Europe – European Pharmacopoeia: Adoption of a new general chapter on Multivariate Statistical Process Control

At its 166th session (March 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new chapter on Multivariate Statistical Process Control (5.28)The Ph. Eur. is the first pharmacopoeia to tackle this topic.

The Commission also adopted a revised version of chapter 5.25 on Process analytical technology, which has been updated to refer to the newly elaborated chapter 5.28.

Multivariate Statistical Process Control (MSPC) can be defined as the application of multivariate statistical techniques in order to analyse complex process data with potentially correlated variables. MSPC in combination with automated data collection and analysis may be used to generate control charts based on a multivariate (chemometric) model. These charts can then be used to control and improve manufacturing processes. In combination with a high degree of automation, MSPC may facilitate continuous manufacturing (CM), as well as real-time release testing (RTRT). It can be combined with process analytical technology (PAT), quality by design (QbD) and design of experiments (DoE), in line with relevant ICH guidelines.

This general chapter provides an introduction to the use of MSPC. The objective is to give guidance on good practices: it is intended to be for information only and will not become legally binding. It gives an insight into the principles of MSPC and the development and use of multivariate control charts, and provides an overview of the theoretical background of multivariate statistical procedures…