Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017
The Orange Guide
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Pharmaceutical Press
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.
New content includes:
Qualification of suppliers and customers
Parallel importation and parallel distribution
Temperature control and monitoring
GMP for excipients
Guidance on revised Annex 16 of GMP
Data Integrity definitions and guidance for industry
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
This title supersedes the 2015 edition, ISBN 9780857111715, published 06 Jan 2015.
|Size||244 x 172mm||Price||£80.00|
|Format||Paperback||Published||06 Jan 2017|
|Availability||Available to order: 2 – 3 weeks||Delivery||Delivery options and charges|