Guest Columns

1. An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs? 10/28/2026

   FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

2. Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty 10/22/2026

   Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.

3. Is Your Supply Chain Ready For The End Of Class VI? 10/21/2026

   Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.

4. When Lyophilization Fails At Scale, First Scrutinize Your Formulation 10/16/2026

   When lyophilizing a challenging biologic drug product, use an integrated approach optimizing formulation and process parameters together.

5. The 5 Shifts That Could Remake Lyophilization By 2040 10/15/2026

   Purdue University-based LyoHUB charts a risk-based course to modernizing freeze-drying technology for better performance and advanced modalities.

6. Your 7 Decisions To Make Before MES Configuration 10/7/2026

   Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

7. Qualification And Validation Of Depyrogenation Tunnels And Autoclaves 10/2/2026

   Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

8. DEA Reveals Hidden Costs Of Analytical Validation Guidelines 10/2/2026

   By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

9. FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters 10/1/2026

   The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

10. You Can't CAPA What You Can't Classify 9/16/2026

    An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.