Modern Pharmaceutical Industry Microbiology Laboratory Quality Management and Validation Technology

Author: Pan Youwen
Publisher:
Publish Date: 2004-04-01
Features: Without management, there can be no quality. Whether each control measure, inspection method, and the status and performance of every piece of equipment are effective, accurate, and reliable must be confirmed through appropriate monitoring methods and scientific, reasonable verification experiments. Therefore, management plus verification is the essence of GMP and the core content of this book. This book is divided into three parts and nineteen chapters, systematically elaborating on the quality management of microbial laboratories, primarily focusing on the regulations of microbial laboratories, including management requirements for experimental facilities and equipment, reference standards, microbial strains, reagents, culture media, disinfectants, as well as documents, personnel training, deviations, changes, and quality audits. The second part emphasizes the microbial control and validation of inspection methods in the biopharmaceutical industry's production processes, mainly covering the control and verification technologies of cleanrooms (areas) in biopharmaceutical industries, sterile isolation systems, sterilization and pyrogen removal processes, sterile production processes, pharmaceutical water systems, microbial testing (sterility testing, microbial limit testing methods, etc.), and the integrity of sterile drug seals. The third part introduces the new developments in microbial control and analysis in the biopharmaceutical industry, mainly including microbial identification, trend analysis of data, statistical process control, and the theory and practice of parameter release for sterilized products.