Quality Featured Articles

  1. Scope 3 Emissions: A Shared Challenge, A Collective Responsibility 6/13/2025

    Despite growing sustainability efforts, our industry lags in climate goals, especially Scope 3 emissions. Discover why bold action and deep collaboration across the value chain are essential for real progress.

  2. How A Rigorous Approach Delivers Unparalleled Results 6/12/2025

    In critical environments where mistakes have serious consequences, a disciplined, methodical approach isn't just a preference—it's the only path to success and long-term operational excellence.

  3. What Drug Manufacturers Should Know About Operational Readiness 6/4/2025

    Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.

  4. The Hidden Threat To Product Purity: Neglected Seals In Synthesis Columns 6/3/2025

    In biopharmaceutical manufacturing, seemingly minor components like seals can pose significant risks to product purity. Overlooking them can lead to contamination and costly delays.

  5. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  6. Revolutionizing Pharma Validation With AI 5/28/2025

    Validation in GxP environments is often the bottleneck in digital transformation—manual, repetitive, and complex. One company's Intelligent Agents are transforming that process.

  7. What Is The Position Of Regulatory Authorities On PUPSIT? 5/2/2025

    PUPSIT and other integrity testing methods are crucial for manufacturers to reduce contamination risks and ensure drug product safety. Learn how your company can adhere to updated regulatory guidelines.

  8. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  9. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

    The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

  10. Addressing Challenges In Automated Visual Inspection Of Lyophilized Vials 3/4/2025

    Manual inspection is inefficient. Automated systems can struggle with the variability of lyo cake structures. Key technological advancements are coming to the forefront to address these issues.