Medicinal Products GMP Brief Tutorial

Author: Li Zhining / Li Jun (editors)
Publisher:
Publish Date: 2003-02-01
Features: Good Manufacturing Practice (GMP) for pharmaceuticals is the fundamental principle for pharmaceutical production and quality management. The pharmaceutical production requirements demand that all employees of the enterprise must have a strong GMP awareness and quality concept. This book serves as an introductory textbook for GMP learning, comprising four parts and 17 chapters, explaining China's GMP (revised in 1998) through a combination of narrative and Q&A. The Basic Part elaborates on and answers related questions about the legal foundation of GMP (mainly the Pharmaceutical Administration Law) and the scientific foundation (mainly the Quality Management System Standards). The General Principles Part and the Specific Elements Part discuss the general principles and each element of GMP, while the Certification Part briefly introduces the content of pharmaceutical GMP certification. The book is rich in content yet concise, with language that is easy to understand. It is suitable for all-employee training in pharmaceutical enterprises and can also serve as a reference for faculty and students of secondary and higher medical and pharmaceutical colleges, as well as other relevant personnel.