Pre-requisites for ICH Q12 implementation (product and process understanding, Quality Risk Management, PQS). Key concepts to identify Established Conditions: How Control Strategy and development approach influence the extent of ECs Main decision criteria to implement an ICH Q12 approach.
QbD and Control strategy – still learning!
Jennifer HALLEY, UCB
QbD process flow with do’s and don’ts! IQ Consortium on CQA’s and PCS – key takeaways from questionnaires and discussions Control Strategy is the top of the Pyramid – there are a lot of bricks holding it up!
Establishment of an appropriate control strategy for biotechnological products in accordance with ICH Q12
Hervé BROLY, Merck
The presentation will focus on the Merck-Serono approach for establishing an appropriate control strategy for biotechnological products. It will address the assessment of criticality of quality attributes, how to rank and select the process parameters to ensure an efficient control of the manufacturing process, and how to establish the control strategy from process design and process characterization data. Finally the presentation will discuss the application of established conditions as described in ICHQ12.
Control Strategies established and maintained using data-driven risk management
An efficient Quality Risk Management approach is key to establish the link from the Quality Target Product Profile to the Critical Quality Attributes and identify the critical process parameters. This presentation will illustrate how a data-driven risk assessment tool can be applied throughout the product lifecycle to: - In development: Identify critical parameters and assess sufficiency of control strategies - Post-approval: Evaluate the impact of suggested changes ensuring the process is maintained in control
How to deal with the implementation of post-approval CMC changes across the product lifecycle?
Thierry GASTINEAU, SANOFI PASTEUR
The management of CMC Post Approval Changes currently represents a huge and complex burden of activities both for the Pharmaceutical Industry as well as for Regulators. This hampers the worldwide timely and equitable access of pharmaceutical products of the highest and latest quality standards. The recent release of ICH Q12 represents a major milestone for dramatically improving this situation. In fact, ICH Q12 is the natural continuation of ICH Q9 (on quality risk management) and ICH Q10 (on the Pharmaceutical Quality System) which were published more than 10 years ago. The PDA Association has formed a “One-Voice-of-Quality” group gathering the Chief Quality Officers of 25 well-known multi-national pharmaceutical companies. This group has articulated the above 3 ICH guidelines in such a way that it allows to understand and fully realize the benefit of those guidelines in order to facilitate the implementation of lot of PACs across the product lifecycle. The presentation will aim at presenting the work done by the PDA 1VQ as well as addressing the additional challenges to still overcome.
Session Q&A avec les intervenants. Retour d'expériences et partage autour des bonnes pratiques