In our final installment of the nitrosamine podcast series, Dr. Teasdale concludes the topic discussing future regulatory guidance relative to nitrosamines and other mutagenic impurities.
The Stages of Method Lifecycle Management
Methods with greater agility, robustness, and capacity for change can help reduce regulatory burden, failure risk, and costs. Discover the stages, concepts, and terms that define lifecycle management, then explore them in depth below.
In part two of The Nitrosamine Crisis, Dr. Teasdale talks about the challenges in nitrosamine testing and provides advice on facilitating accurate quantitation.
In part one of a 3-part series on the Nitrosamine crisis, Dr. Andrew Teasdale of AstraZeneca discusses regulatory expectations, reporting requirements, and minimizing risk relative to solvent contamination.
Controlling risks that compromise analytical method performance is an important aspect of Method Lifecycle Management (MLCM). MLCM is an approach to method management that ensures methods are fit-for-purpose throughout their lifetime.
All successful quantitative LC-MS assays have something in common: high selectivity to accurately detect and identify analytes of interest, high sensitivity to precisely quantify the analytes at very low concentrations, and high reproducibility to ensure that the results can be trusted.
Sample handling and preparation can have a substantial effect on an analytical method’s variability and data quality. It is important to consider and address the risks associated with sample preparation as part of the method development process.
In our first episode, host Greg Martin of Complectors Consulting talks with Dr. Phil Borman of GSK about the advantages and influences of method lifecycle management including analytical quality by design, risk assessment tools, ICH guidances, and opportunities to kick off the approach in your organization.
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.