giovedì 22 marzo 2012
Orange guide - GMP
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.
Later editions followed in 1977 and 1983, these been more expansive with more detailed requirements for manufacturing sites. You could argue that the 1977 version was the last true Orange Guide as the 1983 version was entitled “Rules and Guidance for Pharmaceutical Manufactures”. In other words containing some “rules” in addition to “guidelines”. Others argue that the 1983 version was the last true Orange Guide, as this was the last publication containing British GMP.
In the late 1980’s and early 1990’s the European Union’s (EU) role in regulating pharmaceutical manufacturing sites was increasing and becoming more harmonised. In the early 1990’s EU Directive 91/356/EEC was signed. This removed different national GMPs from Europe into a single GMP for the whole of the European Union, and from this point onwards EU GMP was born. EU GMP was created using the leading two written GMPs of Europe at that time, namely those of the British and the French.
From the mid-1990 the UK’s Regulatory Authority continued to publish the “Orange Guide”, but it now contained EU GMP rather than British GMP. This is still the case today. In addition Good Distribution Practice (GDP) has also made its way into the book. The book was published again in 1997, 2002 and then 2007. As it is still published in a book with an orange cover the nick-name of the Orange Guide remains today. It now contains more than just GMP, with sections covering both UK and EU legislation on pharmaceuticals (so it is not just a guide) as well as Good Distribution Practice and Active Pharmaceutical Ingredients GMP, plus a lot more.
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