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
- 288 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Validation and Qualification in Analytical Laboratories
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Information
Subtopic
Analytic ChemistryIndex
BusinessTable of contents
- Cover
- Half Title
- Title Page
- Copyright Page
- Preface
- Table of Contents
- 1. Introduction
- 2. Regulation, Standard, and Guideline
- 3. Terminology and Validation Overview
- 4. Risk-Based Validation and Qualification
- 5. Master and Project Planning for Equipment and Computer Sy tems
- 6. Design Qualification
- 7. Installation Qualification
- 8. Operational Qualification
- 9. Performance Qualification and Maintenance
- 10. Special Considerations for Software and Computer Systems
- 11. Validation of Analytical Methods
- 12. Data Review and Validation and Evaluation of Uncertainty
- 13. Handling Out-of-Specification Situations
- 14. (Certified) Reference Standards
- 15. People
- 16. Proficiency Testing for External Laboratory Qualification
- 17. Audit
- Appendix A
- Appendix B
- Appendix C
- Appendix D
- Appendix E
- Index
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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 Business & Analytic Chemistry. We have over one million books available in our catalogue for you to explore.