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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
USP’s PF 52(3) drafts propose important updates to glass container chapters 〈660〉 and 〈1660〉, including new glass families, modernized identification methods, revised durability expectations, and updated GMP implications for pharmaceutical packaging qualification.
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.
