Completely revised and expanded, this up-to-date sourceassists in the assessment of laboratory procedures in preparation for an external auditorreflects the impact of computers and information technologies on data generation, analysis, and storageoffers a global perspective on laboratory management and quality controlserves as a comprehensive guide to the design of an effective audit for enhanced laboratory operation
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
Table of Contents
Introduction. Quality and Auditing. Quality Control and Quality Assurance in a Laboratory. The Regulated Industries. Goals of a Laboratory Quality Audit. Audit Tools : Observation, Working Knowledge and Audit Documents. Non-Technical Parameters for Evaluation. Quality Programs, Organizational Structure and Documentation. Personnel. Facility and Environment. Technical Parameters for Evaluation. Sample Control. Instrumentation. Automation of Analytical Process. Acquisition and Processing of Data. Uncertainty of Measurements. Reliability of Measurements. Standards and Standardisation. Supplies Organization. Proficiency Testing. Other Areas to Consider. Customer Satisfaction. Laboratory Health and Safety. Communications and Follow-Up. Closing Conference, Final Report, and Follow-Up. Frequency of Audit. Epiloge. Appendices. Sample Laboratory Quality Audit Document. National Voluntary Laboratory Accreditation Program, NIST Handbook 150. Guide To Quality In Analytical Chemistry (Eurachem/CITAC). Quality Assurance of Research and Development and Non-routine Analysis (Eurachem/ CITAC). Accreditation for Microbiological Laboratories (Eurachem/EA). EPA Manual for Certification of Laboratories Analyzing Drinking Water. Federal Register (FDA): Good Laboratory Practice Regulations for Nonclinical Laboratory Studies. Bibliography
--Drug Development and Industrial Pharmacy