GUEST COLUMNISTS

• Why FAT Should Confirm Alignment, Not Reveal Its Absence

  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.

• What Reliance, Annex 1, And AI Mean For The Future Of GMP

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

• Applying Contamination Control By Design: A Practical Guide For CDMOs

  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.

• Rethinking CQV In A Digital, Agile Manufacturing Landscape

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

• Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

  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.

• A Multi-Agent Audit Intelligence Framework For CDMO Quality Oversight

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

• Why Contamination Control By Design Should Matter To Your CDMO

  EU GMP Annex 1 mandates a documented contamination control strategy, and FDA expectations are substantively equivalent. Let's look at why CDMOs are disproportionately exposed.

• Closing The MES Value Gap: Why Technology Isn't The Problem

  Manufacturing execution system (MES) technical maturity is rising, but adoption across manufacturing sites is uneven. Organizational readiness may hold the key.