After January 2013 the Office of Generic Drugs (OGD) expects abbreviated new drug applications (ANDAs) to implement QbD (Quality-by-Design). To help generics manufacturers make the transition the US Food and Drug Administration (FDA) is publishing examples of QbD development.
“The purpose of the example is to illustrate the types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their development process and to promote discussion on how OGD would use this information in review”, the FDA wrote in its 161-page document.
In the example the FDA uses a QbD approach to develop a tablet formulation and manufacturing process for a fictitious modified release generic product. The document charts the process from analysis of the innovator product through to lifecycle management and continual improvement.
Speaking in at AAPS in November, Lawrence Yu, deputy director, science and chemistry, FDA, told in-PharmaTechnologist: “We plan to use the examples to train our staff within OGD and also hopefully help the industry understand what QbD is about and what they need to do fully adopt QbD.”
As well as the modified release example, the FDA is working on a document for immediate release dosage forms. Yu said both documents have been written in collaboration with the generics industry.
QbD steps
The FDA example emphasises the use of risk assessment in QbD development. “Risk assessment was used throughout development to identify potentially high risk formulation and process variables and to determine which studies were necessary to increase our knowledge”, the FDA wrote.
Specific examples include using design of experiments (DOE) to investigate high-risk variables. By taking this step critical material attributes (CMAs) and critical process parameters (CPPs) can be determined.