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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
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
Transport validation in GDP: how to qualify lanes and packaging, design studies, manage excursions, and maintain ongoing control with risk-based evidence.
Cleanrooms explained: what they control, ISO 14644 classes vs EU GMP Grades, where they’re used, and how monitoring, trending, and CAPA demonstrate control.
Practice-oriented guide to pharmaceutical complaint management: definitions, risk-based triage, investigations, CAPA, recall interfaces, and trending KPIs.
What moist heat sterilization really means in GMP: mechanisms, cycle types, limitations, and regulatory expectations beyond 121 °C for 15 minutes.
