Naslov
Osiguranje i kontrola kakvoće galenskih pripravaka
(Quality assurance and quality control of pharmacy preparation (officinal formula))

Autori
Jelaska, Jelena ; Nigović, Biljana

Izvornik
Farmaceutski glasnik : glasilo Hrvatskog farmaceutskog društva (0014-8202) 72 (2016); 465-483

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, pregledni rad, stručni

Ključne riječi
Galenski pripravci; osiguranje kvalitete; kontrola kvalitete
(Officinal formula; quality assurance; quality control)

Sažetak
According to the Medicinal Product Act, the officinal formula in Croatia can be prepared in pharmacies as well as in officinal formula laboratories and can be placed on the market without marketing authorization. By reviewing Croatian legislation, one can notice the absence of the regulatory framework when referring to the officinal formula preparation. The ordinances projected by the Medicinal Products Act and the Act on Pharmacy have not been enacted by the time this paper was written. The existing professional guides do not provide enough information concerning their preparation and quality control. The preparation and quality assurance of pharmacy formulations are subjects of national regulation, therefore there are significant differences concerning the extent and the mode of their regulation on the European level. However, in the majority of the European countries, there is a strong regulatory base for this sphere of pharmacy profession. On the European level, the need for identifying those differences has been recognized. In order to harmonize the regulations, Committee of Ministers of the Council of Europe adopted the Resolution CM/ResAP(2011)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. It is recommended to transpose those guidelines into national legislations. There are no reports on the quality of pharmacy preparations in Croatia so far. In this paper the results of the pilot study on quality control of pharmacy preparations are presented (both officinal formula and cosmetic products). The preparations were analyzed in the Laboratory of the quality control of the officinal formula and identification of the medicinal substances of Pharmacy of Split- Dalmatian County. The samples were obtained by mystery shopping. The scope of the present study was to determine the quality of two kinds of officinal and cosmetic preparations prepared in 13 public pharmacies in 5 Croatian towns. According to the results of the study, on the limited number of samples, one can conclude that that efficient and effective quality assurance and quality control system has not been established yet.

Izvorni jezik
Hrvatski

Znanstvena područja
Farmacija

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