QbD in pharmaceuticals is a method whereby quality elements are evaluated using an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality.

Under the current development and manufacturing path for generic drugs, product quality and performance are predominantly determined by testing of the end product. Under the QbD system, quality is built into the final product by understanding and controlling formulation and manufacturing variables. End product testing is then used to confirm the quality of the product. The intention of using QbD is that consumers will receive a high quality product while manufacturers may have the ability to improve their process through manufacturing changes [1].

Although FDA is encouraging the implementation of QbD for all pharmaceutical products, there are unique issues in the application of QbD to generic products. To use QbD to develop a product that is bioequivalent to a reference product, a generics applicant must understand attributes of the formulation and manufacturing process that have the potential to change the bioavailability of a particular active ingredient.

FDA has already adopted question-based review in order to move abbreviated new drug applications (ANDAs) towards QbD. FDA is now speeding up the move to QbD for generics applications and says it is collaborating with the generics industry to prepare companies for the change.

To make it easier for generics manufacturers to comply with the changes and fully adopt QbD, FDA is developing ‘examples for immediate release dosage forms, as well as for modified release’, Mr Lawrence Yu, Deputy Director, Science and Chemistry, FDA, told in-Pharma Technologist.

FDA plans to fully implement QbD for ANDAs as of January 2013. Manufacturers of generics therefore have until then to understand and adopt QbD.

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Reference

1. Woodcock J. The concept of pharmaceutical quality. American Pharmaceutical Review November/December 2004:p106. Available from: http://americanpharmaceuticalreview.com/ArticleList.aspx?IssueID=3153&ContentTypeID=2