Featured Pharma Online Editorial

31. Upskilling Your Quality Team For The AI Revolution In Pharma 4.0 3/21/2025

    While AI systems offer advanced capabilities for data analysis, process optimization, and quality assessments, your quality team must first be proficient in interacting with them.

32. What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025

    The draft aims to modernize the regulations in 21 CFR 211.110 catching up to progress in the field including advanced manufacturing and analytical technologies.

33. Areas For Advancement In Peptide Manufacturing 2/27/2025

    Experts from Eli Lilly, NervGen, and Piramal Pharma Solutions discuss the myriad of ways peptide manufacturing can be improved, drawing on years of industry experience and insight.

34. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

    AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.

35. 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.

36. 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?

37. 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?

38. 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.

39. 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.

40. 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.