QUALITY CONTROL OF HUMAN BLOOD PRODUCTS IN REPUBLIC OF SLOVENIA
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.
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