Good Laboratory Practice The Why and the How

After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other "test items" with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scien...

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Bibliographic Details
Main Author: Seiler, Jürg P.
Format: eBook
Language:English
Published: Berlin, Heidelberg Springer Berlin Heidelberg 2001, 2001
Edition:1st ed. 2001
Subjects:
Online Access:
Collection: Springer Book Archives -2004 - Collection details see MPG.ReNa
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505 0 |a I. What is Good Laboratory Practice All About ? -- 1. Introduction -- 2. The History of GLP -- 3. The Idea Behind GLP -- 4. The Areas of Application -- 5. The Pillars of Good Laboratory Practice -- 6. Where Can GLP be Profitably Applied ? -- 7. GLP and Other Laboratory Quality Systems -- II. How is Good Laboratory Practice Regulated ? -- 1. Introduction -- 2. Definitions in GLP -- 3. Responsibilities in Good Laboratory Practice -- 4. The Quality Assurance Programme -- 5. Facilities -- 6. Apparatus, Materials and Reagents -- 7. Computerised Systems -- 8. Test Systems -- 9. Test and Reference Items -- 10. Standard Operating Procedures -- 11. Study Performance and Reporting -- 12. The Archives -- Appendix II.I -- Appendix II.II -- Appendix II.III -- Appendix II.IV -- III. How can Good Laboratory Practice be Introduced in a Test Facility? -- 1. Introduction -- 2. General Aspects -- 3. A General Way to Implementation -- IV. How is Compliance with Good Laboratory Practice Monitored ? -- 1. Introduction -- 2. National Monitoring Authorities -- 3. MOUs, MRAs, and MJVs -- Appendix IV.I -- Appendix IV.II -- References -- Useful Internet Addresses 
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520 |a After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other "test items" with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field tests or ecotoxicology studies. At the same time the term "Good Laboratory Practice" has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work