Featured Pharma Online Editorial

1. From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations 4/1/2026

   The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.

2. Where Contamination Control Really Breaks Down In Practice 3/13/2026

   Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

3. Trends In FDA FY 2025 Warning Letters 3/13/2026

   The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

4. Raising The Bar In Radiopharmaceutical Manufacturing 3/12/2026

   Ratio Therapeutics chief commercial and manufacturing officer, Scott Holbrook, joined me to discuss how his team at Ratio Therapeutics is tackling the challenges of radiopharmaceutical manufacturing.

5. At Base Camp: Lilly's Manufacturing Capacity Journey 2/13/2026

   In 2025 alone, Lilly announced plans to build new facilities in Texas, Alabama, Virginia and Pennsylvania in addition to facility expansions in Indiana, Wisconsin and Puerto Rico.

6. The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality 2/13/2026

   The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

7. Top 7 AI Lessons Learned 12/23/2025

   As an icebreaker to start the panel, Teresa Minero from LifeBee asked each presenter to share their top recommendations and major issues to avoid with AI.

8. An AI Use Case in Pharma Process Optimization 12/18/2025

   Recordati Ireland’s production coordinator Ross Fitzgerald took attendees through his team’s AI journey, from identifying the problem to using AI data analytics to find a solution.

9. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

   Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

10. It's Copy/Paste In Fleet Management Manufacturing 12/11/2025

    Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.”  In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying the copy/paste action to standardized, decentralized facilities.