Contributing Editors

  1. EMA's New Guideline For Synthetic Peptides: A More Explicit CMC Playbook For A Growing Therapeutic Class 6/23/2026

    The European Medicines Agency’s Guideline on the Development and Manufacture of Synthetic Peptides, adopted in Dec. 2025 and effective from June 1, 2026, is an important regulatory development for peptide manufacturers.

  2. Hormuz Deal Brings Cautious Relief To Pharma Packaging Supply Chains 6/19/2026

    Restrictions and fear on the Hormuz Strait have fractured supply chains, especially for primary materials used in pharmaceutical packaging.

  3. Is Your AI Model Trustworthy And Credible In GMP Processes? 6/17/2026

    Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

  4. May 2026 — CDMO Opportunities And Threats Report 6/16/2026

    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.

  5. Setting The Tone For A Fill/Finish Engagement Program 6/15/2026

    The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success.

  6. Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation 6/8/2026

    Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

  7. A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis 6/5/2026

    This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

  8. Managing Organic Impurities And Nitrosamines In APIs 6/4/2026

    How API manufacturers can assess and mitigate organic impurities and nitrosamines using risk-based strategies aligned with global regulatory expectations.

  9. The Future Of Continuous Is Integrated Manufacturing: The 4 Misconceptions About A Lean Process 6/2/2026

    Pharmaceutical continuous manufacturing is an enabler of better manufacturing, but only when implemented with intention.

  10. CDMO Selection: Start With The Relationship, Not The RFP 6/1/2026

    Friction often comes from unspoken expectations. Before production begins, treat the combined sponsor-CDMO group as one extended team and intentionally make “how we work together” visible.