Abstract
D&MD' s Guide to Good Laboratory Practice, 3rd Edition examines the GLP
regulations in the United States and other countries in detail, and gives firm
guidelines for compliance, using as a basis the GLP requirements published in
the U.S.A Code of Federal Regulations, Title 21, Part 58, 2006 Edition
(21CFR58). The guidelines laid down by other countries, especially members of
the European Community, are based upon guidelines developed by the
Organization for Economic Development (OECD) in 1980. Guidelines on safety
testing and analytical methods issued by the International Conference on
Harmonization (ICH) are also reviewed. Special attention is paid to the
documentation and the preparations for internal and external inspections and
audits.
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