Featured Pharma Online Editorial

41. What Biopharma Often Overlooks In A Scheduled Shutdown 6/26/2026

    Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

42. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures 6/23/2026

    A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

43. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

    The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

44. EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class 6/23/2026

    The European Medicines Agency’s Guideline on the Development and Manufacture of Synthetic Peptides, adopted in Dec. 2025 and effective from June 1, 2026, is an important regulatory development for peptide manufacturers.

45. Is Your AI Model Trustworthy And Credible In GMP Processes? 6/17/2026

    Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

46. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

47. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

    This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

48. Why FAT Should Confirm Alignment, Not Reveal Its Absence 6/1/2026

    In many aseptic fill/finish projects, the factory acceptance test (FAT) has become the first true integration test of the entire project. That is a problem. Here's how to flip that mindset.

49. What Reliance, Annex 1, And AI Mean For The Future Of GMP 5/29/2026

    EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

50. Applying Contamination Control By Design: A Practical Guide For CDMOs 5/26/2026

    This article addresses the three contamination control challenges that are specific to the CDMO environment, provides five practical steps any organization can act on now, and more.