Letno poročilo 2005

Center za validacijske tehnologije in analitiko (CVTA)
Centre for Validation Technologies and Analytics (CVTA)
PODRO^JA DEJAVNOSTI
CVTA na~rtuje in izvaja razvojno-analitske
storitve na podro~ju zdravil in prehrane; njegova
dejavnost obsega:
- razvoj HPLC, GC, TLC in drugih analiznih
postopkov ter postopkov za dolo~anje hitrosti
raztapljanja
- na~rtovanje in izvedbo validacij analiznih
postopkov
- izvajanje analiz in analiznih {tudij za potrebe
kontrole kakovosti izdelkov ter validacij
proizvodnih tehnologij in tehnologij ~i{~enja
proizvodne opreme
- izvajanje bioanaliznih za {tudij biorazpolo`ljivosti
oz. bioekvivalentnosti zdravil
- validacije analiznih metod in tehnologij z
navedenimi tehnikami
- izdelavo ekspertnih mnenj in svetovanja na
podro~ju dejavnosti.
Aktivnosti potekajo v skladu s standardi dobre
laboratorijske oz. dobre proizvodne prakse.
GLAVNI DOSE@KI V LETU 2005
CVTA sledi nara{~ajo~im potrebam slovenske in
tuje farmacevtske industrije po analitski podpori
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ACTIVITIES
CVTA designs and perform the foolowing activities
related to medicines and food:
- development of HPLC, GC, TLC, dissolution
testing and other analytical procedures
- analyses and analytical studies for quality
control of products, and validation of production
and cleaning technologies
- bioanylitical studies of bioavailability and
bioequivalence
- validation of analytical methods and technologies
- preparation of expert opinions and consulting.
Activities are performed according to GLP and/
or GMP standards.
IMPORTANT ACHIEVEMENTS IN 2005
CVTA follows the increasing needs of pharmaceutical
industry for analytical support to their
R&D and production projects, combined with
sharpening requirements of quality standards.
In principle it represents a novel organizational
model, which was in 2005 successfully further
developed and adjusted to the needs of indus-