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Mikrobiološka kakovost farmacevtskih izdelkov
Resnik, Meta (Author), Kerč, Janez (Author)

URLURL - Presentation file, Visit http://www.dlib.si/details/URN:NBN:SI:doc-W5GBVDNL This link opens in a new window

Abstract
Farmacevtska industrija velja za eno najbolj reguliranih proizvodnih okolij, saj neposredno vpliva na zdravje oeloveka. Velik delež k temu prispeva tudi mikrobiološka kontrola farmacevtskih izdelkov, na katero vpliva bodisi okolje,v katerem jih izdelujemo, bodisi snovi, ki jih uporabljamo v farmacevtskih oblikah. V današnjem načinu proizvodnje, z zagotavljanjem kakovosti kot prvim pogojem izvajanja dobre proizvodne prakse, želimo z natančnimi postopki preprečiti mikrobno kontaminacijo v vseh izdelkih. Farmacevtska podjetja se trenutno srečujejo z zahtevno nalogo izvrševanja harmonizacije zahtev, ki naj bi kljub poenotenju nudile še močnejšo osnovo za zagotavljanje varnosti izdelkov. Poleg mikroorganizmov, ki so pomembni v farmacevtski industriji, so v članku predstavljeni ključni dejavniki, ki vplivajo na mikrobno kontaminacijo farmacevtskih izdelkov in različni testi za mikrobiološko kontrolo kakovosti izdelkov.

Language:Slovenian
Keywords:mikrobiološka kontrola, mikrobna kontaminacija, limitni testi, test sterilnosti, harmonizacija
Work type:Not categorized (r6)
Tipology:1.02 - Review Article
Organization:FFA - Faculty of Pharmacy
Year:2010
Publisher:Slovensko farmacevtsko društvo
Number of pages:str. 23-29
Numbering:Letn. 61, št. 1
UDC:579.6
ISSN on article:0014-8229
COBISS.SI-ID:2780529 Link is opened in a new window
Views:1225
Downloads:91
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Record is a part of a journal

Title:Farmacevtski vestnik
Shortened title:Farm. vestn.
Publisher:Slovensko farmacevtsko društvo
ISSN:0014-8229
COBISS.SI-ID:3105794 This link opens in a new window

Secondary language

Language:English
Title:Microbiological quality of pharmaceutical products
Abstract:
Pharmaceutical industry is known to be one of the most regulated production environments because of its direct effect on human health. Microbiological quality control of pharmaceutical products contributes a huge part to this whether it is the production environment that mostly affects them or the substances which are used in the products. With quality assurance as the first approach of performing good manufacturing practice in todayćs production the aim is to prevent microbial contamination in every product. Nowadays pharmaceutical companies are dealing with pretentious implementation of harmonised regulations which would offer even better basis for productćs quality. Besides microorganisms found in pharmaceutical industry, factors affecting microbial contamination, microbiological control and different testsare reviewed in the article.


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