Contributing Editors

  1. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

  2. 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.

  3. Managing Organic Impurities And Nitrosamines In APIs 6/4/2026

    How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

  4. The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process 6/2/2026

    Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.

  5. CDMO Selection: Start With The Relationship, Not The RFP 6/1/2026

    Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.

  6. 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.

  7. 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.

  8. 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.

  9. Field Notes: Freeing Process Data For Automation At Kivi Bio AI Summit 5/22/2026

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

  10. 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.