Articles Manufacturing Powders, Granules, and Tablets: What is the Difference 23 October 2024 gmpinsiders
Articles Manufacturing Powders, Granules, and Tablets: What is the Difference 23 October 2024 gmpinsiders
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.
Articles QC RP vs NP Chromatography: Key Differences Explained 2 September 2024 gmpinsiders Discover the key differences between RP-HPLC and NP-HPLC. Learn how these contrasting chromatography techniques drive effective compound separation and analysis for diverse applications.
Articles QA Validation Master Plan (VMP) In the Pharmaceutical Industry 24 August 2024 gmpinsiders Learn how to create a comprehensive Validation Master Plan (VMP) to ensure consistent product quality and regulatory compliance
Articles QC Expiry Dates for Commercial and In-House Prepared Reagents In QC Labs 20 August 2024 gmpinsiders Discover the best practices for establishing and managing expiry dates for commercial and in-house prepared reagents in QC labs.
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.
Articles QA Different Types of GMP Documentation Used In Pharma Industry 5 August 2024 gmpinsiders Explore the different types of GMP documentation in the pharmaceutical industry, essential for maintaining quality, compliance, and safety in manufacturing processes.
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.
Articles Manufacturing Primary vs Secondary Packaging in Pharma Industry 22 July 2024 gmpinsiders Explore the critical role of primary vs secondary packaging in the pharmaceutical industry, highlighting differences, protection, preservation, and regulatory 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.
Articles Maintenance Manufacturing QA QC IQ, OQ and PQ: Importance in GMP 16 July 2024 gmpinsiders Discover the importance of IQ, OQ, and PQ in GMP, ensuring equipment and systems are installed and function correctly to maintain high-quality manufacturing standards.