Good Manufacturing Practice for Drugs

Author: Zhu Shibin
Publisher:
Publish Date: 2001-07-01
Features: Medicines are a special kind of commodity, directly related to the life safety of the people. Their quality requirements are stricter than those of other products. Medicine production is a relatively complex process, involving many links such as raw material selection, entry, production, inspection, and qualification. It involves many aspects, including personnel, buildings, facilities, equipment, processes, inspection, and production and quality management, making it a systematic engineering. Negligence in any one link can affect the quality of the medicine. GMP is a set of standardized management methods summarized from the theory of quality management and systematic engineering in medicine production. The engineering of medicine production quality management is a science that studies how to implement GMP, how to transform the principle requirements of GMP into specific operational processes, and how to use pharmaceutical, engineering, management, and related scientific theories and technical means to specifically control various factors affecting medicine quality in production to ensure that the quality of the medicine is flawless. This book is organized by the Training Center of the National Medical Products Administration, with contributions from domestic GMP experts. The book is divided into two parts: Basic Principles and Practical Implementation. It comprehensively introduces modern quality management knowledge, ISO series standards, international GMP development trends, GMP requirements for buildings, facilities, and equipment, production management, quality management, validation, pharmaceutical water systems, filtration, and other practical GMP processes. Finally, it introduces the special requirements for injectable powder drugs in the implementation of GMP. This book is suitable for engineering and technical personnel in pharmaceutical enterprises engaged in production, management, and GMP-related work as a reference, and can also serve as a professional textbook for undergraduate and graduate students in pharmaceutical engineering.