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Projects / Programmes source: ARIS

Validation of Analytical Procedures in Chemical and Pharmaceutcal Industry

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Research activity

Code Science Field Subfield
2.02.03  Engineering sciences and technologies  Chemical engineering  Process system engineering 

Code Science Field
T125  Technological sciences  Automation, robotics, control engineering 
Keywords
GLP, GMP, FDA, Accreditatin, Quality assurance, Quality assesment, Validation
Evaluation (rules)
source: COBISS
Evaluation of bibliographic research performance indicators according to ARIS methodology
Citations Citations for bibliographic records in COBIB.SI that are linked to records in citation databases
source: WoS source: Scopus source: COBISS
Researchers (6)
no. Code Name and surname Research area Role Period No. of publications
1.  06787  PhD Alenka Golc Wondra  Plant production  Researcher  1999 - 2001  210 
2.  06532  Adolf Krašna  Chemistry  Researcher  1999 - 2001  41 
3.  01095  PhD Mirko Prošek  Chemistry  Head  1999 - 2001  406 
4.  15461  PhD Breda Simonovska  Plant production  Researcher  1999 - 2001  247 
5.  05397  PhD Andrej Šmidovnik  Chemistry  Researcher  1999 - 2001  131 
6.  11395  PhD Irena Vovk  Chemistry  Researcher  1999 - 2001  564 
Organisations (1)
no. Code Research organisation City Registration number No. of publications
1.  0104  National Institute of Chemistry  Ljubljana  5051592000  20,996 
Abstract
The introduction of Good Laboratory Practice GLP is very important task, which is necessary for participation of our state in EU and OECD. According to our good results in application of GLP in our laboratory we shall in next few years develop new separation techniques and methods in cooperation with Slovenian pharmaceutical industry (LEK, KRKA). All new methods will be validated. These method will be used in quantitative determination of active substances in pharmaceutical formulations and biological samples. Inside the National Institute of chemistry we shall develop an adequate quality assurence program and quality assurance unit. According to our efforts on harmonization of analytical methods and introduction of GLP we shall cooperate with some foreign institution. This cooperation will help us to find new criteria for correct evaluation of some methods and techniques.
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