Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework
by:Dora Kourti, PhD
The Role of Models in Quality by Design (QbD) was one of the topics chosen for Points to Consider by the International Conference for Harmonization (ICH), as material relevant to the implementation of ICH Q8(R2), Q9 and Q10. The QbD framework for drug development and manufacturing is a science and risk based approach that begins with predefined objectives for meeting the desired clinical performance and emphasizes product and process understanding and process control. In the QbD framework, mathematical models can be utilized at every stage of product development and manufacturing. Models have been implemented in pharmaceutical industry for developing and controlling processes and have appeared in regulatory submissions. Models can also be indispensable for the implementation of continuous manufacturing processes. Overall, application of models throughout a product’s life cycle from development through manufacturing can enhance process and product understanding.
This Pharmaceutical Engineering on-line exclusive provides points for consideration for model building and utilization in the regulated pharmaceutical industry. It illustrates how models can play a role in the Quality by Design (QbD) framework, outlines the steps for model development, illustrates how model information can be utilized as a part of the control strategy and provides points to consider for a model’s lifecycle in a regulated environment taking into account the impact of the model according to ICH Quality Implementation Working Group points to Consider (R2), published in December 2011.
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