In our second episode, we examine a method lifecycle management approach in monitoring method performance and applying MLCM to address real world issues like nitrosamines (ni-tros-a-mine) in Valsartan.
In Episode 3, Dr. Pauline McGregor discusses how MLCM is applied to the verification and transfer of compendial procedures including the importance of developing, defining, and refining the analytical control strategy.
Dr. Horacio Pappa, Director of the General Chapters Department, Global Science Division at USP, discusses the current regulatory landscape, guidance from USP and ICH, and implications for regulatory strategies relative to method lifecycle management.
Dr. Mark Argentine, Senior Research Advisor of Eli Lilly, discusses the benefits at Analytical Quality by Design, the challenges of identifying impurities and drug degradants, and regulatory and compliance barriers to enhance analytical controls.
In Episode 6, Dr. Phil Nethercote discusses the factors that led to the beginnings of MLCM and QbD in 2004; his early days at GSK and the implementation of MLCM; and how Method Lifecycle Management might evolve.