Manufacturing Intelligence Episode 4: Cleanroom Digital Twins

Panelists on the PharmTech AI Pulse Check weigh a December AI playbook, EMA/MHRA moves, PCCP accountability gaps, and MCP-ready regulatory guidance.

The PharmTech AI Pulse Check panel discusses why MHRA and FDA oversight of pharma AI continues past go-live, and who validates the regulators' own AI.

USP data show fewer US drug shortages but longer ones, averaging 5+ years. Drug shortages are an incentive problem, not a manufacturing mystery.

Almac Clinical Services’ clinical supply strategy won the 2026 CPHI Award for Supply Chain Excellence. Nishma Patel, supply chain solutions manager, explains the benefits and challenges of the company’s just-in-time manufacturing solution.

Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory teams can build defensible, inspection-ready AI practices.

Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.

The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.

Manish Baviskar, Hubot CDMO, on ALCOA++ data integrity, model version change control, continuous monitoring, and human sign-off.