Validation, Commissioning & Design Featured Articles

  1. Your Environmental Monitoring Can't Be Your Only Line Of Defense 9/1/2025

    Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

  2. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  3. Conquering Challenges In Viral Vector Production 8/27/2025

    Scaling gene therapy demands precision and actionable data. Discover how integrated technologies like ultracentrifugation and mass spectrometry enhance AAV yield, purity, and characterization.

  4. Pharma QMS: Simplify Your Quality Management Practices 8/27/2025

    Manufacturers are embracing advanced technologies to enhance Quality Management Systems and ensure faster defect detection and compliance with FDA standards. Learn more about key pharma QMS features.

  5. Overcoming Challenges In Ophthalmic Formulations Through Polymer Selection 8/27/2025

    The growing demand for ophthalmic drugs is driven by aging populations and increased screen time, which contributes to rising eye conditions. Explore innovative solutions in ophthalmic drug development.

  6. New FDA White Paper Ties Quality To Financial Benefits 8/26/2025

    The agency presents as a stepwise approach in which companies can make incremental investments rather than committing large amounts of capital upfront.

  7. The High Requirements Placed On Pharmaceutical Labeling Solutions 8/18/2025

    Regulators are implementing new rules to combat counterfeit medicines. Learn how serialization, tamper-evident seals, and track-and-trace solutions protect products and patients from risk.

  8. Choosing A PCD Configuration For Your Cycle 8/15/2025

    Ethylene Oxide (EO) sterilization is essential for medical device safety. Explore how Process Challenge Devices help validate and monitor EO processes with precision across a wide range of applications.

  9. Enhancing Ethylene Oxide Sterilization Processes 8/15/2025

    PCDs are patented devices designed to meet the demands of EO sterilization. Gain insight into how they support process development, validation, and monitoring with reliable, reproducible performance.

  10. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.