When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect. Analytical method transfer suffers from many of the same ...

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with ...

Techniques like SPME and QueChERS enhance sustainability by minimizing solvent and consumable use in sample preparation. With ...

Pharmaceutical Separation Science Session Day two of HPLC 2025 concluded with a session on pharmaceutical separations chaired ...

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 ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...

Stay ahead of the curve with our 2nd edition Analytical Method Validation & Lifecycle Management Masterclass - US Edition. Learn about the latest ICH guidelines, including the new ICH Q14 for ...