Course No 16005
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The aim of this two-day course is to provide practical guidance on how QbD principles can be translated and implemented in drug product development. This course will deal among others with the following questions:
The pharmaceutical industry is currently embracing QbD concepts to help improve the robustness of manufacturing processes and to facilitate continuous improvement strategies to enhance product quality and availability throughout a product’s life cycle. QbD ensures product quality and requires process performance characteristics to be scientifically designed to meet specific objectives, not merely empirically derived from the performance of test batches. Key QbD concepts are described in ICH guidelines Q8 Pharmaceutical Development, Q9 Quality Risk Management and Q10 Pharmaceutical Quality System. A new ICH guideline Q12 on Life cycle Management, which is intended to complement existing ICH Q8 to Q11 guidelines, is planned.
Risk- and science-based product development requires the support of structured tools for experimental planning and knowledge management. The documentation of the development work in risk assessments and development reports is a key to efficient compilation of the submission dossier.
Process Analytical Technology (PAT) is a key tool to an effective implementation of QbD as a way to achieve process knowledge and control. Through application of PAT during development and advanced monitoring and control options, process performance can be improved.
Initiatives from regulatory authorities like the recently published draft Annex 17 (EU GMP Guideline) on “Real Time Release Testing” emphasize the advances in the application of PAT, QbD and quality risk management (QRM) principles to pharmaceutical development and manufacturing (including quality control).
This course aims to provide a potential way how to meet current regulatory expectations and realize the Process Design Stage in practice. Special focus is set on the application of an alternate risk assessment approach as a guiding tool that drives drug product development. Another important aspect is adequate reporting and documentation of results that are finally summarized in the submission dossier.
This course is designed for drug product managers and scientists who are responsible for performing or reviewing activities like drug product development, process validation, scale-up and transfer, and CMC dossier preparation.
In addition, QA and regulatory affairs professionals will benefit from this course by gaining an understanding of current CMC trends. This will aid more effective multifunctional discussions on these topics within industry.
Introduction to drug product development – setting the scene