Good Manufacturing Practice Implementation Guide for Traditional Chinese Medicine Pieces

Author: Li Guangfu
Publisher:
Publish Date: 2005-08-01
Features: Under the circumstances that all Chinese herbal medicine preparation enterprises in our country will implement mandatory license certification before January 1, 2008, this book is compiled based on China's "Good Manufacturing Practice for Drugs" (Drug GMP, hereinafter referred to as GMP) (revised in 1998) and the "GMP Certification Inspection Items for Chinese Herbal Medicine Preparations" announced by the State Food and Drug Administration, as well as the practical experience of domestic Chinese herbal medicine preparation enterprises. This "guide" consists of four parts. Part I (Chapter) introduces the concept of Chinese herbal medicine preparations, the current status of Chinese herbal medicine preparation enterprises in our country, and how to implement GMP. The second part (Chapters 2 and 3) introduces the document management, organizational management, and personnel allocation of Chinese herbal medicine preparation enterprises implementing GMP. The third part (Chapters 4 to 13) provides document templates for implementing GMP based on the main provisions and content of GMP, offering enterprises options for transformation and implementation of GMP. This part includes factory and facilities, equipment, materials, sanitation, validation, production management, quality management, preparation sales and recall, complaints and adverse reaction reporting, and self-inspection. The fourth part (Chapter 14) introduces the main preparatory work that Chinese herbal medicine preparation enterprises should undertake to welcome GMP certification inspections. At the end of the book, there are five relevant regulations and provisions, including China's "Good Manufacturing Practice for Drugs" (revised in 1998) and the "GMP Certification Inspection Items for Chinese Herbal Medicine Preparations." The features of this "guide" are that it provides comprehensive and systematic examples and templates, all of which are derived from the GMP implementation materials of some preparation enterprises that have passed GMP certification, including relevant GMP systems, procedures, programs, standards, and related documents such as records, forms, accounts, and cards. It is highly standardized and operational. This "guide" can be used as a reference for the leaders, quality management personnel, R&D personnel, and hospital pharmacists of Chinese herbal medicine preparation enterprises, as well as for drug supervision personnel and students and teachers of relevant professional colleges and universities for study and reference. The book is divided into four parts. Part I introduces the concept of Chinese herbal medicine preparations; the second part introduces the document management of Chinese herbal medicine preparation enterprises implementing GMP; the third part provides document templates for implementing GMP; and the fourth part introduces the main preparatory work that Chinese herbal medicine preparation enterprises should undertake to welcome GMP certification inspections.