This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives.
Key Features
- Reviews various scientific and regulatory aspects involved in the quality control of biologicals
- Provides overview and roles of various national and international regulatory bodies and accreditation agencies
- Presents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes
- Explores use of animal-based testing methods in quality control, as well as their alternatives
- Discusses guidel
