A Novel Framework to Aid the Development of Design Space across Multi-Unit Operation Pharmaceutical Processes-A Case Study of Panax Notoginseng Saponins Immediate Release Tablet.

ABSTRACT: The fundamental principle of Quality by Design (QbD) is that the product quality should be designed into the process through an upstream approach, rather than be tested in the downstream. The keystone of QbD is process modeling, and thus, to develop a process control strategy based on the development of design space. Multivariate statistical analysis is a very useful tool to support the implementation of QbD in pharmaceutical process development and manufacturing. Nowadays, pharmaceutical process modeling is mainly focused on one-unit operations and system modeling for the development of design space across multi-unit operations is still limited. In this study, a general procedure that gives a holistic view for understanding and controlling the process settings for the entire manufacturing

SUBMITTER: Sun F 

PROVIDER: S-EPMC6781312 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature