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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’s final Q3 guidance for topical ANDAs clarifies how physicochemical and structural characterization supports dosage form assessment and bioequivalence.
USP–NF PF 52(2) proposes updates to sterilization chapters, sterile filtration, particulate testing, analytical sieving, and melting point standards.
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FDA’s draft guidance on Form 483 responses outlines what drug manufacturers should do on timing, investigation, risk assessment, and effective CAPA.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.
