Authority News

11 April 2008 European Commission:
Public consultation on revisions of GMP Annex 11 on Computerized Systems and related changes in GMP Part I/ Chapter 4 on Documentation

The Annex has been updated in response to the increased use of computerised systems and the increased complexity of these systems. Consequential amendments are also proposed for Chapter 4 of the GMP Guide (Documentation).

Comments should be sent to entr-gmp@ec.europa.eu and GMP@emea.europa.eu by 31 October 2008.

GMP Annex 11 on Computerized Systems

GMP Part I/ Chapter 4 on Documentation