Validation and qualification in analytical laboratories / Ludwig Huber.
By: Huber, Ludwig
.
Material type: 
BookPublisher: New York : Informa Healthcare, c2007Edition: 2nd ed.Description: v, 303 p. : ill. ; 24 cm. + hbk.ISBN: 9780849382673 ; 084938267X .Subject(s): Chemistry, Analytic -- Quality control | Chemical laboratories -- StandardsDDC classification: 543.0685 | Item type | Current library | Call number | Copy number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|---|
| General Lending | MTU Bishopstown Library Lending | 543.0685 (Browse shelf(Opens below)) | 1 | Available | 00169584 |
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Enhanced descriptions from Syndetics:
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 serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.
Includes bibliographical references (p. 281-297) and index.
Introduction -- Regulations, standards, and guidelines -- Terminology and validation overview -- Risk-based validation and qualification -- Master and project planning for equipment and computer systems -- Design qualification -- Installation qualification -- Operational qualification -- Performance qualification and maintenance -- Special considerations for software and computer systems -- Validation of analytical methods -- Data review and validation and evaluation of uncertainty -- Handling out-of-specification situations -- (Certified) reference standards -- People -- Proficiency testing for external laboratory qualification -- Audits.
CIT Module CHEM 8004 - Supplementary reading
Table of contents provided by Syndetics
- Preface (p. iii)
- 1 Introduction (p. 1)
- 2 Regulations, Standards, and Guidelines (p. 9)
- 3 Terminology and Validation Overview (p. 25)
- 4 Risk-Based Validation and Qualification (p. 37)
- 5 Master and Project Planning for Equipment and Computer Systems (p. 55)
- 6 Design Qualification (p. 63)
- 7 Installation Qualification (p. 71)
- 8 Operational Qualification (p. 81)
- 9 Performance Qualification and Maintenance (p. 93)
- 10 Special Considerations for Software and Computer Systems (p. 109)
- 11 Validation of Analytical Methods (p. 125)
- 12 Data Review and Validation and Evaluation of Uncertainty (p. 155)
- 13 Handling Out-of-Specification Situations (p. 165)
- 14 (Certified) Reference Standards (p. 179)
- 15 People (p. 189)
- 16 Proficiency Testing for External Laboratory Qualification (p. 209)
- 17 Audits (p. 215)
- Appendix A Glossary (p. 229)
- Appendix B OQ Tests for Selected Equipment (p. 243)
- Appendix C Selected (Standard) Operating Procedures (p. 259)
- Appendix D Books in the Area of Qualification and Validation (p. 281)
- Appendix E References (p. 291)
- Index (p. 299)