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FDA’s 2025 CSA guidance introduces a risk-based approach to software assurance, reducing burden and aligning with ISO 13485:2016 compliance....
FDA issues Warning Letter to Somerset Therapeutics citing major cGMP failures in aseptic practices, investigations, and reporting....
Draft revisions to GMP Chapter 1 focus on risk-based oversight, early warning systems, supply chain risks, and improved Product Quality...
USP–NF PF 51(5) draft introduces updates in microbiology, transport, particulates, and dosage form guidance, emphasizing risk-based GMP compliance....
PDG updates Q09 on sub-visible particulate contamination after 20 years, harmonising standards for safer parenteral medicines....
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...
The 2025 EU GMP draft revisions to Chapter 4, Annex 11, and Annex 22 bring major changes to documentation, computerized...
USP–NF PF 51(4) introduces draft chapters on data integrity, suspensions, disinfectants, chemometrics, and analytical lifecycle, impacting GMP pharma operations....
MDCG 2019-11 Rev.1 updates software qualification and classification under MDR/IVDR with new rules, modular guidance, and conformity insights....

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