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Validation of Active Pharmaceutical Ingredients
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Validation of Active Pharmaceutical Ingredients Hardcover - 2001 - 2nd Edition

by Ira R. Berry (Editor); Daniel Harpaz (Editor)


From the publisher

Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.

First line

The subjects of Good Manufacturing Practice (GMP) and validation are not new to the pharmaceutical industry (Berry and Nash 1993; Tetzlaff et al. 1993; Berry 1988; Reisman 1995; Agalloco 1995; FDA 1987, 1994a, 1993a; Tetzlaff 1992a, 1992b; Tetzlaff 1993; Harpaz 1996; Amer 2000).

Details

  • Title Validation of Active Pharmaceutical Ingredients
  • Author Ira R. Berry (Editor); Daniel Harpaz (Editor)
  • Binding Hardcover
  • Edition number 2nd
  • Edition 2
  • Pages 618
  • Volumes 1
  • Language ENG
  • Publisher CRC Press
  • Date 2001-12-31
  • ISBN 9781574911190 / 1574911198
  • Weight 2.68 lbs (1.22 kg)
  • Dimensions 10.35 x 7.07 x 1.37 in (26.29 x 17.96 x 3.48 cm)
  • Library of Congress Catalog Number 00143894
  • Dewey Decimal Code 615.19
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Validation Of Active Pharmaceutical Ingredients 2Ed
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Validation Of Active Pharmaceutical Ingredients 2Ed
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