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Introduction to the Good Laboratory Practice Regulations

Abstract

The GLP Regulations provide the framework for performing scientifically valid studies and generating reliable safety data. Complying with these regulations is a complex process. The veterinary and animal care staff has a key role in supporting these studies.

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References

  1. 21 CFR, Chapter 1, Part 58—Good Laboratory Practice for Nonclinical Laboratory Studies. http://www.access.gpo.gov/nara/cfr/waisidx_04/ 21cfr58_04.html.

  2. 40 CFR, Part 160—Good Laboratory Practice Standards. http://www.ovpr.uga.edu/qau/epaglp_a.html.

  3. 40 CFR, Part 792—Good Laboratory Practice Standards, Toxic Substances Control Act. http://www.ovpr.uga.edu/qau/tscatoc.html.

  4. Organisation for Economic Co-operation and Development. Principles of Good Laboratory Practice. http://www.oecd.org/env/glp.

  5. Japan Society of Quality Assurance. GLP Standard (Japan). http://www.jsqa.com/en/index.html.

  6. US Food and Drug Administration. Compliance Program Guidance Manual. Chapter 48—Bioresearch Monitoring. http://www.fda.gov/ora/compliance_ref/bimo/7348_808/48-808.pdf.

  7. US Food and Drug Administration. Guidance for Industry: Computerized Systems Used in Clinical Trials. http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.pdf.

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Correspondence to Joe Cwiertniewicz RQAP-GLP, CQA.

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Cwiertniewicz, J. Introduction to the Good Laboratory Practice Regulations. Lab Anim 34, 29–32 (2005). https://doi.org/10.1038/laban0305-29

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  • DOI: https://doi.org/10.1038/laban0305-29

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