ICH Q12 Should Build on the ICH Q8 Design Space

by Mark F. Witcher, PhD
Volume 17, Open Access (September 2018)

The current draft of ICH Q12 appears to have taken several steps backward in the pursuit of the manufacturing excellence initiated by ICH Q8 (R2) pharmaceutical development and expanded by FDA’s 2011 process validation guidelines...

Witcher MF. ICH Q12 should build on the ICH Q8 design space. BioProcess J, 2018; 17. https://doi.org/10.12665/J17OA.Witcher.0905.

Posted online September 5, 2018.