Application Note: Applying QbD in Process and Impurity Control Strategy Development
Posted: 29 March 2018 | ACD/Labs | No comments yet
Global regulatory authorities continue to push Quality-by-Design (QbD) on pharmaceutical groups and their supporting corporate informatics infrastructure…
Effective leveraging of QbD in risk mitigation requires informatics platform innovation; particularly to support reduction of data abstraction, data assembly, and human data preparation.
Informatics software for Impurity control should optimally provide users with the ability to construct ‘process maps’. The platform should also allow the user to visualise the wide variety of related spectroscopic and chromatographic data in a single environment for each stage and substance for efficient and informed decision-making.
Here we provide an overview of a new software application (LuminataTM)1 developed specifically to address these platform innovation needs.
The rest of this application note is restricted - login or subscribe free to access
Thank you for visiting our website. To access this content in full you'll need to login. It's completely free to subscribe, and in less than a minute you can continue reading. If you've already subscribed, great - just login.
Why subscribe? Join our growing community of thousands of industry professionals and gain access to:
- bi-monthly issues in print and/or digital format
- case studies, whitepapers, webinars and industry-leading content
- breaking news and features
- our extensive online archive of thousands of articles and years of past issues
- ...And it's all free!
Click here to Subscribe today Login here
Related content from this organisation
Related topics
Analytical techniques, Big Data, Lab Equipment, Research & Development (R&D), Technology
