Pharmaceutical Technology, May 2023

Optimizing the Manufacture of Emerging Therapies

May 02, 2023

Quality/Regulations

47

5

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

Total Analytical Error in Validation of Analytical Procedures of Pharmaceuticals

May 02, 2023

Peer Reviewed

47

5

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors.