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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
Pharmeuropa 38.3 introduces proposed European Pharmacopoeia revisions affecting microbiological quality, pesticide residues, and delivered dose testing. This article explains the key draft changes, their potential GMP impact, and what pharmaceutical companies should review before adoption.
FDA's revised Compliance Program 7346.832 changes how Preapproval Inspections (PAIs) are planned, scoped, and conducted using a more risk-based inspection model.
The 2026 revision of EU GMP Annex 19 introduces focused updates for reference and retention samples, mainly affecting parallel trade, re-packaging operations, packaging material retention, and the controlled use of photographic or digital retention samples.
Learn how Quality Risk Management under ICH Q9(R1) supports risk-based GMP decisions, inspection readiness, risk control, and pharmaceutical quality.
Learn the main types of pass boxes used in GMP facilities, including static, dynamic, and specialized units for controlled material transfer.
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.
