A great companion to Book 9, this spiral-bound, 8-1/2" x 11" book is a compilation of preambles to GLP regulations 21CFR part 58. 

A preamble is the explanatory text that precedes a new or revised regulation when it is published by the federal government. Preambles provide important background information on a regulation such as:

• The reason(s) for the regulation or change in in the regulation
• The FDA's intent and interpretation of the regulation
• Industry's comments on the proposed regulation
• Reasons for modification from its proposed form to its final form

Who Uses this Book and How?
Anyone who wants a better understanding of the Good Laboratory Practice Regulations.

What's the Price?
• 1-249 copies:  $22.95             • 250-499 copies:  $21.95
• 500-749 copies: $20.95          • 750+ copies:  $19.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

• Preamble to PROPOSED GLP Regulations
   Federal Register, Vol. 41, No. 225,
   November 19, 1976

• Preamble to FINAL GLP Regulations
   Federal Register, Vol. 43, No. 247
   December 22, 1978

• Preamble to PROPOSED AMENDMENTS to GLP Regulations
   Federal Register, Vol. 49, No. 210
   October 29, 1984

• Preamble to FINAL AMENDMENTS to GLP Regulations
   Federal Register, Vol. 52, No. 172
   September 4, 1987

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