Featured Pharma Online Editorial

  1. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

    This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

  2. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

    In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

  3. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

    This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.

  4. Rethinking CQV In A Digital, Agile Manufacturing Landscape 5/21/2026

    While commissioning, qualification, and validation (CQV) remains foundational, the way it is planned and executed must evolve to keep pace with modern manufacturing realities.

  5. [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.

  6. 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.

  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. 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. The Hidden Operational Cost Contained In Every Small Molecule Portfolio 4/21/2026

    The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.