Abstract
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.
Highlights
GMP u ovom delu ima prednost za farmaceutske laboratorije, trebalo bi samo deo o etaloniranju i mernoj sledljivosti preuzeti iz ISO standarda
It could 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
Summary
U ovom radu pošlo se od značaja usaglašenosti laboratorija farmaceutske industrije sa zahtevima međunarodnih standarda sa aspekta povećanja konkurentnosti farmaceutskih kompanija. (United States Code) deo 351(a)(2)(B) [6], kompanija mora demonstrirati usaglašenost sa svim primenljivim cGMP regulativama, u ovom slučaju od 210 do 226, kao i sa zahtevima svih internacionalnih ISO standarda, koji pokrivaju one aktivnosti kojima se kompanija bavi. GMP u ovom delu ima prednost za farmaceutske laboratorije, trebalo bi samo deo o etaloniranju i mernoj sledljivosti preuzeti iz ISO standarda. U delu koji se odnosi na sklapanje ugovora detaljnije zahteve daje GMP i u ovom delu bi trebalo te zahteve primeniti, uz obavezno obaveštavanje korisnika kada se podugovaraju ispitivanja, zato što se tako postiže usaglašenost i sa zahtevima ISO standarda. ISO standard je detaljniji u pogledu toga šta bi izveštaj trebalo da sadrži, opisuje izmene izveštaja, zahteva da se naglasi deo posla koji je poveren podugovaračima, standardizovanje forme izveštaja, davanje mišljenja i tumačenja. ISO standard daje detaljnije zahteve u pogledu izveštavanja, tako da zadovoljenje ovih zahteva zadovoljava i zahteve GMP-a
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