Contributing Editors

  1. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.

  2. 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.

  3. 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.

  4. 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.

  5. 8 Actions To Redefine Sponsor–CDMO Relationships 4/22/2025

    When viewing a CDMO as merely a service provider, interactions are often limited to completing tasks. This mindset can stifle innovation and problem-solving.

  6. We Must Rethink The Solvents We Use For Peptide Synthesis 4/21/2025

    While the effectiveness of GLP-1 in weight loss is good news, the use of organic solvents in the GLP-1 synthesis and purification process is a growing pain that needs to be addressed.

  7. 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. 

  8. Why Pharma Risk Assessments Should Include 'Working Together Alone' 4/16/2025

    When understood and managed properly, subjectivity becomes a source of creativity. It reveals hidden hazards and unlocks more effective risk controls.

  9. Recent Developments Identifying Interactive Factors Affecting Tablet Scuffing Seen In The Aqueous Film Coating Process 4/16/2025

    There are three primary root causes of tablet scuffing during the aqueous film coating process, and titanium dioxide plays a role. The author provides recommendations for addressing it.

  10. 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.