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.

• What To Do About Process Drift In Your Biosimilar's Reference Product

  Biosimilar development often reveals quality drifts in certain lots of the reference biologic. In most cases, quality changes are noncritical, but some drifts can impact CQAs.

• Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit

  The missing link between data generation and unleashing it to power automation often lies in well-governed cloud infrastructure.

• 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.