Read, Learn, Innovate: Quality Topics in Pharmaceutical Engineering®
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are recent technical articles about quality, including global commissioning, qualification, and validation; data for verification; and addressing N-nitrosodimethylamine (NDMA) impurities.
Lessons Learned in Global CQV
Global commissioning, qualification, and validation (CQV) project delivery has in recent years been required to push the boundaries on delivery methodologies and techniques to ensure sufficient production capacity is available to meet ever-expanding patient needs. This article focuses on lessons captured in the execution and resource management of large-scale global CQV projects in an environment of change and compressed project timelines.
Risk-Based Continued Test-Method Performance Verification System
Good data are a characteristic of good science. Quality data are arguably more important today than ever before and are considered by many to be a corporate asset because they are used to develop products and processes, control our manufacturing processes, and improve products and processes when needed. Quality data also reduce the risk of poor process performance and help prevent defective pharmaceuticals from reaching patients.
Quality Risk Management to Address Product Impurities
Recently, recalls of angiotensin receptor antagonists, particularly valsartan, and warning alerts about N-nitrosodimethylamine (NDMA) impurities in drug substances such as ranitidine and metformin have demonstrated the urgent need for manufacturers and regulators to control impurities throughout the product life cycle to ensure patient safety. In this article, all plausible pathways related to the formation of NDMA impurities in pharmaceutical products and a possible control strategy using quality risk management (QRM) as a tool are discussed.
