Featured Pharma Online Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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. 

  9. Climbing The Blockchain Ladder To Optimize Clinical Supply Forecasting 4/16/2025

    Layering AI on top of blockchain technology offers a powerful way to predict kinks in the supply chain. Here's a look at where the technology is headed.

  10. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

    In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.