Quality Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. USP Draft Chapters On CCS: What You Need To Know 5/12/2026

    Learn why it's important to stay aligned with evolving Annex 1 expectations to support sterility assurance, regulatory compliance, and patient safety across sterile drug manufacturing operations.

  10. USP <788> Revisions And Why Packaging Matters More Than Ever 5/12/2026

    Prepare for the upcoming USP <788> revisions by strengthening your particulate control strategy to support regulatory compliance, product quality, and patient safety across injectable drug products.