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作者 Singer, Donald C
書名 Laboratory Quality Handbook of Best Practices and Relevant Regulations
出版項 Milwaukee : ASQ Quality Press, 2000
國際標準書號 (electronic bk.)
說明 1 online resource (387 pages)
text txt rdacontent
computer c rdamedia
online resource cr rdacarrier
附註 Intro -- 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 -- 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 -- Appendix G FDA Good Laboratory Practices for Nonclinical Lab Studies -- Bibliography -- Index
Description based on publisher supplied metadata and other sources
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2020. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries
鏈接 Print version: Singer, Donald C. Laboratory Quality Handbook of Best Practices and Relevant Regulations Milwaukee : ASQ Quality Press,c2000 9780873894913
主題 Laboratories -- Quality control -- Handbooks, manuals, etc.;Laboratories -- Law and legislation -- Handbooks, manuals, etc
Electronic books
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