Contributing Editors

  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. May 2025 — CDMO Opportunities And Threats Report 6/4/2025

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  4. The Matryoshka Model: The New Face Of Contract Packaging In Pharma 6/4/2025

    Contract packaging organizations are the outer layer of the pharmaceutical Matryoshka (the iconic Russian nesting doll): the final form that contains within it a series of intricately crafted parts.

  5. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

    As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

  6. 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).

  7. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  8. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

    The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

  9. Lilly's Calculated Approach To Upgrade Trade-Offs 5/22/2025

    If the disruption of implementing and adapting to new technology costs more than its benefits, teams should proceed cautiously.

  10. What Patients Say Matters: How AI Analyzes Sentiment to Improve Generic Drug Oversight 5/22/2025

    Employing multiple AI models to analyze public sentiment of generic drugs minimizes bias and enhances reliability. This makes AI a proactive tool for pharmaceutical quality assurance.