The
members of the USP Validation and Verification Expert Panel, working under the
direction of the General Chapters—Physical Analysis Expert Committee, are
posting a Stimuli article to present their current thinking on lifecycle
management of analytical procedures.
The
Expert panel suggests that the traditional approaches to validation, transfer,
and verification should be integrated into the analytical procedure lifecycle
process rather than be viewed as separate entities. This applies the modern
concept of a lifecycle model to analytical procedures. This stimuli article
should be considered as a roadmap for new validation standards that will be
developed and presented over the course of the next couple of years.
Posted by Tim Sandle
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