Dear colleagues -
the FDA published several discussion papers on the use of AI in pharmaceutical development and manufacturing. The one on manufacturing is enclosed here.
The feedback questions the FDA included in the paper are as follows:
1. What types of AI applications do you envision being used in pharmaceutical
manufacturing?
2. Are there additional aspects of the current regulatory framework (e.g., aspects not
listed above) that may affect the implementation of AI in drug manufacturing and
should be considered by FDA?
3. Would guidance in the area of AI in drug manufacturing be beneficial? If so, what
aspects of AI technology should be considered?
4. What are the necessary elements for a manufacturer to implement AI-based models
in a CGMP environment?
5. What are common practices for validating and maintaining self-learning AI
models and what steps need to be considered to establish best practices?
6. What are the necessary mechanisms for managing the data used to generate AI
models in pharmaceutical manufacturing?
7. Are there other aspects of implementing models (including AI-based models) for
pharmaceutical manufacturing where further guidance would be helpful?
8. Are there aspects of the application of AI in pharmaceutical manufacturing not
covered in this document that FDA should consider?
I would be interested in everybody's opinion and see how AAPS can be helpful in advancing this dialog.
Tina
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Tina Morris Ph.D.
Executive Director
AAPS
Arlington VA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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