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What does it take to standardise an entire industry, and keep pace with AI, cloud, and digital transformation?

This week on Making It in Manufacturing, we feature Thana Subramanian, GAMP Global Steering Committee Co-Chair, with over 32 years of experience in idustry, with 25 years as an ISPE member and 15 years as part of the GAMP CoP.

In this episode, Thana covers:

- The history and purpose of ISPE and its role in advancing pharmaceutical manufacturing

- How GAMP evolved alongside regulatory bodies like the FDA and EMA

- The benefits of ISPE membership, from networking to access to global best practices

- The origins and evolution of GAMP, from early guidance to modern AI-driven systems

- The objectives and key themes of the latest GAMP UK Conference, including AI, digital validation, and data integrity

If you’re working in pharma, biotech, or advanced manufacturing, this episode gives you a clear lens into how global standards are shaped — and where the industry is heading next.

Be sure to check out the full episode.

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Thana Subramanian

GAMP Global Steering Committee Co-Chair

LinkedIn: https://www.linkedin.com/in/thanasubramanian/

Thomas McMann

Director - Contracts Division

LinkedIn: https://www.linkedin.com/in/thomas-mcmann-05540a10b/

Timestamps:

00:27 ISPE History

02:33 GAMP New Good Practice Guide (GxP Process Control Systems) Third Edition

07:32 Benefits of ISPE and GAMP

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