eBook - ePub
Quality Control and Regulatory Aspects for Biologicals
Regulations and Best Practices
- 204 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
About this book
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 an overview of the 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 the use of animal-based testing methods in quality control, as well as their alternatives
- Discusses guidelines and methodologies involved in the development of biological products
Overall, this book is an important reference source for various professionals in the pharmaceutical industry, including researchers, scientists, quality control personnel, and regulatory affairs professionals.
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Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Yes, you can access Quality Control and Regulatory Aspects for Biologicals by Gauri Misra in PDF and/or ePUB format, as well as other popular books in Medicine & Biomedical Science. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover
- Half-Title Page
- Title Page
- Copyright Page
- Dedication
- Table of Contents
- List of Figures
- List of Tables
- Preface
- List of Contributors
- 1 Regulatory Aspects of Quality Control in Pharmaceuticals
- 2 Importance of Quality Control in Biologicals
- 3 Role and Importance of National and International Agencies in Quality Control Regulation
- 4 Accreditations for Biologicals
- 5 Indian Industries and Biologicals
- 6 Animal-Based Testing Methods and Their Alternatives in Quality Control Evaluation of Biologicals
- 7 Good Manufacturing Practices in Quality Control
- 8 The Role of Analytical Methods in Quality Control of Biologicals and Stability Testing of Biological Products
- 9 Regulatory Bodies: European Medicines Agency (EMA) and Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
- 10 Quality Control Considerations Specific to the Development and Production of Gene and Cell Therapies
- Index