When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?
The past decades have seen a maturation of the contract manufacturing and development organization (CDMO) business and an increased level of collaboration between pharmaceutical companies and CDMOs. This article explores a number of drivers behind this trend.
The story is a common one. Your organization has just acquired a new asset and you are responsible for finding the custom development and manufacturing organization (CDMO) that is going to take you all the way to commercialization. The hard part is over, right? If only it were that simple. The process of selecting your partner is more than just drafting an agreement; it is a complex give and take that relies on clear expectations and communication.
This two-part article will address how sponsors can effectively ensure confidence in data integrity at their contract development and manufacturing organizations (CDMOs) and have confidence in the information upon which they base lot release decisions.