FDA has published final guidance documents regarding validation and development of analytical procedures. On March 7, 2024, FDA published two final guidance documents regarding analytical procedures ...

Regulatory expectations and requirements continue to evolve to ensure the quality and safety of drug products. Over the last five years, we have seen increased focus during regulatory inspections ...

QC laboratories perform a critical role in demonstrating pharmaceutical products are consistently manufactured, safe, potent, and pure. At the same time, the number of tests run by QC laboratories is ...

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based ...

Dublin, Nov. 18, 2022 (GLOBE NEWSWIRE) -- The "Lifecycle Management of Analytical Methods and Procedures : Current Trends & Your Questions Answered" training has been added to ResearchAndMarkets.com's ...