Featured Pharma Online Editorial

1. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

   This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

2. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

   In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

3. What Reliance, Annex 1, And AI Mean For The Future Of GMP 5/29/2026

   EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

4. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

   This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

5. Navigating Rough Pharma Seas With Collaboration 5/22/2026

   Facing geopolitical, regulatory, and operational complexity, pharma leaders are rethinking supply chains, embracing AI, and simplifying processes. Progress hinges on cross-industry collaboration and shared standards to build resilient, efficient systems.

6. Rethinking CQV In A Digital, Agile Manufacturing Landscape 5/21/2026

   While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

7. Will FDA's One-Day Inspection Pilot Stand The Test Of Time? 5/19/2026

   FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

8. A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight 5/18/2026

   A Takeda quality executive demonstrates how a team of AI agents uses synthetic data to provide decision support ahead of CDMO audits.

9. Why Isolators Do Not Automatically Ensure Annex 1 Compliance 5/12/2026

   Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.

10. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

    Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.