Biomedical Engineering Reference
In-Depth Information
6
APPLICATION OF QbD
PRINCIPLES TO TANGENTIAL
FLOW FILTRATION OPERATIONS
Peter K. Watler and John Rozembersky
6.1 INTRODUCTION
The concepts of Quality by Design (QbD) and design space have been stressed in
recent U.S. and international regulatory publications including “Pharmaceutical cGMPs
for the twenty-first century” [1, 2], “Guidance for Industry—PAT” [3], “Quality Risk
Management” [4], “Pharmaceutical Development” [5], “Annex to Pharmaceutical
Development” [6], and “Standard Guide for Specification, Design, and Verification of
Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment” [7].
The concept of QbD is quite straightforward and as explained byMohebNasr of the FDA,
it simply involves “doing the right thing,” taking “a good scientific approach,” and “using
good science” [8]. In essence, QbD involves employing the fundamentals of the scientific
approach and using common sense. The main benefit of the knowledge gained from
employing QbD is to enhance “the quality of pharmaceuticals” [8]. Furthermore, the
greater process understanding and optimal operation of unit operations “will result in
cost benefits for the industry.” Finally, with a detailed understanding of the process, firms
will see that “regulatory flexibility is an added benefit”; however, as Nasr notes, this is not
the main driver for initiating QbD efforts.
