Validation, Commissioning & Design Featured Articles

  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. Why Cloud Migration Is The Key To Business Agility 5/31/2026

    Discover how transitioning to cloud-native architectures drives business agility in biopharma, reducing infrastructure costs, minimizing downtime, and accelerating time to market for novel therapies.

  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. Simulating PUPSIT Or Gas Purges In Bacterial Challenge Tests 5/22/2026

    Managing PUPSIT‑related risks is a critical part of contamination control. Learn how bacterial retention studies, wetting fluids, and downstream practices influence sterility assurance.

  6. Product-Wet Integrity Testing: Risk-Based Strategies 5/22/2026

    When standard water‑based integrity testing falls short, product‑wet approaches can offer a more representative alternative. Learn how risk‑based strategies are used to establish reliable test limits.

  7. Why Emerging Drug Developers Can't Afford To Delay Analytical Development 5/21/2026

    Rushing early pharma development by neglecting quality and analytical frameworks risks regulatory failures, clinical holds, and expensive rework.

  8. 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.

  9. Which X-Ray, Metal Detector, Or Checkweigher Is Right For Your Industry? 5/18/2026

    Navigate the complexities of pharmaceutical safety with a guide to tailored inspection systems. Match the right technology to your specific product format for total compliance and quality.

  10. It's Time To Leave Paper Behind For Digital Visual Inspection Management 5/13/2026

    Manual records create unnecessary compliance risks. Learn how digital systems provide the automated version control and traceability required to meet modern regulatory expectations and audits.