Since the 2002 edition of 'Rules and Guidance for Pharmaceutical Manufacturers and Distributors', commonly known as the 'Orange Guide', there have been many changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP). In addition, there is a new Directive dealing specifically with GMP and the Community Code relating to medicinal products for human use (Council Directive 2001/83/EC) has itself been the subject of substantial revision, via amending Directive 2004/27/EC, and these changes have been transposed into UK domestic legislation.
From its first publication in 1971 the 'Orange Guide', has been an essential reference for all involved in the manufacture and distribution of medicines in Europe.
The 'Orange Guide' collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Compliance with Good Manufacturing Practice and Good Distribution Practice requirements is essential in the production and distribution of medicines for human use to safeguard public health and to comply with legislation.
It is of particular relevance to all holders of Manufacturer’s Licences and Wholesale Dealer’s licences and to their Qualified Persons and Responsible Persons, who have a responsibility for ensuring compliance with many of these regulatory requirements.
Changes to the 2007 edition include:
'Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007' is published by and available from Pharmaceutical Press.
c/o Macmillan Distribution Ltd (MDL)
Telephone: 01256 302692
Fax: 01256 812558 / 812521
Web: Pharmaceutical Press (external link)
The Orange Guide is also available online via MedicinesComplete. Visit the MedicinesComplete website (external link) or email email@example.com for more information.