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GMP Insiders Expert Team
The GMP Insiders Expert Team is a group of seasoned professionals specializing in quality assurance, regulatory compliance, and operational innovation in pharmaceutical and biotech manufacturing. United by a passion for advancing Good Manufacturing Practices, they transform complex compliance challenges into clear, actionable strategies that drive operational excellence.
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Latest GMP Posts
FDA Warning Letter analysis of Novo Nordisk’s PADE violations, including missed 15-day Alert reports, weak ADE investigations, vendor oversight gaps, and inadequate CAPAs.
FDA’s draft guidance on Form 483 responses outlines what drug manufacturers should do on timing, investigation, risk assessment, and effective CAPA.
Learn how fluid bed technology is used in pharmaceutical manufacturing for drying, wet granulation, and coating, with a practical focus on fluidization, process parameters, PAT, scale-up, and troubleshooting.
A GMP-aligned, risk-based decision tree for moist heat sterilization in pharma, covering cycle selection, validation strategy, F₀ use, and routine batch release.
EU GMP Annex 6 revision (2026 concept paper): premises rationale, valves/couplings, flow-check frequency, hospital liquid oxygen documentation, and batch release.
EMA & PIC/S consult on revising EU GMP Annex 15 for active substances: scope, Q&V governance, investigations, CPV and GDP interface. Comment by 9 Apr 2026
