In this episode of the NSF Compliance Podcast, Global Marketing Director Brian Cleary sits down with Dr. Pete Gough, Vice President and Principal Consultant for NSF Life Sciences, to unpack two of the most significant global regulatory shifts impacting the pharmaceutical and biopharma industries today: artificial intelligence (AI) governance and decentralized manufacturing.

Dr. Gough explores how regulatory agencies—including the EU, MHRA, FDA, and international bodies—are racing to develop frameworks for AI oversight in GxP environments. From the EU’s pioneering legislation and Annex 22 guidance, to the UK’s emerging commissions and the FDA’s new AI policy councils, this discussion highlights how regulators are responding to AI’s rapid adoption and the risks associated with dynamic, probabilistic, and generative models in critical GMP applications.

The conversation also dives deep into decentralized manufacturing, a transformative model reshaping how advanced therapies—especially ATMPs and cell & gene therapy products with extremely short shelf lives—can be produced safely and effectively closer to the patient. Dr. Gough details the UK’s world-first implementation of a decentralized manufacturing regulatory framework, the new designation pathway, the role of control sites, decentralized manufacturing master files (DMMFs), and how QPs and manufacturers must adapt to satellite-site oversight and new GMP expectations.

Whether you're a regulatory professional, QA/QC leader, pharma executive, or involved in ATMP, CGT, or advanced manufacturing innovation, this episode provides essential insight into the evolving compliance landscape—and what the future holds for AI-enabled and point-of-care manufacturing models.

Key Topics Covered

Global regulatory trends for AI in pharmaceutical manufacturing

EU Annex 22 and emerging guidance around AI/ML model usage

Risks of bias, model training quality, and required human oversight

UK, EU, and US approaches to AI policy and harmonization

Overview of decentralized manufacturing, modular systems, and point-of-care production

The UK’s first-in-world implementation of decentralized manufacturing legislation

The role of control sites, satellite sites, QPs, and DMMFs

Impacts on ATMP and cell & gene therapy development

Future direction of global harmonization and regulatory frameworks

Learn more about NSF’s pharma biotech expertise:

https://www.nsf.org/life-sciences/pha...

About NSF

Companies all over the world rely on NSF’s expert team of pharma biotech, medical device, IVD, and combination product experts to guide them through the maze of regulations and industry challenges. Our experts can tailor a solution to meet the specific needs of your company. Since 1944, NSF has helped companies deliver life-saving and life-changing medical products to their patients. Find out more on NSF.org.

You can contact our life sciences team by emailing [email protected]

or by visiting: https://www.nsf.org/contact-us