FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations
FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and steps for compliance.
EDQM Publishes Revised Ph. Eur. Water Monographs for Feedback
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.
FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations
FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation, and labeling issues.
FDA Issues Warning Letter Due to cGMP Violations
FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification.
EDQM Presents 10 Common Deficiencies in New CEP Applications for Chemical Purity
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.
FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products
Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products.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.
SwissMedicines Inspectorate: Interpretation of GMP Annex 1 [2022]
Swissmedicines Inspectorate interprets the 2022 GMP Annex 1 guidelines, offering crucial insights into pharmaceutical manufacturing quality. Stay informed with GMP Insiders.