Challenges of Analytical Method Transfer in the Pharmaceutical Industry

The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method between laboratories will be required. This process is designed to verify that a given laboratory is capable of performing a test method for its intended purpose. This can be performed either internally (at the same company), or, with the on-going increasing trend in outsourcing, to an external Contract Research or Development organisation (CRO or CDO). Introduction Very often, the analytical method transfer can be underestimated in terms of its relative importance to the continued success of a drug-development program. The execution of the process needs to be very carefully planned, and a full review of all aspects of the method history (including the original development and validation) and any previous issues that may have been encountered. 

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