Contributing Editors

  1. New Guide Aims To Build Robust Framework For Digital Validation Tools 10/22/2025

    The ISPE's new guide addresses software for managing digital assets related to qualification, verification, validation, and compliance assurance.

  2. 100% U.S. Drug Tariffs: Implications For Pharma And Outsourcing 10/17/2025

    Research Manager Mathini Ilancheran explores the effects of U.S. drug tariffs on global supply chains, multinational pharma firms, and critical partners across drug development.

  3. September 2025 — CDMO Opportunities And Threats Report 10/14/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  4. Risk-Based Analytical Method Selection In Cleaning Validation Using ASTM International Standards 10/14/2025

    This in-depth article describes risk in cleaning and provides a science- and risk-based framework for selecting analytical methods using ASTM International standards.

  5. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

  6. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

  7. Derisking AI Means First Asking: Who Does It Serve? 9/26/2025

    Ethical and accountability questions still swirl around how we use artificial intelligence in drug development.

  8. Defining Strong Program Management In CDMO Partnerships 9/23/2025

    This first article of a planned three-part series discusses the pitfalls that program managers help sponsor companies avoid, how program managers accelerate timelines or reduce risk, and more.

  9. Sanofi's Digitalization Road Trip Shifts Into High Gear 9/16/2025

    The company's head of manufacturing discusses their latest investments in AI and automation, plus offers tips on how any company can start adopting advanced technology.

  10. Why Pharmaceutical And Medical Device Risks Must Be Analyzed By Their Risk Mechanisms 9/16/2025

    Current risk analysis methods focus on the possibility and severity of bad events instead of focusing directly on analyzing and improving the performance of systems and processes producing the bad events.