ABSTRACT
Recently, the Food and Drug Administration (FDA) has begun to implement the current
Good Manufacturing Practice (cGMPs) for the 21st Century Initiative to further ensure
the availability of high quality pharmaceutical products in the Unites States market. The
initiative was first announced in 2002 and became clearly-defined in its final report
published in September 2004 (1). The centerpiece of this initiative is to rely on science-
based and risk-based approaches to FDA regulatory decision-making throughout the
entire lifecycle of a product. The guiding principles for implementing this cGMPs ini-
tiative are outlined in Figure 1. Based on these principles, the quality of pharmaceutical
products is established through an efficient utilization of modern pharmaceutical
development, quality risk management, and quality systems. With the advances in sci-
ence and engineering in the 21st century, the modern knowledge and information can be
readily applied to improve the efficiency and effectiveness of both manufacturing process
and regulatory actions. The implementation of the cGMPs initiative is also coordinated
with other international regulatory authorities through the development of harmonized
guidelines and strategies. These science-based and risk-based efforts can lead to the
global implementation of a more efficient quality-assurance system for pharmaceutical
manufacturing and regulatory oversight and thus provide the most effective public health
protection.
