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 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.
Articles Manufacturing QA QC Cleaning Validation In the Pharmaceutical Industry 28 January 2024 gmpinsiders Explore the essentials of cleaning validation in the pharmaceutical industry, including all necessary steps, challenges, and regulatory standards.
Articles GDP Maintenance Manufacturing Microbiology QA QC Regulatory Good Documentation Practice: Ensuring Data Integrity and Compliance in the Pharmaceutical Industry 14 December 2023 gmpinsiders Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.
News FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products 3 December 2023 gmpinsiders Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products.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.
Articles QA Regulatory GMP Regulatory Bodies: Understanding the Key Differences 1 December 2023 gmpinsiders Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide.