Letno poročilo 2005

azvojnim in proizvodnim projektom ob
zaostrovanju kakovostnih zahtev za izvajanje
tak{nih del. Konceptualno predstavlja novi
model izvajanja nalog za potrebe industrije, ki
smo ga v l. 2005 nadalje uspe{no razvijali ter
organizacijsko in vsebinsko prilagajali potrebam
naro~nikov. Tako smo raz{irili spekter tehnik
plinske kromatografije ter uvedli tehnike za
dolo~anje hitrosti raztapljanja u~inkovin iz
kon~nih farmacevstkih izdelkov. Delo v CVTA
poteka ob strokovni podpori Laboratorija za
prehrambeno kemijo (L06).
V l. 2005 smo za slovensko farmacevtsko
industrijo izvedli:
- razvoj 8 analitskih postopkov
- validacijo 67 HPLC, GC in TLC analitskih
postopkov
- analize za validacijo ve~ proizvodnih tehnologij
- analize za validacije ve~ tehnologij ~i{~enja
proizvodne opreme
SLIKA:
Delo na HPLC sistemu
Center za validacijske tehnologije in analitiko (CVTA)
Centre for Validation Technologies and Analytics (CVTA)
trial partners. In this respect we have broaden
a spectrum of gas chromatography techniques,
and introduced techniques of dissolution testing
important for evaluation of finished dosages
forms. All the activities were performed in
tight collaboration with L06, which offered professional
support of its experts to CVTA.
Crucial achievements in the year 2005 are:
- Development of 8 analytical methods
- Validation of 67 HPLC, GC in TLC analytical
methods
- Analyses for several process validations
- Analyses for several cleaning validations
- Analyses for stability studies
- Analyses of residual solvents (OVI) in approximately
550 samples of pharmaceutical finished
dosage forms.
All activities were performed according to GLP
and/or GMP standards.
FIGURE:
Working on HPLC system
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