Laboratory Auditing for Quality and Regulatory Compliance,9781574445701

Laboratory Auditing for Quality and Regulatory Compliance

by ;
Edition: 1st
ISBN13: 9781574445701
ISBN10: 1574445707
Format: Hardcover
Pub. Date: 2005-07-25
Publisher(s): CRC Press
List Price: $170.00

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Summary

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.

Author Biography

Donald C. Singer is Global Lead Manager of PD Microbiological Services, GlaxoSmithKlin, Collegeville, Pennsylvania Raluca-Ioana Stefan is Senior Lecturer of Analytical and Bioanalytical Chemistry at the University of Pretoria, South Africa Jacobus F. van Staden is Full Eminent Professor and Head of Analytical Chemistry and Process Analytical Chemistry at the University of Pretoria, South Africa

Table of Contents

Preface iii
Introduction vii
Quality and Auditing
1(8)
Quality Control and Quality Assurance in a Laboratory
1(2)
The Regulated Industries
3(2)
Goals of a Laboratory Quality Audit
5(2)
Audit Tools: Observation, Working Knowledge, and Audit Documents
7(2)
Nontechnical Parameters for Evaluation
9(10)
Quality Programs, Documentation, and Organizational Structure
9(5)
Personnel
14(1)
Facility and Environment
15(4)
Technical Parameters for Evaluation
19(10)
Sample Control
19(1)
Instrumentation
20(2)
Automation of Analytical Process
22(1)
Acquisition and Processing of Data
23(1)
Uncertainty of Measurements
24(2)
Reliability of Measurements
26(1)
Standards and Standardization
26(1)
Supplies Organization
27(1)
Proficiency Testing
28(1)
Other Areas to Consider
29(2)
Customer Satisfaction
29(1)
Laboratory Health and Safety
29(2)
Communications and Follow-Up
31(4)
Closing Conference, Final Report, and Follow-Up
31(2)
Frequency of Audit
33(2)
Epilog
35(430)
Appendices
A. Sample Laboratory Quality Audit Document
37(14)
B. National Voluntary Laboratory Accreditation Program, NIST Handbook 150
51(66)
C. Guide to Quality in Analytical Chemistry (Eurachem/CITAC)
117(58)
D. Quality Assurance for Research and Development and Nonroutine Analysis (EURACHEM/CITAC)
175(54)
E. Accreditation for Microbiological Laboratories (Eurachem/EA)
229(24)
F. EPA Manual for Certification of Laboratories Analyzing Drinking Water
253(190)
G. Federal Register (FDA): Good Laboratory Practice Regulations for Nonclinical Laboratory Studies
443(22)
Bibliography 465(4)
Index 469

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