Analytical Method Lifecycle Management (AMLM) principles require a holistic perspective where method robustness is considered together with process and product variability. AMLM views all method related activities as a continuum and interrelated multi-step process, where knowledge and risk management are the key enablers.
This includes three stages, Method design (Stage 1), qualification (Stage 2) and Performance Verification (Stage 3). All knowledge gathered in Stage 1 and 2 allow an effective definition of the Analytical Control Strategy (ACS), that provides directly the performance parameters that can be continuously monitored on Stage 3. In contrast to the first two stages, Stage 3 offers the possibility of an enhanced data set to collect, analyze and evaluate method performance. This promotes a continuous method evaluation, ensuring it remains fit for the intended purpose or, if not, supports the corrective actions required for method improvement. Moreover, this monitoring program should be aligned with the Quality Management System (QMS) in place, since it includes an efficient change control and deviation management system.
With this webinar an overview of AMLM Stage 3 will be presented, including its implications, advantages and case studies, and its capturing within the current QMS. Additionally, regulatory and industry initiatives that mark the evolution of these concepts and capture the current and future expectation of pharmaceutical framework will be highlighted.
Learning objectives:
Analytical Method Lifecycle Management
Method Performance verification program
ICH Q14 and Q12
USP <1220>
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