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Hur arbetar ni med validering?
– Valideringsarbetet omfattar mer eller mindre alla aktiviteter inom produktionen. För vissa delar av produktionsprocessen kan kvaliteten inte säkerställas utan att processen valideras, det vill säga man kan inte genom analys fastställa om rätt kvalitet uppnåtts. Bioinvent har en särskild grupp som enbart arbetar med valideringsfrågor. Denna grupp förstärks kompetensmässigt genom att personer som normalt arbetar på andra avdelningar inom företaget deltar i valideringsprojekt. Vårt företag tillverkar endast prövningsläkemedel som används i klinisk utveckling. Detta kan leda till en diskussion om hur omfattande valideringen skall vara inför olika kliniska faser. Inför valideringen av ett objekt eller en metod uppstår ofta en diskussion om omfattning och upplägg.
– Vi är många företag som ställs inför precis samma problem. Detta innebär att vi alla antagligen ”uppfinner hjulet på nytt”. Bättre guidelines skulle kanske underlätta arbetet och förbättra valideringsarbetet. Det finns diskussionsforum på internet som kan rådfrågas, det vore önskvärt att dessa forum utvecklades ytterligare.
– Valideringsarbetet omfattar mer eller mindre alla aktiviteter inom produktionen. För vissa delar av produktionsprocessen kan kvaliteten inte säkerställas utan att processen valideras, det vill säga man kan inte genom analys fastställa om rätt kvalitet uppnåtts. Bioinvent har en särskild grupp som enbart arbetar med valideringsfrågor. Denna grupp förstärks kompetensmässigt genom att personer som normalt arbetar på andra avdelningar inom företaget deltar i valideringsprojekt. Vårt företag tillverkar endast prövningsläkemedel som används i klinisk utveckling. Detta kan leda till en diskussion om hur omfattande valideringen skall vara inför olika kliniska faser. Inför valideringen av ett objekt eller en metod uppstår ofta en diskussion om omfattning och upplägg.
– Vi är många företag som ställs inför precis samma problem. Detta innebär att vi alla antagligen ”uppfinner hjulet på nytt”. Bättre guidelines skulle kanske underlätta arbetet och förbättra valideringsarbetet. Det finns diskussionsforum på internet som kan rådfrågas, det vore önskvärt att dessa forum utvecklades ytterligare.
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