How to Maintain Suitable Analytical Test Methods: Tools for Ensuring a Validation Continuum

Many industry professionals know that analytical testing for biopharmaceuticals for all raw materials, production in-process stages, and final containers must be validated, and they generally understand how this can be achieved. Many of us even understand the basic concepts of laboratory compliance and production process quality. However, how exactly are analytical test method performance and process robustness related and how do they depend on each other? Furthermore, how do we monitor and maintain the accuracy and reliability of analytical methods long after validation completion to ensure the suitability of these methods for measuring process quality?

Most monitoring and maintenance activities should be controlled within a validation master plan (VMP) program. A good VMP in quality control (QC) should include not only detailed strategies and timelines for initial validation activities but also tools for maintaining compliance for years to come. The lifecycle of an analytical method should be captured from beginning to end. The beginning can be defined to lie somewhere between early-stage and finished method development, whereas the end is usually the replacement of one method with a better one. Currently, relatively little guidance exists for maintaining compliance and validity for analytical testing. This article focuses on how to run a practical program for analytical method maintenance (AMM) and how to ultimately integrate it into the production process. Detailed suggestions for analytical method development (AMD), analytical method validation (AMV), and analytical method transfer (AMT) as well as regulatory submissions are discussed elsewhere.1-7

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