Featured Pharma Online Editorial

1. A Look At Pharmaceutical Inspection Machine Advanced Technologies 2/7/2025

   Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.

2. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

   This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

3. Can Our Current Operational Processes Survive In 2025 And Beyond? 12/19/2024

   As long as operating procedure improvements are confined to a single function or sub-area, the benefits will be limited to that context. What can we do for true process improvement across our organization?

4. CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides 11/18/2024

   Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

5. A Guide To QbD For Small Molecule Drug Product Manufacturing Excellence 11/13/2024

   Leveraging the quality by design (QbD) approach to achieve manufacturing excellence is game-changing. This article shares QbD principles, benefits, and successful case studies.

6. Expert Voices: Why Aren't QC Labs Fully Automated Yet? 10/4/2024

   Leading automation experts chime in on why QC labs, otherwise ideal for robotics, have been slow to adopt and standardize the technology.

7. 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.

8. 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?

9. A Year In, Sanofi's Journey With Plai AI Is Aiding Quality Decisions 8/30/2024

   Sanofi has been a vocal of advocate of AI/ML for years. Here's how it's using technology to facilitate the audit process and get to the bottom of deviations faster.

10. 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.