Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017
The Orange Guide
MHRA (Medicines and Healthcare products Regulatory Agency)
Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK
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.
Comprehensive new content includes:
• qualification of suppliers and customers
• parallel importation and parallel distribution
• temperature control and monitoring
• UK legislation
• unlicensed medicines
There are new MHRA sections on:
• GMP for excipients
• guidance on revised Annex 16 of GMP
• data Integrity definitions and guidance for industry
Plus new Commission guidance on:
• principles and guidelines of GMP for active substances
• principles of GDP of active substances
• setting health based exposure limits
• formalised risk assessment for ascertaining the appropriate GMP for excipients.
The work includes EU regulation on safety features for medicines, along with two Commission Q&As on the importation of active substances and safety features for medicinal products.
A new appendix on sources of useful information has also been added.
The Orange Guide is essential reading for anyone subject to MHRA inspection, providing you with all the answers you need to stay informed.
It is compiled by the Inspection, Enforcement and Standards Division, MHRA, London, UK [www.gov.uk/mhra].