What sort of challenges does ensuring lot-to-lot consistency present to IVD companies in their manufacturing processes?
The IVD Directive requires you to formalize your processes to develop and manufacture clinical chemistry reagents to be consistent with reference methods and materials. Previously, each manufacturer was able to produce and test products in accordance with internal systems and consistent with prior lots, but now we also have to have traceability to reference methods and materials. This has reduced the differences between manufacturers’ products and has made it somewhat easier for customers to change chemistry system suppliers, which has been a benefit to Olympus as we gain market share. Lot-to-lot consistency becomes problematic if you have to switch raw materials and have not qualified alternative vendors. We have backup suppliers and make sure that the incoming material is appropriately categorized and characterized, so this is appropriately managed. What role do in-house audits play in their manufacturing processes of IVD companies? Not only does the manufacturing entity have the res
