Biomedical Engineering Reference
In-Depth Information
2
CONSIDERATIONS FOR
BIOTECHNOLOGY PRODUCT
QUALITY BY DESIGN
Steven Kozlowski and Patrick Swann
2.1 INTRODUCTION
In August 2002, the Food and Drug Administration (U.S. FDA) announced a significant
new initiative, pharmaceutical Current Good Manufacturing Practices (CGMPs) for the
twenty-first century [1]. This initiative is intended to enhance and modernize pharma-
ceutical manufacturing and product quality. Specific areas of focus include facilitating
industry adoption of risk-based approaches, technological advances, and modern quality
management techniques. As part of this initiative, the FDA will use state-of-the-art
pharmaceutical science in developing review, compliance, and inspection policies and
will coordinate these activities under a quality systems approach.
Concurrently with the CGMPs for the twenty-first century initiative, process
analytical technology (PAT), a system to improve pharmaceutical manufacturing was
being discussed at the advisory committee of the Office of Pharmaceutical Science at
CDER and at the FDA Science Board [2].
Process Analytical Technology is a system for designing, analyzing, and controlling
manufacturing through timely measurements (i.e., during processing) of critical quality
and performance attributes of rawand in-process materials and processes with the goal of
ensuring final product quality [3]. In 2004, the FDA published guidance on PAT [4] that
