Quality by Design (QbD) is a science and risk based approach for pharmaceutical process development and manufacturing that begins with first defining clinically relevant product attributes and then designing and implementing a process to consistently deliver quality product. Some key aspects of QbD implementation are: (a) execution of a comprehensive risk assessment to identify material and/or process parameters that affect finished product quality, (b) understanding of multivariate interactions of process parameters and material attributes, and (c) implementation of a robust control strategy to ensure consistent quality. Knowledge management is pivotal for successful implementation of QbD to ensure that process understanding is routinely monitored and updated throughout the product life cycle.
Since the launch of the Office of New Drug Quality Assessment (ONDQA) CMC pilot program in July 2005, many QbD containing applications have been submitted, reviewed, and approved, both within and outside of the pilot. The objective of this presentation is to provide insight about the current state of QbD implementation as garnered from the QbD applications submitted to date. In addition, some remaining scientific and regulatory challenges will be discussed.&'
Would you like to access this content?
No problem. You just have to complete the following steps.
You have completed 0 of 2 steps.
You must be logged in to view this content. Log in now.
Purchase Technical Presentation
You must purchase this technical presentation using one of the options below.
If you already purchased this content recently, please click here to refresh the system's record of ownerships.
|Credits||0.5 Use credits|
|List Price||$25.00 Buy now|
|AIChE Members||$15.00 Buy now|
|AIChE Undergraduate Student Members||Free Free access|
|AIChE Graduate Student Members||$15.00 Buy now|