What are the critical attributes necessary for quality by design (QbD) in sterile manufacturing and aseptic processing? What are the challenges and advantages? The answers to these and other questions are answered in the BioPharm International article from Wolfgang Weikmann, Vice-President Quality Assurance.
Properly employed, quality by design can significantly improve the manufacturing process in sterile manufacturing. But a high degree of expertise must be in place in order to run a proper sterile QbD operation. Risks, for example, must be identified in an early stage and a strategy to deal with them implemented from the very beginning of the commercial stage. And while time, cost and resources in the early development stage can be formidable if not addressed early and properly, processes such as tech transfer are especially improved through a QbD approach. Learn more about the advantages of management of QbD and how it is best used in the following article.
Implementing QbD in Sterile Manufacturing