News Draft EDQM General Chapter 5.38: Quality of Data 21 October 2024 gmpinsiders EDQM releases draft chapter 5.38 on data quality in pharma, emphasizing standards, governance, and SME involvement.
News FDA Warning Letter Analysis: Diamond Chemical Co., Inc. 1 October 2024 gmpinsiders FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release, process validation, and stability testing. Explore the corrective actions and…
News Bionpharma Inc. Recalls Batch of Atovaquone Oral Suspension Due to Contamination 23 September 2024 gmpinsiders Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria.
News FDA Releases Updated Guidance on Controlling Nitrosamine Impurities in Human Drugs 5 September 2024 gmpinsiders FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety and compliance.
News FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations 13 August 2024 gmpinsiders FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and steps for compliance.
News EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback 25 July 2024 gmpinsiders EDQM releases updated Ph. Eur. water monographs, including key changes to Water for Injection, Purified Water, and TOC standards. Open for feedback until Sept 30, 2024.
News FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations 19 July 2024 gmpinsiders FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation, and labeling issues.
News FDA Issues Warning Letter Due to cGMP Violations 2 July 2024 gmpinsiders FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification.
News EDQM Presents 10 Common Deficiencies in New CEP Applications for Chemical Purity 21 March 2024 gmpinsiders EDQM comes with a comprehensive summary of the top 10 deficiencies that were observed during the evaluation of CEP applications for chemical purity in 2023.
News FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products 3 December 2023 gmpinsiders Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for eye care innovations.