Featured Pharma Online Editorial

  1. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals 9/11/2024

    The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

  2. Pharmaceutical Continuous Manufacturing: Content Uniformity With PAT And RTR 9/4/2024

    Content uniformity is one of the most important release criteria for solid dosage forms. In continuous manufacturing, what process analytical technologies (PAT) are available to measure and assure content uniformity as part of a real time release (RTR) strategy?

  3. EMA Issues New Draft Guideline: Chemistry Of Active Substances 9/3/2024

    The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

  4. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

  5. 2024 Emerging Trends In Cleanroom Technologies 8/14/2024

    This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.

  6. VR/XR In Drug Manufacturing: No Longer Sci-Fi 8/13/2024

    Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.

  7. Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection 8/7/2024

    This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.

  8. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

  9. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

    The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

  10. Is Your Lab Ready For A LIMS Implementation? 7/25/2024

    Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.