Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms

This Example is from April 2012 and covers Module 3 3.2.P.2 Pharmaceutical Development - any changes up to now?


This is an example pharmaceutical development report illustrating how ANDA applicants can move toward implementation of Quality by Design (QbD). The purpose of the example is to illustrate the types of pharmaceutical development studies ANDA applicants may use as they implement QbD in their generic product development and to promote discussion on how OGD would use this information in review.

Although we have tried to make this example as realistic as possible, the development of a real product may differ from this example. The example is for illustrative purposes and, depending on applicants’ experience and knowledge, the degree of experimentation for a particular product may vary. The impact of experience and knowledge should be thoroughly explained in the submission. The risk assessment process is one avenue for this explanation. At many places in this example, alternative pharmaceutical development approaches would also be appropriate.


Notes to the reader are included in italics throughout the text. Questions and comments may be sent to GenericDrugs@fda.hhs.gov

Pharmaceutical Development Report Example QbD for IR Generic Drugs
Example QbD IR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development
April 2012
QbD IR Final April 2012-508-Final2.pdf
Adobe Acrobat Document 1.5 MB