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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–NF PF 51(5) draft introduces updates in microbiology, transport, particulates, and dosage form guidance, emphasizing risk-based GMP compliance.
Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices.
PDG updates Q09 on sub-visible particulate contamination after 20 years, harmonising standards for safer parenteral medicines.
ISO 14644-1 cleanroom classification explained: particle limits, GMP grade mapping, and key compliance insights for sterile pharma manufacturing.
ICH Q3E draft outlines global guidance for Extractables & Leachables, covering scope, risk assessment, AET, and regulatory expectations.
Annex 22 - EU's new draft regulatory framework for AI in GMP, focusing on model validation, performance, and risk management for quality and safety.
