Featured Pharma Online Editorial

1. Beyond The Plate Count: How To Build A Defensible Environmental Monitoring Trend Review 11/6/2026

   Determining whether a drug manufacturing environment is stable, drifting, or developing a recurring loss-of-control signal requires integrated trend evaluation.

2. What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI 11/4/2026

   The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.

3. The EU Overhauls Pharma Laws: What You Need To Know 11/2/2026

   On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon.

4. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

   FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

5. Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty 10/22/2026

   Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

6. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

   Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

7. The Orange Book's Blind Spot: Process Stability And Capability 10/5/2026

   The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.

8. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

   By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

9. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

   Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

10. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

    The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.