Quality Featured Articles

  1. What Is Pre-Use, Post-Sterilization Integrity Testing (PUPSIT)? 7/20/2026

    Sterile filter integrity testing helps confirm performance, reduce risk, and support stronger processing controls as global regulatory guidance increasingly emphasizes PUPSIT where feasible.

  2. Good AI Practice In GxP: 4 Implications Of FDA/EMA's Joint AI Principles 7/17/2026

    See how quality, validation, and IT teams can prepare for the next generation of AI governance in regulated manufacturing. 

  3. Connecting GxP Systems Without Compromising Compliance 7/17/2026

    Discover how connected, purpose-built systems help quality, IT, and operations teams improve collaboration while maintaining compliance across every integration. 

  4. 7 Facilities Pilot PreCheck for Faster Approval 7/13/2026

    A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced.

  5. Transforming Computer System Validation In The Life Sciences Industry 7/10/2026

    Regulators acknowledge how traditional CSV methods fail to meet modern demands for speed and flexibility. The scene is changing in favor of smarter, leaner validation.

  6. How Inline Checkweighing Optimizes GLP-1 Vial And Pen Assembly 7/2/2026

    Learn how inline checkweighing helps manufacturers scale GLP-1 vial and pen production while maintaining dosing accuracy, maximizing throughput, and supporting regulatory compliance.

  7. A Scalable Analytical Method For Quality-Driven AAV Characterization 7/1/2026

    AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.

  8. Step Into The Future Of Chromatography Automation 7/1/2026

    As downstream processing grows more connected and complex, chromatography remains a key automation challenge. See how greater flexibility and stronger control are shaping more practical workflows.

  9. Inside Chugai's Digital Infrastructure Strategy 6/29/2026

    When a facility is fully automated and designed for manufacturing flexibility, it needs a digital infrastructure that pulls the systems together, reports data accurately and efficiently, and recognizes areas for continuous improvement.

  10. Q&A: From Trial-And-Error To Predictive Protein Production 6/26/2026

    Speed in protein production starts with better inputs and stronger process analytics. Learn how a three-part strategy helps teams reduce rework and move from guesswork to predictable outcomes.