William E. Weiser - senior director, Global Quality Systems, Pharma Services at Thermo Fisher Scientific explores the factors that make or break a successful compliant method transfer.
Make or break
Method transfer is a vital process in pharmaceutical manufacturing, as scientists transfer methods between instruments that may be in different laboratories, sites or even organisations. However, successful liquid chromatography (LC) analytical method transfer can be a complex undertaking, particularly when transitioning from legacy to modern instrumentation.
Deviations in instrument parameters can lead to difficulties in validating the method on the receiving instrument. Consequently, scientists in pharmaceutical manufacturing laboratories need to fine-tune multiple variables to obtain reproducibility and compliance, which often requires significant time and resource.