Quality Featured Articles

  1. [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.

  2. What Validation Really Means For Visual Inspection Programs 5/8/2026

    True validation requires documented proof that inspectors and methods consistently catch defects. Move beyond static SOPs to a state of continuous, data-backed compliance and audit readiness.

  3. Enhancing Safety In Drug Substance Synthesis: A Smart Approach To Chemical Design 5/6/2026

    Discover how safety‑by‑design principles in chemical synthesis help control exothermic reactions, reduce scale‑up risk, and enable safer, more reliable manufacturing of complex drug substances.

  4. How Rheology Ensures Effective Quality Control 5/1/2026

    Rheology connects formulation science to manufacturing reality. By tracking how drugs flow and respond to stress, teams can prevent batch variability and protect dosage performance.

  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. A 5-Step Foundation For Early CQV Involvement 4/28/2026

    All too often, a project’s issues show up in CQV, and it is there that blame is pointed. However, these issues start earlier and are entirely avoidable with proper planning.

  8. 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.

  9. Strategic Supply Chain Leadership: Driving Biopharma Growth 4/22/2026

    Amid a volatile pharma supply chain, strategic sourcing is now critical. Prioritizing your raw material supply ensures operational continuity, consistent performance, compliance, and on-time delivery.

  10. Digital Process Twin Cuts J&J Production Time And Costs 4/22/2026

    Virtual process modeling is helping to cut production time, reduce solvent use, and improve sustainability. Learn how digital twins enable faster scale‑up decisions and more efficient manufacturing.