A great companion to Book 4, this spiral-bound, 8-1/2" x 11" book is a compilation of preambles to GMP regulations 21CFR parts 11, 210 and 211. 

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 Manufacturing Practice Regulations.

What's the Price?
• 1-249 copies:  $24.95             • 250-499 copies:  $23.95
• 500-749 copies: $22.95          • 750+ copies:  $21.95

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 21 CFR Part 11
• Electronic Records/Signatures (62 FR 13429, March 20, 1997)

• Preambles to 21 CFR Parts 210 and 211
• Current Good Manufacturing Practice in Manufacture,
   Processing Packaging, or Holding: Proposed Rule
   (41 FR 6878, February 13, 1976)

• Current Good Manufacturing Practice in Manufacture,
   Processing, Packing, or Holding (43 FR 45014,
   September 29, 1978)

• Human and Veterinary Drug Products; Exemption From
   Expiration Dating and Stability Testing Requirements for
   Allergenic Extracts (46 FR 56411, November 17, 1981)

• Tamper-Resistant Packaging Requirements for Certain
   Over-the-Counter Human Drug and Cosmetic Products
   (47 FR 50442, November 5, 1982)

• Reduction of Reserve Sample Requirements for
   Radioactive Drugs (48 FR 13024, March 29, 1983)

• Tamper-Resistant Packaging Requirements for Certain
   Over-the-Counter Human Drug and Cosmetic Products
   (48 FR 16658, April 19, 1983)

• Adverse Drug Experience Reporting Requirements for
   Marketed Prescription Drugs Without Approved New Drug
   or Abbreviated New Drug Applications (51 FR 24476,
   July 3, 1986)

• Tamper-Resistant Packaging Requirements for Certain
   Over-the-Counter (OTC) Human Drug Products
   (54 FR 5227, February 2, 1989)

• Proposed Revision of Certain Labeling Controls
   (54 FR 26394, June 23, 1989)

• Proposed Amendment of Certain Requirements for Finished
   Pharmaceuticals (56 FR 5671, February 12, 1991)

• Revision of Certain Labeling Controls (58 FR 41348,
   August 3, 1993)

• Amendment of Certain Requirements for Finished
   Pharmaceuticals (60 FR 4087, January 20, 1995)

• Tamper-Evident Packaging Requirements for Over-
   the-Counter Human Drug Products (63 FR 59463,
   November 4, 1998)

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