The tenth edition of the orange guide has been published
The tenth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by MHRA. Commonly known as the Orange Guide has been published.
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.