Press Room

Webinar - Analytical Quality by Design Road Map

Start
Wednesday, March 15, 2017 - 14:00
End
Wednesday, March 15, 2017 - 17:00
Location: online
Analytical Quality by Design QbD | Hovione

 

 
Speakers
António Ramos - Analytical Chemist
Lúcia Volta e Sousa - PhD Student / Analytical Chemist

There is a current trend in pharmaceutical industry on applying Analytical Quality by Design (AQbD) to method development as a part of analytical method lifecycle. Indeed, there is a considerable interest in enhancing method understanding in order to reduce failures, increase method robustness and reliability through its lifecycle. Reversed Phase-Liquid Chromatography (RP-LC) is the widest technology used in any pharmaceutical analysis so its performance should be widely studied during method development in order to ensure its robustness throughout the entire lifecycle. So, the application of an AQbD approach through a RP-LC method development represents an excellent opportunity to enhance method development activities while turn time into knowledge.

At Hovione, new analytical stepwise methodology based on QbD principles, already used at Hovione for process development, is being developed and has been applied to RP-LC methods development. This involves several steps: from objectives pre-definition; followed by the selection of an appropriate technology; passing through a method understanding process of how potential sources of variability may affect method performance, through structured and scientific-based tools (ex: DoE);  and ends up with a risk mitigation phase, where all sources of variability are reduced and controlled based on method understanding. So, in order for you to understand Hovione's point of view for AQbD application, I invite you to assist this exciting webinar where is presented some case studies in RP-LC, that highlights the application of this new methodology, as well as the newly defined of important AQbD concepts, such as Analytical Target Profile, Method Operable Design Region, Normal Operable Range and Analytical Control Strategy.

Key Learning Objectives:

  • Application of QbD principles to reverse-phase liquid chromatography methods
  • Development strategy to obtained increased reliability and robustness over method's lifecycle
  • Evaluating the relevant QbD elements and establishing their combined performance to reduce failures and costs over method lifecycle

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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 gmp-journal.com  

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