Pharmaceutical Business Technical Standards

Author: Duan Yuxin
Publisher:
Publish Date: 2003-03-01
Features: This book focuses on introducing the technical standards for the operation of traditional Chinese medicine (TCM), Western medicine, medical devices, and the processing of TCM decoctions, totaling more than 730 standards. It is of great significance for strengthening pharmaceutical management, accelerating the GSP certification process for pharmaceutical enterprises, and quickly aligning with international practices. It serves as a reference for pharmaceutical-related enterprises and professionals.
[Preface]
Preface With the rapid development of China's pharmaceutical industry, technological advancements, and China's entry into the WTO, the globalization of the pharmaceutical economy has become inevitable. Pharmaceutical enterprises are facing both favorable development opportunities and severe challenges. In accordance with the requirements of the National Food and Drug Administration to expedite the GSP certification process for the "Good Supply Practice," based on current domestic and international pharmaceutical trends, and in line with China's GBT/10300 standards, ISO-9000 series standards, the "Pharmaceutical Administration Law," the "Implementation Rules of the Pharmaceutical Administration Law," and relevant pharmaceutical regulations, as well as the 2000 edition of the "Pharmaceutical Compendium of the People's Republic of China," this technical standard has been developed in conjunction with the characteristics of pharmaceutical enterprises. It emphasizes the reinforcement of technical standards and quality systems, ensuring unified, standardized, and orderly management, guided by the principles of "scientific, advanced, standardized, and clear." This technical standard is divided into six parts: TCM, Western medicine, medical devices, TCM decoctions production, and others, totaling more than 730 standards.
This technical standard considers both the existing foundation of pharmaceutical enterprises and the requirements for pharmaceutical quality and GSP standards, so some aspects of the standards are set higher than the current status of the enterprises. Pharmaceutical enterprises need to actively create conditions and combine practical circumstances to strengthen pharmaceutical management, promote the rapid development of China's pharmaceutical industry, and quickly align with international practices.
The compilation of the "Pharmaceutical Technical Standards" was reviewed and supported by Liu Xiaohuan, Assistant Director of the Hebei Provincial Food and Drug Administration, and Xu Ping of Shijiazhuang Pharmaceutical Company. The author expresses deep gratitude for their contributions! During the writing process, references were made to China's relevant pharmaceutical regulations as of September 15, 2002, and the specialized standards of relevant industries, as well as the works of various authors. Due to space constraints, the references are not listed one by one in the bibliography. The author sincerely apologizes for any omissions or shortcomings in the book and welcomes readers' criticism and corrections.