A Laboratory Quality Handbook of Best Practices and Relevant Regulations

by Singer, Donald C.

• ISBN13: 9780873894913
• ISBN10: 087389491X
• Format: Hardcover
• Copyright: 2001-04-01
• Publisher: Asq Pr

Table of Contents

Preface	vii
Acknowledgements	xi
Part I Quality in the Laboratory	1	(12)
Quality Assurance in the Laboratory	3	(2)
History of Regulation and the Laboratory	5	(4)
An Overview of Key Parameters for Evaluating a Laboratory	9	(4)
Part II Critical Laboratory Operations	13	(286)
Training in the Laboratory	15	(12)
Laboratory Documentation and Data	27	(12)
Sample Control and LIM Systems	39	(146)
EPA Good Automated Laboratory Practices	53	(132)
Laboratory Equipment Qualification	185	(20)
Equipment Calibration and Maintenance	205	(12)
Laboratory Water and Water Purification Systems	217	(8)
Methods Validation	225	(42)
ICH Guidelines on Validation of Analytical Procedures	249	(18)
Out-of-Specification Results	267	(32)
FDA Guide for Investigating Out-of-Specification Test Results	285	(14)
Part III Inspections	299	(38)
An FDA Approach to Laboratory Inspections	301	(36)
FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories	315	(14)
FDA Guide to Inspections of Microbiological Quality Control Laboratories	329	(8)
Part IV An International Perspective	337	(18)
Accreditation and Harmonization	339	(16)
Part V Additional Appendices	355	(40)
Appendix F The OECD Principles of Good Laboratory Practice	357	(20)
Appendix G FDA Good Laboratory Practices for Nonclinical Lab Studies	377	(18)
Index	395