Download PDF by Sandy Weinberg: Good laboratory practice regulations

By Sandy Weinberg

ISBN-10: 0824793773

ISBN-13: 9780824793777

This paintings covers all elements of the nutrients and Drug Administration's solid Laboratory perform relgulations and strategies for implementation. This variation comprises normal wisdom on machine approach validation, information on imposing GIPs in an automatic laboratory, a forecast of the pliability and effectiveness of GLPs within the altering laboratory setting, and a latest bibliography with new references.

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Gary C. D. , Boothwyn, Pennsylvania The Problem in the 1970s FDA's Perspective The Federal Food, Drug and Cosmetic Act (FFDCA) places the responsibility for establishing the safety and efficacy of human and veterinary drugs and devices and the safety of food and color additives on the sponsor of the regulated product. The Public Health Service Act requires that a sponsor establish the safety and efficacy of biological products. These laws place on the Food and Drug Administration (FDA) the responsibility for reviewing the sponsor's test results and determining whether the results establish safety and efficacy of the product.

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Good laboratory practice regulations by Sandy Weinberg

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