Method Transfer

Method transfer is a regulatory requirement that is performed between two sites. It is a documented process to verify a certain laboratory’s capability of performing the analytical testing method’s intended use. Method transfers are performed for validated methods for which complete analytical methods and validation data are available.

Method transfer between laboratories and different company sites is needed throughout all pharmaceutical testing. Results have to be consistent throughout all testing being performed no matter where the testing takes place. For results to be considered valid all methods and test plans must be validated. As an example transferring a method from research and development to the quality group for a new a new product that will shortly be produced in manufacturing. It is important to properly have all acceptance criteria developed. After bringing the new method to your lab criteria on validating the method to ensure that it will work as planned must be determined. Once the new method is transferred to the new laboratory for testing all personnel that will be executing the method must be trained in the procedure.

Written By: Daniel Gabrault, Consultant

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