Featured Pharma Online Editorial

1. 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.

2. ADCs Unleashed: Navigating Development Hurdles In Targeted Cancer Therapy 5/12/2025

   Despite their potential to revolutionize treatment paradigms, antibody-drug conjugates (ADCs) face challenges that companies must tackle for successful development.

3. A Road Map For PAT Monitoring And Control 5/8/2025

   Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.

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. 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.

6. 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.

7. Amgen's Deep Learning Approach To Vial Inspection 3/31/2025

   The company is testing how artificial intelligence can help bring down the number of false rejections caused by factors like glare on the glass or bubbles in the vial.

8. 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.

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 What FDA Draft Guidance Tells Us About In-Process Control Strategies 2/28/2025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

10. 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.