QbD Knowledge Management Concept Paper
Members of the PAT CoP discuss QbD strategies for data and knowledge management, suggest solutions, and demonstrate potential benefits for improved quality and economy.
Download the Paper and join the discussion about it in the PAT Community Discussions.
The PAT COP has nearly 1,400 members aiming to apply PAT within the QbD framework. PAT activities are related to obtaining process understanding and the development and implementation of real time monitoring and control strategies for manufacturing processes.
The PAT COP creates a global focal point of support and a discussion forum for Pharmaceutical
Professionals interested in PAT. This means the creation and delivery of training, technical materials and
information, as well as providing opportunities for collaboration and networking. The PAT COP addresses
issues related to process understanding in development and manufacturing, process monitoring and control,
in-process analyzer technology, multivariate data analysis (DOEs, chemometrics), and fundamental knowledge of
the links between PAT and QbD, including the use of quality risk management.
As a PAT COP member you can access technical discussions or download presentations or files. You can complete a volunteer profile and share your expertise with the community. Note that only ISPE Members can engage in these activities.