Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017: Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers & Distributors (Orange Guide))

Commonly known as the Orange Guide, this book provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines. Annotation This is the tenth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by MHRA. Commonly known as the Orange Guide, it 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. The new 2017 edition has been updated to incorporate changes and additions made to the detailed European Community guidelines on Good Manufacturing Practice (GMP) and the revised EU Guidelines on Good Distribution Practice (GDP), including Annexes 15 and 16 Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, 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 contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation. Changes in this new 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 contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation Commonly known as the Orange Guide, this book is an essential reference for all involved in the manufacture or distribution of medicines in Europe.