Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms Introduction to the Example This is an example pharmaceutical development report illustrating how ANDA sponsors can move toward implementation of quality by design (QbD). The example builds on acetriptan tablets (ACE) case study by treating that product as the reference product for the development of a generic product. The purpose of the example is to illustrate the types of pharmaceutical development studies ANDA sponsor may use as they implement QbD in their development process and promote discussion on how OGD would use this information in review. Although we have tried to make the 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 a firms experience and prior knowledge the degree of experiments for a particular product may vary. The impact of experience and prior knowledge should be 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. This example illustrates one of many possible approaches. Notes to the reader are included in italics at the beginning of many sections and throughout the text. DRAFT Example QbD IR Tablet Module 3 Quality 3.2.P.2 Pharmaceutical Development 2Pharmaceutical Development Report Example QbD for IR Generic Drugs Draft April 26, 2011 Table of Contents 1.1 Overview................................................................................................................................... 4 1.2 Analysis of the Reference Listed Drug (RLD) Product..........................
