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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
Chamber temperature alone cannot demonstrate lethality for terminally sterilized liquid products. Learn how heat penetration, product F₀, counterpressure, and container-closure integrity drive the selection and validation of saturated-steam, AOP, steam–air mixture, and superheated-water autoclave cycles.
USP Pharmacopeial Forum 52(5) introduces proposals covering oral drug product leachables, glycol impurity testing in ethoxylated substances, and revisions to USP General Notices. Explore the key changes and their practical implications for pharmaceutical manufacturers and laboratories.
Swissmedic has issued new guidance defining requirements for the Responsible Person for Pharmacovigilance and deputy, including qualifications, duties and oversight.
EMA has revised its Shortage Prevention Plan guidance, introducing new risk assessment criteria, market-share thresholds, supply chain classifications, and a two-day submission requirement ahead of the mid-2027 legal deadline.
Ph. Eur. proposes a new capillary GC method and tighter limits for ethylene glycol and diethylene glycol in Macrogols (1444). The revision also updates identification testing and could require changes to specifications, analytical procedures, and supplier controls.
FDA Warning Letter analysis of Dabur India Limited covering CGMP violations, data integrity failures, import alert, recalls and remediation expectations.
