2019 PharmSci 360
As the analytical method journeys, it can transfer across analysts, labs, divisions, companies and continents for deployment in routine use. Maintaining performance of the analytical method during its lifecycle is essential to ensure data quality that drives sound decisions on the safety and efficacy of the pharmaceutical product. Method Lifecycle Management (MLCM) is a holistic approach that encompasses method design, development, validation, transfer, routine use, and retirement. MLCM improves method understanding, facilitates method transfer and leads to fewer out-of-specifications results (OOS).