Rules and Guidance for Pharmaceutical Manufacturers and Distributors. The Orange Guide

Bernan Assoc, 2002. — 352 p.Commonly known as the "Orange Guide", this publication brings together the main pharmaceutical regulations, directives and guidance, including GMP and GDP, which manufacturers and wholesalers are expected to follow when making and distributing medicinal products in the European Union and European Economic Area. This 2002 edition has been substantially updated to include annexes 15,16,17 and 18 to the EU guidelines in Good Manufacturing Practice including the ICH GMP for active pharmaceutical ingredients. It also covers revised annexes in the Guide to GMP on the manufacture of sterile products (annex one), medicinal gases (annex six) and on products derived from human blood or plasma (annex 14). The book provides an updated version of the UK's "Code of Practice for Qualified Persons" and an added section on the Inspection and Enforcement Division of the Medicines Control Agency including notes on mutual recognition agreements for manufacture, supply of unlicensed products and the services of the Division