Featured Pharma Online Editorial

  1. Why Isolators Do Not Automatically Ensure Annex 1 Compliance 5/12/2026

    Isolators are powerful tools, but they do not automatically ensure compliance with EU GMP Annex 1. RABS are frequently dismissed too quickly. The difference is not the technology itself, but how it is applied.

  2. Why Are Life Science Companies So Poorly Prepared For RIM's Future? 5/11/2026

    Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

  3. [Video] Get It Right with The Gemba 5/8/2026

    The idea of the Gemba walk originated after World War II in Japan, specifically in relation to automotive production at Toyota. The word can be translated to “the real or actual place,” referring to where the work takes place—in the case of pharma or automobiles, on the factory floor.

  4. Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24 5/5/2026

    FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

  5. Causal Mechanism And Effect Analysis (CMEA): FMEA's Simpler, Effective Alternative 5/1/2026

    This article describes causal mechanism and effect analysis (CMEA) as an alternative to failure mode and effect analysis (FMEA) for analyzing and managing the industry’s risks.

  6. Making Mental Health Drugs: Promising Therapies And Manufacturing Challenges 4/30/2026

    Psychedelic therapies have shown promise in treating mental health disorders, but it will take close collaboration and cooperation of all related agencies and manufacturers to make this promise a reality.

  7. The Stepwise Path Lilly Mapped From Paper To Digital Logbooks 4/30/2026

    Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

  8. Building Quality Into Radiopharmaceuticals: A Look At EMA's Recent Guideline 4/28/2026

    The EMA's December 2025 draft guideline on expectations for the quality documentation of radiopharmaceuticals replaces the earlier 2007 guideline and reflects significant developments.

  9. Selecting The Right eQMS To Maximize Quality Maturity 4/23/2026

    Let's take a closer look at the current electronic quality management system (eQMS) landscape in pharma/biotech and what a future-ready eQMS must enable to support continuous improvement.

  10. FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing 4/22/2026

    The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.