Orange Guide

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (known as the Orange Guide), Medicines and Healthcare Products Regulatory Agency, published by the Stationery Office, 2002. 

The so-called orange guide, being Rules and guidance for manufacturers and distributors 1997 , provides guidance on GMP and GDP, and incorporates the directives and guidelines from the EU. 

The Medicines Inspectorate of the Medicines Control Agency enforces good manufacturing standards. The UK has been involved in the Pharmaceutical Inspection Convention since its inception and, through the Orange Guide, sets standards that are now reflected in the EU Directives. 

The Orange Guide, Rules and guidance for pharmaceutical manufacturers and distributors 1997 (London The Stationery Office). 

The need for higher standards of cleanliness and hygiene has already been mentioned. Since the safety factors for aseptic processes and terminal sterilisation processes rely on a low initial bioburden, attempts will continue to minimise contamination. Packaging manufacturers of materials, components and containers will therefore slowly adopt GMP procedures currently found as part of the Orange Guide in order to lower both bioburden and particulates. Cleanliness and improved hygiene are an order of the day, in terms of facilities, procedures and training. 

GMP is not simply the Orange Guide and the interpretation of it, but ongoing improvements in pharmaceutical quality. This means more control over the total packaging function and a greater use of computerised data, records and information. 

Table 3 compares the minimum filter efficiencies cited in the guidance documents on aseptic manufacturing and in the Clean Room Standards. It is curious that the specification for filter efficiency in the Orange Guide" is tighter than the specifications given in the two Clean Room Standards it refer-... 

Like the original U.K. guide to pharmaceutical GMP (the Orange Guide), the Blue Guide has no statutory force. 

Guide to Good Pharmaceutical Manufacturing Practice 1983. London, Her Majesty s Stationery Office, 1983 ("Orange Guide"). [Superseded by the 1992 EEC guide.]... 

The GMP directives were composed in the 1960s in the United States and a GMP guide was issued as the Orange Guide in the UK in 1971. In 1989 the GMP directives were introduced in Europe. They can be considered as a collection of instructions, warnings and recommendations that intends to minimise aU risks for the product and thereby guaranteeing constant yield and quality. It serves patient and manufacturer. 

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