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Title:NOV PRISTOP K VALIDACIJI PROCESOV
Authors:ID Držečnik, Tanja (Author)
ID Kravanja, Zdravko (Mentor) More about this mentor... New window
ID Novak-Pintarič, Zorka (Comentor)
ID Grošelj, Janez (Comentor)
Files:URL UNI_Drzecnik_Tanja_2012.pdf (2,22 MB)
MD5: 4AC385C532E81CB6585853E102A41C2C
PID: 20.500.12556/dkum/8e7df234-f3a6-4a0d-9cce-47d973f8dd82
 
Language:Slovenian
Work type:Undergraduate thesis
Typology:2.11 - Undergraduate Thesis
Organization:FKKT - Faculty of Chemistry and Chemical Engineering
Abstract:V farmacevtski industriji obstajajo stroge regulatorne zahteve glede kakovosti izdelkov, ki jih podjetja izdelujejo za paciente. Eden od načinov dokazovanja, da je izdelek ustrezne kakovosti, je procesna validacija. Procesna validacija je dokument, ki dokazuje, da je določen proces sposoben dosledno proizvajati produkte zahtevane kakovosti. Do nedavnega so procesne validacije zajemale eno stopnjo dela – izdelek je bilo po razvojni fazi potrebno preizkusiti s tremi validacijskim serijami in ovrednotiti rezultate. Ustrezni rezultati so zagotavljali izdelek zahtevane kakovosti. Januarja 2011 je Agencija za hrano in zdravila iz ZDA (FDA) objavila dokument, ki vpeljuje nov pristop k procesnim validacijam. Od dosedanjega se razlikuje predvsem v učinkovitejšem nadzoru izdelka skozi njegov celoten življenjski cikel. V diplomski nalogi smo uvedli nov pristop k procesnim validacijam na izdelku filmsko obloženih tablet z aktivnima učinkovinama amoksicilinom in klavulansko kislino. Izdelek je v zreli fazi razvoja, vendar smo ga morali zaradi uvedbe novega pristopa in optimizacije procesa znova validirati. V sklopu novega pristopa smo načrtovali proces, izvedli procesno kvalifikacijo in izdelali plan kontrole, ki bo zagotavljal izdelek ustrezne kakovosti ves čas njegovega življenjskega cikla. Pri tem smo natančneje določili in opredelili procesne parametre in atribute kakovosti, ki smo jih med izdelavo validacijskih serij tudi testirali. Rezultati so pokazali, da je naš proces stabilen, izdelek ustrezne kakovosti in da so optimizacije procesa pri nekaterih parametrih še vedno mogoče.
Keywords:procesna validacija, življenjski cikel, tabletiranje, kritični procesni parametri, kritični atributi kakovosti, sposobnost procesa
Place of publishing:Maribor
Publisher:[T. Držečnik]
Year of publishing:2012
PID:20.500.12556/DKUM-39272 New window
UDC:66.01:331(043.2)
COBISS.SI-ID:16716566 New window
NUK URN:URN:SI:UM:DK:XQBJKAVD
Publication date in DKUM:20.12.2012
Views:2984
Downloads:229
Metadata:XML RDF-CHPDL DC-XML DC-RDF
Categories:KTFMB - FKKT
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Secondary language

Language:English
Title:CONTINUOUS IMPROVEMENT OF PROCESS VALIDATION
Abstract:In pharmaceutical industry there are strict regulatory requirements concerning the quality of products manufactured for patients. One way of proving that a product meets the required quality is process validation: a document proving that a process is capable of consistently producing products of the required quality. Until recently, process validation included only one work stage: after the development phase the product had to be tested three validation batches and the results had to be evaluated. Suitable results guaranteed that the product was of the required quality. In January 2011, the U.S. Food, Drug and Administration agency (FDA) published a document that introduced a new approach to process validations. The main difference between the new and the current approach is that the new one provides more effective monitoring of products through their entire life cycles. In this thesis, the new approach to process validation was applied to film-coated tablets, with Amoxicillin and Clavulanic acid as active ingredients. Although the product is in its mature stage of development, the process had to be validated because of required implementation of the new approach and process optimization. The new approach entailed process design, process qualification and control strategy, which would ensure the product had the required quality throughout its life cycle. In doing so, process parameters and quality attributes were identified and defined in greater detail and tested during the production of the validation batches. The results showed that the process was stable, the product was of adequate quality and that for some parameters the process could be further optimized.
Keywords:process validation, life cycle, tableting, critical process parameters, critical quality attributes, capability of process


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