Featured Pharma Online Editorial

1. Solving The Top 3 Pharma Packaging/Manufacturing Issues 2/5/2026

   Regulatory changes, space/footprint constraints and expanding automation garnered more votes than the other challenges. Let’s explore these challenges, and see how the industry is tackling them as we move into 2026.

2. New ISPE Framework Targets Uncertainty In Pharma's AI Deployment 1/29/2026

   International Society for Pharmaceutical Engineering members developed the guide to offer a risk-based framework for evaluating, implementing, and maintaining AI systems.

3. 5 FDA Approval Categories In 2025 1/15/2026

   With less drugs approved in 2025, it is interesting to see what drugs made it through and if any categories of treatment emerged.

4. A 2025 Pharma Look Back and Look Forward: Editor Style 1/7/2026

   Though I still have a great deal to learn about the pharmaceutical industry, I am surrounded by a warm and incredibly bright cast of editors that I gain knowledge from every day.

5. 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.

6. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

   This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

7. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

   MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

8. 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.

9. FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs 12/11/2025

   The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

10. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.