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

 
9780857111029: Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2014

Synopsis

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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From the Back Cover

This eighth edition of the text commonly known as "The Orange Guide" remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines. Since the 2007 edition there have been significant changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP) as well as substantial amendments to the Community code relating to medicinal products for human use. This new edition covers these important changes as well as featuring: Changes to the EU Guide on GMP, including the addition of Part III Revised EU Guide for good distribution practice Revisions to the EU Directive on medicines for human use New chapters for brokers of finished medicines and manufacturers, importers and distributors of active substances as a result of Falsified Medicines Directive 2011/62/EU Updated chapters on the work of the MHRA Extracts from the UK's consolidated human medicines legislation New appendix of names and addresses of other EU medicines regulators.With restructured contents and index and a fresh design the new edition of The Orange Guide offers easy navigation of these important changes. Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.Available online at www.medicinescomplete.com

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Medicines and Healthcare Products Regulatory Agency
Published by Pharmaceutical Press, 2014
ISBN 10: 0857111027 ISBN 13: 9780857111029
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Paperback. Condition: Very Good. This book is in very good condition and will be shipped within 24 hours of ordering. The cover may have some limited signs of wear but the pages are clean, intact and the spine remains undamaged. This book has clearly been well maintained and looked after thus far. Money back guarantee if you are not satisfied. See all our books here, order more than 1 book and get discounted shipping. Seller Inventory # 6545-9780857111029

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Paperback. Condition: Very Good. Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2014 This book is in very good condition and will be shipped within 24 hours of ordering. The cover may have some limited signs of wear but the pages are clean, intact and the spine remains undamaged. This book has clearly been well maintained and looked after thus far. Money back guarantee if you are not satisfied. See all our books here, order more than 1 book and get discounted shipping. Seller Inventory # 7719-9780857111029

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Medicines and Healthcare Products Regulatory Agency
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ISBN 10: 0857111027 ISBN 13: 9780857111029
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Condition: Very Good. 8 PAP/PSC. Ships from the UK. Former library book; may include library markings. Used book that is in excellent condition. May show signs of wear or have minor defects. Seller Inventory # GRP83386137

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Condition: Good. Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions. Seller Inventory # Z1-F-009-02031

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Condition: Good. This is an ex-library book and may have the usual library/used-book markings inside.This book has soft covers. In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,1350grams, ISBN:9780857111029. Seller Inventory # 9252809

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unkown. Condition: Very Good. The Orange Guide; 7 X 1.25 X 9.25 inches; 640 pages. Seller Inventory # 7b1-65

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