The Infona portal uses cookies, i.e. strings of text saved by a browser on the user's device. The portal can access those files and use them to remember the user's data, such as their chosen settings (screen view, interface language, etc.), or their login data. By using the Infona portal the user accepts automatic saving and using this information for portal operation purposes. More information on the subject can be found in the Privacy Policy and Terms of Service. By closing this window the user confirms that they have read the information on cookie usage, and they accept the privacy policy and the way cookies are used by the portal. You can change the cookie settings in your browser.
This chapter contains sections titled:
Introduction
Approach Toward Process Characterization
Risk Analysis
Small‐Scale Model Development and Qualification
Design of Experiment Studies
Worst Case Studies
Definition of Design Space
Definition of Validation Acceptance Limits
Regulatory Filing, Process Monitoring, and Postapproval Changes
Acknowledgment
References
The concepts, applications, and practical issues of Quality by DesignQuality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products;...
This chapter contains sections titled:
Introduction
Critical Quality Attributes
An Overview of Design Space
Raw Materials and their Impact on QbD
Process Analytical Technology
The Utility of Design Space and QbD
Conclusions
References
Set the date range to filter the displayed results. You can set a starting date, ending date or both. You can enter the dates manually or choose them from the calendar.