000			01249nam a22001697a 4500
008			211202b |||||||| |||| 00| 0 eng d
020			_a9780857112859
020			_a 0857112856
110			_a Medicines & Healthcare Products Regulatory Agency _926003
245			_aRules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
250			_a 10th Edition, revised
260			_a66-68 East Smithfield, London E1W 1AW, UK _b Pharmaceutical Press _c2017
300			_a 816 pages
520			_aAnnotation 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.
654			_xDrugs
942			_2ddc _cEB
999			_c3180 _d3180