210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield

Let's Combinate - Drugs + Devices

As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the promise and the challenges of applying intelligent systems in regulated environments.

Key topics covered:

- Current applications of AI in GMP, including CAPA and deviation management

- The role of validation and why algorithmic opacity poses regulatory challenges

- How Process Analytical Technology (PAT) enables real-time release decisions

- The importance of Design of Experiments (DOE) for process optimization

Continuous manufacturing and how yield can signal process performance

Chapters

00:00 Introduction to AI in Pharma

00:40 Current Applications of AI in GMP

02:32 Challenges and Validation in AI

03:22 Process Analytical Technology (PAT)

09:50 Design of Experiments (DOE) in Pharma

13:27 Continuous Manufacturing Explained

15:40 Yield Calculation in Manufacturing

22:12 Conclusion and Contact Information

Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.