Good Manufacturing Practice and Quality Control for Biologics

Author: Zhou Guojia / Tang Qiaoying (Editor-in-Chief)
Publisher:
Publish Date: 2004-04-01
Features: This book begins with the origin, evolution, and development of biologic products, focusing on their important role in disease prevention, treatment, and diagnosis. It provides a detailed and systematic explanation of quality management procedures, standards, basic requirements, and Good Manufacturing Practices (GMP) for biologic products. The book also covers key points in the production processes and quality management of various biologic products, laboratory quality testing for different types of biologic products, vaccines and immune responses, serological and epidemiological evaluation of vaccine efficacy, adverse reactions to biologic product immunization and their monitoring, as well as important measures to strengthen quality control and management of biologic products. Additionally, it discusses the current status and future development of biologic products and modern biotechnology products. The content of the book is comprehensive, rich, and highly practical and instructive. It is suitable for technicians, researchers, and professionals engaged in the research, production, and management of biologic and biotechnology products as reference material. It can also be used as teaching and learning material for faculty and students in relevant higher education institutions.