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Dr. Ludwig Huber

GMP for Quality Control and Contract Laboratories

Quality control and related contract laboratories are considered high risk because after testing and approval drug products and APIs are released to the market without further check. That's the reason why FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.

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