Osiguranje i kontrola kakvoće galenskih pripravaka

Professional paper - Review paper

• Author: Jelena Jelaska
• Author: Biljana Nigović
• Author's institution: University of Zagreb; Faculty of Pharmacy and Biochemistry; (Department of pharmaceutical analysis)
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract (english)

According to the Medicinal Product Act, the offi cinal formula in Croatia can be prepared in pharmacies as well as in offi cinal 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 offi cinal formula preparation. Th e ordinances projected by the Medicinal Products Act and the Act on Pharmacy have not been enacted by the time this paper was written. Th e existing professional guides do not provide enough information concerning their preparation and quality control. Th e preparation and quality assurance of pharmacy formulations are subjects of national regulation, therefore there are signifi cant diff erences 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 diff erences 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. Th ere 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 offi cinal formula and cosmetic products). Th e preparations were analyzed in the Laboratory of the quality control of the offi cinal formula and identifi cation of the medicinal substances of Pharmacy of Split-Dalmatian County. Th e samples were obtained by mystery shopping. Th e scope of the present study was to determine the quality of two kinds of offi cinal 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 effi cient and eff ective quality assurance and quality control system has not been established yet.

• Keywords (croatian): galenski pripravci; magistralni pripravci; kontrola kakvoće lijeka
• Language: croatian
• Publication type: Professional paper - Review paper
• Publication status: Published
• Peer review: Peer review - domestic
• Publication version: Published version
• Journal title: Farmaceutski glasnik
• Numbering: vol. 72, no. 7-8, pp. 465-483
• p-ISSN: 0014-8202
• URN:NBN: urn:nbn:hr:163:528647
• Publication: 2016
• Type of resource: Text
• Access conditions: Open access
• Created on: 2020-05-12 15:56:43