Validation, Commissioning & Design 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. Why Spray Drying Is Gaining Attention 7/20/2026

    Facing patent cliffs, pharma companies can leverage spray drying to reformulate complex biologics, enabling non-invasive delivery, boosting patient convenience, and securing new patents.

  3. 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. 

  4. 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. 

  5. Three Keys To E&L Success: Study Design, Partner Selection, And Timing 7/16/2026

    Successful E&L planning starts before testing begins. Aligning study design, partner expertise, and timing helps teams focus on the right risks, avoid surprises, and support stronger development.

  6. Looking Back At USP <86>: Key Changes And Their Impact On Biological Reactivity Testing 7/16/2026

    USP <86> introduces validated recombinant alternatives for endotoxin testing, supporting animal-free QC. Learn key validation, comparability, and regulatory considerations.

  7. Preparing For Future Changes To USP <87>: What Customers Should Know Today 7/16/2026

    Upcoming updates to a key bioreactivity standard could impact qualification, supplier oversight, and testing. Learn how in vitro and risk-based approaches may shape future compliance.

  8. 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.

  9. Factory Acceptance Testing (FAT): Pre-Shipment Quality Verification Guide 7/6/2026

    Quality control begins long before installation. Discover how pre-shipment testing mitigates risk, ensures specification compliance, and streamlines cleanroom project timelines.

  10. 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.