Sedan några år arbetar du även inom kärnkraftsindustrin. Vad kan kärnkraftsindustrin lära sig av läkemedelsbranschen?
– Eftersom läkemedelsbran-schen är betydligt äldre har valideringsmetoderna hunnit utvecklats under en längre period. Varje gång det har hänt något, som att människor har skadats av ett läkemedel, ökar kraven på verksamheten och därmed behovet av en strukturerad validering.
| Vill du läsa mer om validering? Under påskhelgen skriver vi om bland annat viruskontroll och annat nyttigt om valideringsprocessen. Det kommer även att finnas intervjuer med personal från läkemedelsbolag som arbetar med just validering. |
Hur arbetar du med validering för läkemedelsbranschen idag?
– Jag jobbar mycket med anläggningsprojekt. Det handlar om att ha ett strukturerat arbetssätt för att ställa krav på tillverkningsanläggningen – vad som ska kravställas och hur man bryter ner kraven från anläggningsnivå ned till komponenter – samt ta fram lämpliga verifieringsmetoder. Man måste kunna påvisa att anläggningen klarar att utföra sin uppgift, som till exempel att tillverka ett specifikt preparat. Jag jobbar med att etablera kvalitetsrutiner och valideringsstrategier hos våra kunder som bidrar till deras projektverksamhet och gör det möjligt att hålla anläggningen validerad över tiden.
Hur kan valideringen i läkemedelsbranschen förbättras?
– Det är viktigt att kvalitetsåtgärderna är adekvata och verkligen har en effekt. Man måste rationalisera och bara ta med de steg som är relevanta. Till exempel är god konfigurationshantering, det vill säga att hantera utveckling och förändring av sammansatta system och produkter under hela deras livscykel, en förutsättning för en effektiv validering. Validering är ganska kostsamt, men det är samtidigt den enda garanten för tillgänglighet och i slutänden vinst för företagen, sett över tiden. Men det gäller att man validerar rätt saker och skalar bort det onödiga. Det är något som både läkemedels- och kärnkraftsbranschen kan bli bättre på.
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