
Quality
Description
Key Features
- Fully revised, updated, and expanded new edition
- Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools
- Includes end-of-chapter summaries and end-of-chapter question and/or problems
- Provides detailed steps and examples for applying the guidelines and quality tools
- Written in an accessible style making the content easy to understand and apply
Readership
Pharmaceutical Manufacturing companies: managerial and supervisory levels; QPs; Bioprocess companies: managerial and supervisory levels; QPs Pharmaceutical Certification Organizations; Industry associations; Technical and academic libraries; Industry training bodies; FDA, EMA, PMDA, WHO, and other governmental agencies
Table of Contents
1. Product Life Cycle
2. Good Manufacturing Practice
3. Elements of Quality Management
4. Quality Systems and International Standards
5. The Management of Quality
6. Inspections and Auditing
7. Quality Improvement Programmes
8. Corrective and preventive actions
9. Calibration
10. Validation
11. Technology Transfer
12. Water for Pharmaceutical Use
13. Pharmaceutical Microbiology
14. Good Distribution Practice
Product details
- No. of pages: 362
- Language: English
- Copyright: © Butterworth-Heinemann 2022
- Published: July 15, 2022
- Imprint: Butterworth-Heinemann
- Paperback ISBN: 9780323908153