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Rules and Guidance for Pharmaceutical Manufacturers and Distributors

Rules and Guidance for Pharmaceutical Manufacturers and Distributors
Publisher:Pharmaceutical Press; Rev Ed edition( 27 April 2007) | ISBN-10: 0853697191 | PDF | 9.3 Mb | 430 pages

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.

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