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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
Software validation vs verification explained under EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5, with practical examples and inspection-ready guidance.
Terminal sterilization vs aseptic processing explained. Compare sterility assurance levels, risks, validation expectations, and GMP regulatory guidance.
FDA Warning Letter to Rhyz Analytical Labs cites CGMP failures in OOS investigations and Quality Unit oversight at a contract testing laboratory.
Understand GAMP 5 with simple guidance on lifecycle control, validation deliverables, software categories, and risk-based decision-making in GMP environments.
Primary vs secondary reference standards explained: definitions, qualification, traceability, uncertainty, and regulatory expectations in GMP labs.
Overview of ISO 5 cleanroom standards, airflow control, monitoring requirements, and qualification steps under ISO 14644-1
