Method Lifecycle Management Strategies Pave the Way for Greater Procedure Understanding and Fewer Transfer Failures

Posted by Stephanie Harden, PhD on April 24, 2020


In recent years, the increased number of method transfer failures has led to greater transfer scrutiny by industry and regulators. And for good reason. Simple paper transfers between sending and receiving units and provision of ambiguous information are widely regarded as insufficient. These outdated practices are now being superseded by more proactive approaches to support successful method transfer, including the provision of method transfer packages and improved lab-to-lab communication1. Indeed, it was a decade ago that Nethercote, et al2 described the benefits of Quality-by-Design based method development with the goal of creating more robust analytical procedures. Despite these advances, however, there are still situations where methods that come into the receiving lab are poorly understood, or insufficient information is available. Even with the implementation of pharmacopoeial methods, or well-understood robust methods, predicting problems can be challenging, and many only show up over time.

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Modern Perspectives on Method Development: An Interview with Dr. Fadi Alkhateeb

Posted by Dr. Fadi Alkhateeb on March 9, 2020

Dr. Fadi Alkhateeb of Waters Corporation discusses his recent method development work.

What does it mean to develop a good LC method?

With Method Lifecycle Management (MLCM) we focus not only on the quality of the analytical method but also on the quality of the reportable result. The goal is to generate quality data across the life of a method. To achieve this, method development begins with an Analytical Target Profile (ATP) in which performance objectives are defined in terms of accuracy and precision, independent of the analytical technology chosen.  The ATP is linked to the Critical Quality Attributes (CQA) of the drug product and the Critical Process Parameters (CPP) of the manufacturing process.  The traditional method development goals of resolution and peak shape are critical method parameters, but what defines a good method under MLCM principles is one that achieves the accuracy and precision goals specified in the ATP. This leads to a quality reportable result throughout the method’s life. 

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Modern Tools and Risk-Based Method Development Strategies Pave the Way for a New Generation of Analytical Methods

Posted by Sherri L. Naughton on February 17, 2020


In the pharmaceutical industry there’s a shift and it’s changing the way we think about and develop analytical methods. Change can be uncomfortable, but when the driving forces are to ensure data quality, make better decisions and improve patient outcomes, how can we resist?

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