Author/Editor		Cvelbar, Martina; Kočevar-Nared, Jasna
Title		Kontrola kakovosti krvnih izdelkov v Republiki Sloveniji
Translated title		Quality control of human blood products in Republic of Slovenia
Type		članek
Source		Zdrav Vestn
Vol. and No.		Letnik 73, št. Suppl 1
Publication year		2004
Volume		str. I-143-6
Language		slo
Abstract		Background. Institute of Pharmacy and Drug Research is a competent authority for post-licensing analytical control of medicines on their quality and safety on Slovenian market. Human blood products as a possible way for transmiting some viruses, represent potential danger for the donor pacient. Slovenian act on medicines classifies these products as risky medicines and put more strict postlicensing quality control prior to release of each batch on the market, so called a special quality control Equally, human blood products in EU market are subjects to a more unitary post-licensing quality control and release procedure named the Official Control Authority Batch Release (OCABR procedure). Conclusions. In present article four years experiences on special quality control of human blood products on Slovenian market are presented. The most frequent reason for negative results after special control of human blood products is uncomplete documentation for every batch of the human blood products prior to its placement to the market. Other deficiences are classified into four major groups: disaccordances with the demands of Slovenian subsidary act, disaccordances with marketing authorisation dossier, disaccordances with the nomenclature and group of others deficiences and disaccordances.
Summary		Izhodišča. Zavod za farmacijo in za preizkušanje zdravil - Ljubljana je pristojen za analizno preizkušanje zdravil Namen preizkušanja je preverjanje njihove kakovosti in varnosti na trgu Republike Slovenije. Krvni izdelki so zaradi možnosti prenosa nekaterih virusov lahko potencialno nevarni za prejemnika. Naša zakonodaja s področja zdravil jih zato uvršča v rizično skupino zdravil. Zanje je predpisan strožji nadzor glede njihove kakovosti pred sprostitvijo v promet, t. i. posebna kontrola kakovosti. To je skupina izdelkov, ki se tudi v evropskem prostoru obravnava posebej skrbno. Obravnavajo jo po postopku enotne kontrole in sproščanja krvnih izdelkov na trg (Official Control Authority Batch Release postopek OCABR. Zaključki. V članku so predstavljeni rezultati štiriletnega izvajanja posebne kontrole kakovosti humanih krvnih izdelkov, ki so v prometu na slovenskem trgu. Najpogostejši vzrok za odstop od kakovosti je bila nepopolna, zakonsko določena, spremljajoča dokumentacija za vsako serijo zdravila, ki je šla v promet. Druge ugotovljene pomanjkljivosti in neskladnosti smo razvrstili v štiri večje skupine: neskladnosti z zahtevami zakonodaje glede označevanja zdravila, neskladnosti z veIjavno dokumentacijo, pravilnost strokovnega izrazoslovja in ostale ugotovljene pomanjkljivosti in neskladnosti.
Descriptors		BLOOD COMPONENT TRANSFUSION QUALITY CONTROL SERUM ALBUMIN BLOOD COAGULATION FACTORS IMMUNOGLOBULINS ANTITHROMBINS FIBRIN TISSUE ADHESIVE