Validation, Commissioning & Design Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Biotech's Plastic Problem Meets Its Match 8/8/2025

    Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.

  7. What Happens When You Refuse To Compromise On Sustainability? 8/8/2025

    Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.

  8. Redefining Process Design And The Evolution Of Critical Process Parameters 8/6/2025

    Effectively managing process parameters and quality attributes is vital for successful drug development. Learn how a Quality by Design approach can optimize your processes and ensure product quality.

  9. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  10. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.