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 learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations. 

 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.