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Regulatory considerations for model-based control strategies

Consuelo Vega

Dear Regulatory Science Group, 

Advanced control strategies such as model predictive control are gaining significant attention for CM. In order to develop this kind of strategies, models need to be obtained.

- Can you share your knowledge on what regulatory considerations for model (mechanistic, data-driven or hybrid) development and or  control strategy development you have encountered when submitting to regulatory agencies? 

- In this interesting FDA article, only ICH Points to Consider for model development, validation and maintenance is mentioned but is there any other source of information?

I believe there is an important gap in knowledge in this subject which can affect model development specially in the Academy. 

Have a good day,

Thank you for your attention.

 

  • Dear Consuelo,

    Thank you for your question. It would be helpful if you could provide more details. For example:

    • Is your intended MPC for Drug Substance or Drug Product?
    • Will the MPC control a single unit operation or the entire process?
    • What is the purpose of your MPC approach? For instance, does it control a unit operation that directly impacts the final product quality (such as tuning the compression force of a tablet press), or does it manage a less quality-sensitive criterion (like the yield of a reactor)?

    The paper you cited is not related to model V&V. There are numerous resources available for your consideration, but it depends on the answers to the above questions.

    Additionally, you mentioned “control strategy development.” Please note that the regulatory definition of “Control Strategy” (refer to ICH Q8) differs from the term as used in technical process control and automation (e.g., ISA and IEEE definitions).