Abstract

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.