Press Room

Webinar - AMLM: the perks of method performance verification in pharmaceutical quality framework

Thursday, October 22, 2020 - 16:00
Thursday, October 22, 2020 - 16:00
Location: online

Thursday, October 22nd, 2020 | 12 PM (EDT), 4 PM (BST), 5 PM (CEST)


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Lúcia Volta e Sousa - Analytical Chemist, R&D Analytical Development
Nuno Matos - Director, Quality System Management


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.


In this webinar you’ll learn:

  • Analytical Method Lifecycle Management

  • Method Performance verification program

  • ICH Q14 and Q12

  • USP


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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at  


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