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Category: Regulatory Updates

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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Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products.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...

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