Featured Pharma Online Editorial

  1. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

    Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

  2. What 2025 FDA Warning Letters Tell Us About GMP Compliance 12/15/2025

    This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

  3. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

    MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

  4. It's Copy/Paste In Fleet Management Manufacturing 12/11/2025

    Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.”  In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying the copy/paste action to standardized, decentralized facilities.

  5. FDA Issues Final Guidance For pH Adjuster Waiver Requests For Generic Drugs 12/11/2025

    The FDA has issued a final guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use.

  6. Lessons In Quality From Sanofi's Plai.qa 11/24/2025

    The platform orchestrates data to evaluate site maturity and performance and provide recommendations for improvement.

  7. Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk 11/21/2025

    Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.

  8. Here's What You Need To Know About The Access Consortium Pathway 11/20/2025

    Five nations are collaborating on a work-sharing program to reduce regulatory duplication in drug development.

  9. Is Charisma An API? 11/19/2025

    After nearly 20 years in the pharmaceutical industry, Samir Shah, director of regulatory CMC for medical products and combination products at AstraZeneca, knows how beneficial charisma can be for the pharmaceutical professional. That’s why he presented the topic at the 2025 RAPS Convergence.

  10. Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations 11/18/2025

    A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”