Featured Pharma Online Editorial

1. How To Avoid The Biggest USP <665> Compliance Trap 6/30/2026

   U.S. Pharmacopeia General Chapter <665> went into effect May 1. One expert explains why complex bioprocessing equipment trains present a greater obstacle than you might think.

2. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 2: Objective Measurement Tools 6/30/2026

   Let's examine the objective measurement tools that directly address each of the gaps between Annex 1 expectations and what drug manufacturing facilities can currently demonstrate in practice.

3. Inside Chugai's Digital Infrastructure Strategy 6/29/2026

   When a facility is fully automated and designed for manufacturing flexibility, it needs a digital infrastructure that pulls the systems together, reports data accurately and efficiently, and recognizes areas for continuous improvement.

4. FDA Explains How To Respond To Form 483 Observations In New Draft Guidance 6/29/2026

   In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look.

5. What Biopharma Often Overlooks In A Scheduled Shutdown 6/26/2026

   Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

6. Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures 6/23/2026

   A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

7. Does The FDA's Plausible Mechanism Pathway Revolutionize The Way All Risks Are Analyzed? 6/23/2026

   The FDA's new guidance on plausible mechanisms represents the first regulatory guidance-driven example of where the primary information source of a risk analysis is shifted from data-based to mechanism-based evidence.

8. 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.

9. 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.

10. 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.