Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) 2014

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (The Orange Guide) 2014

Paperback Rules and Guidance for Pharmaceutical Manufacturers and Distributors

By (author) Great Britain: Medicines and Healthcare products Regulatory Agency

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  • Publisher: Pharmaceutical Press
  • Format: Paperback | 640 pages
  • Dimensions: 172mm x 244mm x 28mm | 1,225g
  • Publication date: 31 January 2014
  • Publication City/Country: London
  • ISBN 10: 0857111027
  • ISBN 13: 9780857111029
  • Edition: 8, Revised
  • Edition statement: Revised edition
  • Illustrations note: illustrations (colour)
  • Sales rank: 120,962

Product description

Familiarly known as the "Orange Guide," this title is an essential reference work for all those involved in the manufacture or distribution of medicines in or for Europe. It is compiled by the UK drug regulatory body, the MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It therefore contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation.

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Table of contents

Section 1: Medicines and Healthcare Products Regulatory Agency (MHRA); Section 2: Guidance on Good Manufacturing Practice (GMP); Section 3: Legislation on Manufacture; Section 4: Guidance on Wholesale Distribution Practice; Section 5: Legislation on Wholesale Distribution; Section 6: Glossary of Legislation