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 Building 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. 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.

  4. 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.

  5. 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).

  6. 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.

  7. Implementing AI Solutions In GMP While Managing Risk 8/28/2026

    When using artificial intelligence in GMP settings, risk management extends far beyond  validation. This discussion explores moving AI solutions out of the pilot phase.

  8. AI Needs Human Oversight To Better GMP Documentation 8/12/2026

    In a Pharmaceutical Online Live discussion on building inspection-ready systems with digital documentation, panelists emphasized that AI can accelerate review, trend analysis, and inspection response, but only when governed, validated, and kept firmly under human quality oversight.

  9. Building AI Readiness Through Cross Collaboration 7/22/2026

    AbbVie’s Operations Quality Assurance Innovation Accelerator offers a practical model for moving from AI enthusiasm to governed, people-centered execution.

  10. Bayer Adds A Spine To Modularity For Scale Without Disruption 7/16/2026

    Modular facility concepts offer a different path, giving manufacturers the ability to expand capacity stepwise, standardize core infrastructure, and adapt production environments as product portfolios evolve