FDA is cautioning firms to pay close attention to analytical method development early in the product lifecycle to avoid the problems the agency is seeing during application review stemming from poorly validated methods.
Early attention to method design and validation is particularly critical for biological products, as the inherent variability in many of the methods employed and a lack of available standards and guidance compound the risk of problems surfacing in the later stages of product development.
At a PDA workshop on analytical methods development and validation held in Bethesda, Maryland in June, Center for Biologics Evaluation and Research (CBER) Deputy Division Director and Lab Chief Rajesh Gupta reviewed the specific methods issues that FDA is concerned about and where firms have fallen short of the mark with costly consequences.
Gupta is a leading expert at FDA in analytical methods and trains CBER CMC reviewers on what to look for in their methods reviews. The presentation at the workshop was based on his in-house training materials and, as such, represents the agency’s current thinking on the issues that warrant close industry consideration.
Gupta emphasized that “paying enough attention early” to analytical methods “pays dividends later. In my experience, method design is one area where the potential is big and not much attention is paid.”
In his presentation, the CBER official addressed the design and lifecycle of analytical methods, method validation parameters and comparability and equivalency studies. He delineated agency expectations and the deficiencies they are seeing in applications regarding each of the method parameters.
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