The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on the new chapter 5.28 on Multivariate Statistical Process Control. The Ph. Eur. is the first pharmacopoeia to elaborate such a chapter.
Multivariate statistical process control (MSPC) can be defined as the application of multivariate statistical techniques to increase the quality and the productivity of a process. It provides tools to deal with complex data and potentially correlated variables. MSPC in combination with automation may facilitate continuous manufacturing (CM) as well as real-time release testing (RTRT). It can be integrated with other approaches such as Process analytical technology (PAT), Quality by Design (QbD), and Design of Experiment (DoE) in line with relevant ICH guidelines.
This general chapter is an introduction to the use of MSPC for monitoring and controlling manufacturing processes. It is intended to be for information only and will not become legally binding. The aim is to provide data analytical tools, complementing chapter 5.21 “Chemometric methods applied to analytical data” that help to analyse data from analytical methods as well as manufacturing processes. The objective is to provide guidance on good practices and requirements.
The chapter contains the following sections:
- General introduction
- Introduction to Statistical Process Control (SPC)
- Introduction to Multivariate Statistical Process Control (MSPC)
- Theoretical background
The chapter has been published for public consultation in Pharmeuropa 31.3 (July issue) and the commenting period ends on 30 September 2019. All interested users are strongly encouraged to review the draft and submit their comments.