This book provides much-needed practical information on how to generate and review data for regulatory consideration in the biotech, pharmaceutical, and life science industries. It explains in detail how to develop and implement effective strategies for meeting technical challenges, Good Laboratory Practice (GLP) and GxP requirements from global perspectives, with an emphasis on tools and techniques for ensuring the quality and integrity of study data.

Readers will gain invaluable insight into the entire hardware and software qualification process as well as people qualification, learn how to get through laboratory audits and inspections with ease, and acquire a thorough understanding of all regulatory issues relevant to their work. 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 GxP quality systems

• Facility and personnel infrastructure and qualification

• Techniques for modern bioanalytical / 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 so on

• Important laboratory applications of Ligand Binding Assays (LBAs) andbiomarker assays

A must-have for scientists, graduate students, and quality assurance managers in bioanalytical laboratories, Regulated Bioanalytical Laboratories is also an essential reference for anyone interested in the overall technical know-how, regulatory, and quality assurance trends in the field.