Featured Pharma Online Editorial

  1. ICH M4Q(R2) And M16 Modernize The CTD For Digital Submissions 9/28/2026

    A former FDA assessor explains how recent changes to the common technical document bring long-overdue updates to the submission process, accounting for greater data demands.

  2. 4 Ways To Build A Better CMC Tech Transfer 9/23/2026

    A technology transfer can falter long before a process reaches the plant. Gaps in process knowledge, mismatched equipment, and insufficient scale-up data can all undermine reproducibility, timelines, and cost.

  3. US Pharma Reshoring: The Full Policy Timeline 9/17/2026

    As policy shifts and manufacturing investments reshape pharma supply chains, capacity constraints and global dependencies persist. Explore the implications for long-term resilience.

  4. The Reliance Trap: When Regulatory Strategy Becomes A Clinical Supply Problem 9/17/2026

    The wrong regulatory filing sequence can close faster pathways, delay importation, and consume shelf life. Here’s how regulatory strategy can reshape clinical supply.

  5. What FDA Inspectors Want From Your OOS File 9/16/2026

    Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.

  6. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.

  7. Building Trust In AI For Computerized System Validation 9/4/2026

    Using AI for CSV might feel like the students are grading their own papers. One consultant explains why it's not the same, namely, there are no subjective judgment calls.

  8. When To Trust And When To Verify AI-Enabled Validation Systems 9/3/2026

    Computer software assurance, coupled with AI, can help validation teams reduce redundant work and spend more time on patient-centric issues.

  9. CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture 9/2/2026

    Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.

  10. AI Governance Is Just Like Driving A Race Car 9/1/2026

    Though some skeptics remain, nearly every business is at some stage of AI adoption. The technology has proven applications in pharmaceutical manufacturing, but effective governance must keep pace with its rapid development. That challenge is familiar to Bill Reid, healthcare and life sciences lead in Google’s Chief Information Security Office (CISO).