As the industry is moving towards applying Quality by Design (QbD) to process development we find ourselves asking the following questions:
•Is this also the way forward to revolutionise, improve and standardise our approach to method qualification?
•Is ICH Q2 adequate to meet our current lifecycle needs?
•Should Technology Transfer be considered as part of the lifecycle approach rather than as a separate exercise?
•Can Technology Transfer be managed through the quality Change Control process?
These questions and more will be discussed.
•Is this also the way forward to revolutionise, improve and standardise our approach to method qualification?
•Is ICH Q2 adequate to meet our current lifecycle needs?
•Should Technology Transfer be considered as part of the lifecycle approach rather than as a separate exercise?
•Can Technology Transfer be managed through the quality Change Control process?
These questions and more will be discussed.
