This workstream explores opportunities to accelerate the implementation of lifecycle management changes by defining best practices for validation.
No standard industry approach for validating common product lifecycle management changes
A lack of a common validation approach has resulted in variability in internal and regulatory expectations. As a result, the most conservative validation strategy is often employed and post-approval changes can take 5-7 years to implement globally. Validation strategies are linked to concepts such as like-for-like or functionally equivalent changes, but no standard definitions of these concepts exist.
Developing best practice guidance to reduce the validation burden and drive consistency
More standardized, consistent validation practice will reduce the operational burden and minimize unnecessary validation effort. It will increase the likelihood of regulators accepting proposed support packages without the need for additional data. Sharing best practices and internal standards for common lifecycle management changes and creating industry-aligned standards and guidance will reduce the validation burden and drive consistency in the level of documentation needed to support validation strategies.
Lifecycle Management deliverables
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