Definition
GLPs: Are the legal requirements delineated by the FDA in 21 CFR Part 58 governing testing laboratories to ensure the quality of nonclinical laboratory studies related to safety of regulated health care products.
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Following incidents of scientific fraud and laboratories not following their protocols in drug testing, the FDA issued Good laboratory Practices in December 1978 as 21 CFR Part 58 (Major Revision 1987) to govern nonclinical safety studies for food, drugs, and medical devices. The US Environmental Protection Agency adopted two sets of GLPs in 1979 as part of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which was codified as 40 CFR part 160, and as part of the Toxic Substances Control Act (TSCA), codified as 40 CFR 792. In 1980, the Organization for Economic Cooperation and Development (OECD, http://www.oecd.org) also issued a set of international GLPs (revised in 1997) applicable to nonclinical safety studies,...
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References
Guidance documents at http://www.FDA.gov
OECD principles of good laboratory practice, ENV/MC/CHEM(98)17
Seiler JP (2001) Good laboratory practice: the why and the how. Springer, New York
Weinberg S (2003) Good laboratory practice regulations, 3rd edn. Marcel Dekker, New York
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© 2015 Springer-Verlag Berlin Heidelberg
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Michiel, D.F. (2015). Good Laboratory Practices. In: Schwab, M. (eds) Encyclopedia of Cancer. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-27841-9_2478-2
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DOI: https://doi.org/10.1007/978-3-642-27841-9_2478-2
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Publisher Name: Springer, Berlin, Heidelberg
Online ISBN: 978-3-642-27841-9
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