na mogućnost istovremenog zadovoljenja i jednih i drugih zahteva, čime bi se laboratorijama farmaceutske industrije otvorio put za različite vidove međulaboratorijske saradnje u domaćim i u međunarodnim okvirima.

Current Good Manufacturing Practice (cGMP) being a legal regulation in developed countries will become a legal regulation in Republic of Serbia starting with March 2010. In this paper comparative analysis between requirements of standard ISO/IEC 17025 and requirements of cEU GMP is shown. Considering the fact that in Republic of Serbia no pharmaceutical industry laboratory has been accredited according to requirements of ISO/IEC 17025, while keeping in mind that more than 90% of these laboratories have not fulfilled cEU GMP requirements, this paper aimed at pointing to the possibility of fulfilling both of mentioned requirements at the same time, which would open the way to different types of interlaboratory cooperation for pharmaceutical quality control laboratories and contribute to improving competitiveness of pharmaceutical companies. Accreditation, especially in the case of pharmaceutical quality control laboratories, is important because it guaranties the level of organizational and technical competency. It could easily be said that accreditation is becoming a must in quality control of products in order for the organization to be able to gain a leading role in the global market. Both accreditation and cGMP show the organization's commitment to having products of highest quality level. Considering the above mentioned facts, it is of greatest advantage for pharmaceutical quality control laboratories to fulfill both requirements of ISO/IEC 17025 and cGMP and reach total compliance. The aim of doing this lies in an easier acceptance of pharmaceutical products in different markets, overcoming technical barriers and affirmation of quality as key factor in reaching competitiveness, while keeping in mind the importance of strategic and competitive positioning in the global market.