Rules and guidance for pharmaceutical manufacturers and distributors 2002
Author(s)
Bibliographic Information
Rules and guidance for pharmaceutical manufacturers and distributors 2002
TSO, 2002
6th ed
Available at 2 libraries
  Aomori
  Iwate
  Miyagi
  Akita
  Yamagata
  Fukushima
  Ibaraki
  Tochigi
  Gunma
  Saitama
  Chiba
  Tokyo
  Kanagawa
  Niigata
  Toyama
  Ishikawa
  Fukui
  Yamanashi
  Nagano
  Gifu
  Shizuoka
  Aichi
  Mie
  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
  China
  Thailand
  United Kingdom
  Germany
  Switzerland
  France
  Belgium
  Netherlands
  Sweden
  Norway
  United States of America
Note
Also known as the "Orange Guide"
Description based on 5th impression, 2005
Includes index
Description and Table of Contents
Description
Commonly known as the "Orange Guide", this publication brings together the main pharmaceutical regulations, directives and guidance, including GMP and GDP, which manufacturers and wholesalers are expected to follow when making and distributing medicinal products in the European Union and European Economic Area. This 2002 edition has been substantially updated to include annexes 15,16,17 and 18 to the EU guidelines in Good Manufacturing Practice including the ICH GMP for active pharmaceutical ingredients. It also covers revised annexes in the Guide to GMP on the manufacture of sterile products (annex one), medicinal gases (annex six) and on products derived from human blood or plasma (annex 14). The book provides an updated version of the UK's "Code of Practice for Qualified Persons" and an added section on the Inspection and Enforcement Division of the Medicines Control Agency including notes on mutual recognition agreements for manufacture, supply of unlicensed products and the services of the Division
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