Opportunities for Lean Stability Strategies

Lean stability strategies have evolved since the 1st ICH guidances were introduced and employ science and risk-based approaches. These strategies are fit-for purpose and attempt to minimize non value-added tests and pull points. Lean strategies include anything that reduces cost, avoids costs or reduces lead-time. These strategies can be applied at all stages of development and to all product types. This paper will briefly introduce lean stability strategies and tools but will focus on recent case studies and share where industry has succeeded and failed in global regulatory filings (clinical submissions, marketing applications, and post-approval). Examples of non-regulatory cost-saving initiatives will also be shared.