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Category: Regulatory Updates

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FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and...
Draft ICH E6(R3) Annex 2 provides updated GCP guidelines for modern clinical trials, focusing on decentralized designs, data privacy, and...
USP releases early adoption guidelines for non-animal endotoxin testing, promoting sustainable recombinant Factor C methods with strict validation standards....
EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement....
FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety...
EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open...
EDQM comes with a comprehensive summary of the top 10 deficiencies that were observed during the evaluation of CEP applications...
Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for...
Swissmedicines Inspectorate interprets the 2022 GMP Annex 1 guidelines, offering crucial insights into pharmaceutical manufacturing quality. Stay informed with GMP...