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News FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products 3 December 2023 gmpinsiders Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products.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.
News SwissMedicines Inspectorate: Interpretation of GMP Annex 1 [2022] 8 November 2023 gmpinsiders Swissmedicines Inspectorate interprets the 2022 GMP Annex 1 guidelines, offering crucial insights into pharmaceutical manufacturing quality. Stay informed with GMP Insiders.
