- 288 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
Validation and Qualification in Analytical Laboratories
About this book
This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title
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Table of contents
- Front cover
- Preface
- Contents
- Chapter 1. Introduction
- Chapter 2. Regulations, Standards, and Guidelines
- Chapter 3. Terminology and Validation Overview
- Chapter 4. Risk-Based Validation and Qualification
- Chapter 5. Master and Project Planning for Equipment and Computer Systems
- Chapter 6. Design Qualification
- Chapter 7. Installation Qualification
- Chapter 8. Operational Qualification
- Chapter 9. Performance Qualification and Maintenance
- Chapter 10. Speical Considerations for Software and Computer Systems
- Chapter 11. Validation of Analytical Methods
- Chapter 12. Data Review and Validation and Evaluation of Uncertainty
- Chapter 13. Handling Out-of-Specification Situations
- Chapter 14. (Certified) Reference Standards
- Chapter 15. People
- Chapter 16. Proficiency Testing for External Laboratory Qualification
- Chapter 17. Audits
- Appendix A: Glossary
- Appendix B: OQ Tests for Selected Equipment
- Appendix C: Selected (Standard) Operating Procedures
- Appendix D: Books in the Area of Qualification and Validation
- Appendix E: References
- Index
- Back cover
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Yes, you can access Validation and Qualification in Analytical Laboratories by Ludwig Huber in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.