New edition of the “Orange guide” now available from the Pharmaceutical Press
 After more than 35 years as a Stationary Office publication, the “Orange guide”, an essential reference work for manufacturers and distributors of medicines, is now available in a new edition published by the Pharmaceutical Press (the imprint of the Royal Pharmaceutical Society’s publishing operation).
The book concerned is “Rules and guidance for pharmaceutical manufacturers
and distributors”, published since 1971 and always generally known
as the “Orange guide”. For the first time, the guide is also
available digitally on CD-ROM and online via MedicinesComplete, the RPS
Publishing online database resource.
Compiled by the inspection and standards division of the Medicines and
Healthcare products Regulatory Agency, the guide collates in one source
European and UK guidance documents and information on legislation relating
to the manufacture and distribution of medicines for human use. Changes
in the new edition include detailed amendment to the EU guide to good
manufacturing practice, detailed revisions to the EU directive on medicinal
products for human use and the inclusion of the new directive laying
down the principles and guidelines of good manufacturing practice in
respect of medicinal products for human use.
The new edition also has restructured contents, clearer text design and
a subject index.
The 448-page paperback book costs £40. A singe-user CD-ROM costs £47.
UK orders can be placed by telephone (01767 604971), fax (01767 601640)
or e-mail (rps@turpin-distribution.com) or through the Pharmaceutical
Press website
An official launch of the new edition will be held at the MHRA’s
London premises on 23 February.
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