Featured Pharma Online Editorial

  1. The Orange Book's Blind Spot: Process Stability And Capability 10/5/2026

    The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.

  2. Why CMC Tech Transfer Should Begin With The End In Mind 10/1/2026

    This interview with Sai Life Sciences’ Tuneer Ghosh explains why CMC technology transfer should begin with commercialization and lifecycle goals in mind. It highlights how early planning for scale, CDMO involvement, supply resilience, regulatory requirements, process safety, and shared learning can support a smoother, more sustainable transfer.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

  9. Controls For Retrieval-Augmented Generation In GxP 9/1/2026

    Validation teams deal with inherent variability all the time. The same principles for GMP — think visual inspection — can apply to probabilistic AI systems.

  10. FDA Issues New Guidance On Therapeutic Equivalence 9/1/2026

    The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?