Further Reading and Resources
European Commission: Industry and Enterprise
- EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.
- EudraLex - Volume 10 Clinical trials guidelines
European Commission EudraLex Volumes 4 and 10 covering Good Manufacturing Practice and clinical trials are the most relevant for the study of the details of Good Manufacturing Practice regulation.
A brief history of the GMPs. For those interested in understanding the background within the USA, then this article first published in the Biopharm magazine in August 2000 entitled "A brief history of the GMPs" is essential reading and places all of the key regulations into context. The article was written by Barbara K. Immel.
Orange Guide – MHRA Site
Available in book form and CD (CD is fully searchable)
