Good laboratory practice regulations by Sandy Weinberg

By Sandy Weinberg

This paintings covers all elements of the meals and Drug Administration's sturdy Laboratory perform relgulations and strategies for implementation. This variation contains normal wisdom on machine procedure validation, info on enforcing GIPs in an automatic laboratory, a forecast of the pliability and effectiveness of GLPs within the altering laboratory atmosphere, and a modern bibliography with new references.

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The requirement to analyze the test and control article/ carrier mixture. The necessity to utilize instruments that are maintained, calibrated, and standardized. SANDY WEINBERG Page vii Contents Preface iii Contributors ix Chapter 1 Historical Perspective Jean M. Taylor and Gary C. Stein 1 Chapter 2 FDA/GLP Regulations Wendell A. Peterson 23 Chapter 3 EPA and Foreign Country GLP Regulations Carl R. Morris and Frederick G. Snyder 111 Page viii Chapter 4 Implementing GLPs in a non-GLP Analytical Laboratory Barbara N.

17) EPA agreed with the FDA that many GLP provisions could be amended to incorporate the changes that had been made by the FDA. In addition, the scope of the Page 19 FIFRA regulations was expanded to include environmental testing provisions that already existed in the TSCA GLPs, and to include product performance data (efficacy testing). The EPA also proposed to expand the scope of the TSCA GLP regulations to include field testing. The EPA received 14 comments on its proposed GLP provisions, most of them supportive of the agency's proposed changes.

As a result of its own monitoring of GLP compliance, EPA agreed that its own GLP regulations could be streamlined without compromising the integrity of data submitted to the agency. The EPA's proposed revisions to its FIFRA and TSCA GLP regulations were issued on December 28, 1987. (17) EPA agreed with the FDA that many GLP provisions could be amended to incorporate the changes that had been made by the FDA. In addition, the scope of the Page 19 FIFRA regulations was expanded to include environmental testing provisions that already existed in the TSCA GLPs, and to include product performance data (efficacy testing).

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