| Description |
1 online resource (314 pages) |
| 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. Special Considerations for Software and Computer Systems; Chapter 11. Validation of Analytical Methods |
|
Chapter 12. Data Review and Validation and Evaluation of UncertaintyChapter 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 Validat |
| Summary |
Explains how to improve pharmaceutical product quality while achieving compliance with global regulatory standards. This book provides guidance on qualification of certified standards and in-house reference materials and people qualification, as well as internal and third party laboratory audits and inspections |
| Notes |
Print version record |
| Subject |
Analytical chemistry -- Quality control
|
|
Chemical laboratories -- Standards
|
|
Analytical chemistry -- Quality control
|
|
Chemical laboratories -- Standards
|
| Form |
Electronic book
|
| ISBN |
9780849382680 |
|
0849382688 |
|
