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{ "item_title" : "Good Pharmaceutical Manufacturing Practice", "item_author" : [" John Sharp "], "item_description" : "Bridging the gap between U.S. cGMP Regulations and European GMP guidelines, this book presents the major substance of both the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use(EU GMP guide). Drawing on more than forty years of experience, the author explores the reasoning behind the requirements. Topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in an international capacity.", "item_img_path" : "https://covers2.booksamillion.com/covers/bam/0/84/931/994/0849319943_b.jpg", "price_data" : { "retail_price" : "280.00", "online_price" : "280.00", "our_price" : "280.00", "club_price" : "280.00", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }
Good Pharmaceutical Manufacturing Practice|John Sharp

Good Pharmaceutical Manufacturing Practice : Rationale and Compliance

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Overview

Bridging the gap between U.S. cGMP Regulations and European GMP guidelines, this book presents the major substance of both the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use(EU GMP guide). Drawing on more than forty years of experience, the author explores the reasoning behind the requirements. Topics include personnel, documentation, premises and equipment, production, quality control, self-inspection, recalls, and more. This is an essential guidebook for those who wish to expand their pharmaceutical business in an international capacity.

This item is Non-Returnable

Details

  • ISBN-13: 9780849319945
  • ISBN-10: 0849319943
  • Publisher: CRC Press
  • Publish Date: October 2004
  • Dimensions: 10.3 x 7.16 x 1.28 inches
  • Shipping Weight: 2.35 pounds
  • Page Count: 520

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