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Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria....
FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety...
FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and...
EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open...
FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation,...
FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification....
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Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products.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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