Featured Pharma Online Editorial

31. The 3 Phases of QRM – An Inspector's View 5/14/2025

    Quality resource management has three phases: assessment, control, and review. The experts at GMP Compliance Advisor bring us this breakdown of all of them.

32. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

    Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

33. From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025 5/7/2025

    The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.

34. Addressing Human "Error" In Pharma Manufacturing 5/7/2025

    Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.

35. A Facilities Expert Answers Audience Questions On Construction And Validation 5/5/2025

    Bioprocessing facility expert Herman Bozenhardt responds to some unanswered audience questions from a Pharmaceutical Online Live event on facility design and validation.

36. Experts' Advice On Facility Design And Construction 4/24/2025

    This is a review of the Pharmaceutical Online Live event “Facility Design And Validation Considerations For Drug Manufacturers," which featured industry experts Erich Bozenhardt and Herman Bozenhardt, as well as process architect Fred Grossfeld.

37. FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating 4/24/2025

    Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for defensive and offensive strategies.

38. 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.

39. 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.

40. Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers 4/17/2025

    The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.