Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives covers the development and implementation strategies for routine, non-routine, and standard bioanalytical methods 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.

Coverage includes:

• International standards and regulations from the US FDA, USP, ICH, OECD, WHO, ISO EMEA, and EU
• Requirements, objectives and implementation of GLP and HxP quality systems
• Facility and personnel infrastructure and qualification
• Techniques for modern bioanalyticsl/analytical sample preparation and essential concepts in extraction chemistry and separation mechanisms
• Specific strategies for the efficient use of laboratory automation with high throughput
• instrumental analysis for hyphenated techniques such as LC-MS/MS and son on
• Important laboratory applications of Ligand Binding Assays (LBAs) and biomarker assays

Contents

1. Introduction, Objectives, and Key Requirements for GLP Regulations
2. Historic Perspectives of GLP Regulations, Applicability, and Relation to Other Regulations
3. GLP Quality System and Implementation
4. Fundamental Elements and Structures for Regulated Bioanalytical Laboratories
5. Technical and Regulatory Aspects of Bioanalytical Laboratories
6. Competitiveness of Bioanalytical Laboratories—Technical and Regulatory Perspectives
7. Sponsor and FDA/Regulatory Agency GLP Inspections and Study Audits
8. Current Strategies and Future Trends
9. General Terminologies of GxP and Bioanalytical Laboratories

Appendices

1. Generic Checklist for GLP/GXP Inspections/Audits
2. General Template for SOP
3. Typical SOPs for GLP/Regulated Bioanalytical Laboratory
4. Basic Equipment/Apparatus for Bioanalytical Laboratory
5. Website Linkages for Regulated Bioanalysis

Index

click here to see books of related interest