Regulated bioanalytical laboratories : technical and regulatory aspects from global perspectives /

• Κύριος συγγραφέας: Zhou, Michael
• Συγγραφή απο Οργανισμό/Αρχή: Wiley InterScience (Online service)
• Μορφή: Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Hoboken, N.J. : Wiley, [2011]
• Θέματα: Medical laboratories > Quality control.; Biological laboratories > Quality control.; Pharmaceutical technology > Quality control.; Biological laboratories > Qualtiy control.; Medical laboratories > Qualtiy control.; Pharmaceutical technology > Qualtiy control.; MEDICAL > Instruments & Supplies.; Electronic books.

This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers lea...

Πίνακας περιεχομένων:

• Introduction, Objectives, and Key Requirements for GLP Regulations
• Historic Perspectives of GLP Regulations, Applicability, and Relation to Other Regulations
• GLP Quality System and Implementation
• Fundamental Elements and Structures for Regulated Bioanalytical Laboratories
• Technical and Regulatory Aspects of Bioanalytical Laboratories
• Competitiveness of Bioanalytical Laboratories--Technical and Regulatory Perspectives
• Sponsor and FDA/Regulatory Agency GLP Inspections and Study Audits
• Current Strategies and Future Trends
• General Terminologies of GxP and Bioanalytical Laboratories
• Appendix A: Generic Checklist for GLP/GXP Inspections/Audits
• Appendix B: General Template for SOP
• Appendix C: Typical SOPs for GLP/Regulated Bioanalytical Laboratory
• Appendix D: Basic Equipment/Apparatus for Bioanalytical Laboratory
• Appendix E: Website Linkages for Regulated Bioanalysis.