Featured Pharma Online Editorial

1. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

2. Advanced Process Risk Assessment And Control Strategy Development In Solid Oral Dosage Forms 6/5/2025

   Using four solid oral dosage drugs representing distinct manufacturing strategies, this article showcases that risk-based thinking and robust control strategies mitigates process variability.

3. Radiopharmaceuticals: Navigating FDA Guidance And CMC Considerations 6/2/2025

   The unique nature of radiopharmaceuticals necessitates specialized regulatory considerations, particularly for chemistry, manufacturing, and controls (CMC).

4. Small Molecule Pharma Companies Are Employing These Advanced Technologies To Get Ahead 5/19/2025

   Small molecule drug companies are employing these concrete innovations, including several associated with Pharma 4.0, all boosting quality and efficiency.

5. 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.

6. 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.

7. 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.

8. Growth And Trends In Topical Drug Contract Manufacturing 2/14/2025

   Rising incidences of dermatological conditions, including acne, psoriasis, and skin cancer, are driving growth in topical drugs. Pharma companies are increasingly using contract manufacturers.

9. 2024 Trends In FDA Observations For Sterile Drug Manufacturers 1/30/2025

   This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?

10. 11 Key Contributing Factors For Maintaining Sterility Assurance 1/6/2025

    Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.