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History of the Orange Guide

March 12, 2012

Dominic Parry

Pharmaceutical manufacturing sites in the UK will be more than familiar with the “Orange Guide”.  This British publication has for decades contained the requirements of Good Manufacturing Practice.  This article provides a brief overview of the history of this book and also covers why it is certainly no longer a guide.

First published in 1971 the original Orange Guide contained British Good Manufacturing Practice and was entitled “Guide to Good Pharmaceutical Manufacturing Practice”.  Not much more than 30 pages in length this voluntary guide was an aid to manufacturers to understand the needs of the regulatory authority’s requirements for the manufacture of pharmaceutical products.

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