Analytical Method Transfers – Best Practices and Challenges
B M Rao,
Vice President & Head – ASAT & CQC,
Dr Reddy's Laboratories
Analytical method transfers
(AMTs) are typically performed as a precursor to a critical step in the
drug-development timeline, such as bringing on a new manufacturing facility,
release testing of clinical or commercial material, or initiating stability
studies at a quality-control laboratory. AMTs document that a new internal or
external testing laboratory is qualified on the previously validated analytical
method in order to generate current Good Manufacturing Practices
(cGMP)-compliant data. Analytical method transfers are a regulatory requirement. A
successful AMT requires accurate communication between the transferring and
receiving laboratories and a clear plan with defined roles and
responsibilities. But the most important takeaway is to never treat an AMT as a
checkbox routine. Differences in
instrumentation, techniques, procedures and even interpretations of an
analytical procedure can lead to preventable AMT failures. This topic
extensively covers some of the best practices to be adopted during AMTs and how
to address the key challenges.
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