| Description |
1 online resource (387 pages) |
| Contents |
Dedication -- Table of Contents -- Preface -- Acknowledgements -- I. Quality in the Laboratory -- 1 Quality Assurance in the Laboratory -- 2 History of Regulation and the Laboratory -- 3 An Overview of Key Parameters for Evaluating a Laboratory -- II. Critical Laboratory Operations -- 4 Training in the Laboratory -- 5 Laboratory Documentation and Data -- 6 Sample Control and LIM Systems -- Appendix A EPA Good Automated Laboratory Practices -- 7 Laboratory Equipment Qualification -- 8 Equipment Calibration and Maintenance -- 9 Laboratory Water and Water Purification Systems |
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10 Methods Validation -- Appendix B ICH Guidelines on Validation of Analytical Procedures -- 11 Out-of-Specification Results -- III. Inspections -- 12 An FDA Approach to Laboratory Inspections -- Appendix D FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories -- Appendix E FDA Guide to Inspections of Microbiological Quality Control Laboratories -- IV. An International Perspective -- 13 Accreditation and Harmonization -- Part V Additional Appendices -- Appendix F The OECD Principles of Good Laboratory Practice |
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Appendix G FDA Good Laboratory Practices for Nonclinical Lab Studies -- Bibliography -- Index |
| Notes |
Print version record |
| Subject |
Laboratories -- Quality control -- Handbooks, manuals, etc
|
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Laboratories -- Law and legislation -- Handbooks, manuals, etc
|
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Laboratories -- Law and legislation
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Laboratories -- Quality control
|
| Genre/Form |
Handbooks and manuals
|
| Form |
Electronic book
|
| ISBN |
9780873894913 |
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087389491X |
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