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Title:Vpliv standardov, regulatornih zahtev in smernic dobre proizvodne prakse na proces integracije procesnega sistema tehnološke opreme v operativno okolje farmacevtske industrije : magistrska naloga
Authors:ID Janež, Rok (Author)
ID Delak, Boštjan (Mentor) More about this mentor... New window
Files:.pdf MAG_2019_Rok_Janez.pdf (1,14 MB)
MD5: 59FBEA9543ED8096148C97B7CF1B0070
 
Language:Slovenian
Work type:Master's thesis/paper
Typology:2.09 - Master's Thesis
Organization:FIŠ - Faculty of Information Studies in Novo mesto
Abstract:Danes skoraj, da ni industrije oziroma podjetja, ki pri izdelavi produkta ne bi uporabljala naprednih delovnih strojev oziroma avtomatizirane tehnološke opreme. Ta je navadno zaradi lažjega in boljšega nadzora upravljana s pomočjo naprednega računalniškega sistema, ki s svojimi komponentami narekuje tehnološki opremi, kako naj se v dani situaciji odzove ter beleži vse aktivnosti in podatke, ki jih lahko s pomočjo različnih naprav in programskih rešitev beležimo in kasneje tudi obdelujemo. A takšno tehnološko opremo je treba v delovno okolje naprej vpeljati, jo pripraviti za delo, ter začrtati smernice obvladovanja delujočega stanja. Vpeljava računalniškega sistema tehnološke opreme predstavlja na tem mestu poseben izziv. Zaradi tehnične kompleksnosti in velikega vpliva procesnih informacijskih sistemov na delovanje avtomatizirane tehnološke opreme in s tem posredno na kakovost končnega izdelka so takšni računalniški sistemi podvrženi številnim zahtevam zakonodajnih in regulatornih organov. Magistrska naloga se skozi svoja poglavja spušča v podrobnosti standardiziranega pristopa k procesu vpeljave računalniškega sistema v produkcijsko okolje farmacevtske industrije. Pri tem v ospredje postavlja zahteve regulatornih organov ter smernice dobre proizvodne prakse.
Keywords:proizvodna, avtomatizirano, procesni sistemi, GMP, GAMP, FDA
Place of publishing:Novo mesto
Place of performance:Novo mesto
Publisher:[R. Janež]
Year of publishing:201
Year of performance:201
Number of pages:XI, 89 str.
PID:20.500.12556/ReVIS-6069 New window
COBISS.SI-ID:2048613139 New window
UDC:004.825:338.45:615.15(043.2)
Note:Na ov.: Magistrska naloga : študijskega programa druge stopnje;
Publication date in ReVIS:11.10.2019
Views:2497
Downloads:113
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Licences

License:CC BY-NC-ND 4.0, Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Link:http://creativecommons.org/licenses/by-nc-nd/4.0/
Description:The most restrictive Creative Commons license. This only allows people to download and share the work for no commercial gain and for no other purposes.
Licensing start date:11.10.2019

Secondary language

Language:English
Abstract:Nowadays is almost hard to find a specific type of industry or company, which one does not use sophisticated automated production lines at their production site. This cutting edge automated process systems for their logic and supervision use high tech computer systems which one dictates machine’s behaviour, and also collects and manage all of the data that can be monitored out of the production line. However, at first we need to find an appropriate way to introduce this automated process system to our production site. Because of complexity and due to the fact that this kind of computerized system has high indirect impact on product safety, we have to obtain high standards and regulatory requirements. In this thesis, I discussed the standardized approach of introducing IT part of the automated process system and what it takes to be compliant with legislative and regulatory requirements or good manufacturing practice.
Keywords:production, automated, process system, GMP, GAMP, FDA


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