Featured Pharma Online Editorial

  1. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

    Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

  2. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

  3. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

    The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

  4. The Building Blocks For Successful CDMO–Pharma Relationships For Packaging Operations 12/4/2024

    The building blocks of such successful packaging relationships include a thoughtful approach to quality service agreements, a culture of transparency, and more.

  5. 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.

  6. Should You Be Using Unique Container Identification? 8/22/2024

    Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

  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. 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.

  9. Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation 7/23/2024

    In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.

  10. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.