A Laboratory Quality Handbook of Best Practices

Front Cover
Donald C. Singer
ASQ Quality Press, 2001 - Science - 404 pages
1 Review
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. from sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance.
 

What people are saying - Write a review

We haven't found any reviews in the usual places.

Contents

OutofSpecification Results
267
FDA Guide for Investigating OutofSpecification Test Results
285
III Inspections
299
An FDA Approach to Laboratory Inspections
301
FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories
315
FDA Guide to Inspections of Microbiological Quality Control Laboratories
329
IV An International Perspective
337
Accreditation and Harmonization
339

Laboratory Equipment Qualification
185
Equipment Calibration and Maintenance
205
Laboratory Water and Water Purification Systems
217
Methods Validation
225
ICH Guidelines on Validation of Analytical Procedures
249
Additional Appendices
355
The OECD Principles of Good Laboratory Practice
357
FDA Good Laboratory Practices for Nonclinical Lab Studies
377
Index
395
Copyright

Other editions - View all

Common terms and phrases

Bibliographic information