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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
A practical guide to ISO 7 cleanrooms in pharmaceutical manufacturing, covering classification, HVAC, monitoring, material flow, gowning, and cleaning.
Pharmeuropa 38.2 introduces draft revisions to bacterial endotoxin testing, particle-size analysis, and sieve chapters, with comments open until 30 June 2026.
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FDA’s draft guidance on Form 483 responses outlines what drug manufacturers should do on timing, investigation, risk assessment, and effective CAPA.
