FDA's on-site inspection of cGMP in the United States

Author: Jiang Wan
Publisher:
Publish Date: 2007-01-01
Features: The current Good Manufacturing Practice (CGMP) is not only a scientific system and advanced technology adopted by pharmaceutical companies in North America to ensure drug product quality, but more importantly, it represents the advanced management concepts and methods of these companies. For Chinese pharmaceutical enterprises, establishing and improving CGMP systems and passing on-site inspections by the U.S. Food and Drug Administration (FDA) are crucial prerequisites for entering the international pharmaceutical market. This book provides a detailed discussion of the specific requirements and implementation details of CGMP in various functional departments of pharmaceutical companies from the perspective of production processes in North American pharmaceutical enterprises. Through examples, it combines the specific operational procedures that companies follow in daily work to comply with CGMP with the requirements of FDA on-site inspections for discussion. The numerous examples in this book not only provide rich hand resources for Chinese raw material and drug manufacturers in implementing and improving CGMP, but also introduce pharmaceutical companies to the conventional procedures and key areas of FDA CGMP on-site inspections. This includes the scope and requirements of FDA routine annual inspections and the strategies and policies companies should adopt to execute routine annual inspections, enabling Chinese pharmaceutical enterprises to gain a comprehensive understanding of the FDA on-site inspection process and a deeper insight into the full implementation of CGMP. Additionally, the eleven chapters of this book, along with the various references cited and examples listed, can serve as excellent teaching materials and reference resources for pharmaceutical companies to conduct CGMP training for their employees.