The new EU GDP Guidelines was published on March 7, 2013 with an implementation period of six months until September 8, 2013. A new version of the Guidelines was published on 23rd November, 2013 for corrections of text and translation errors. More ...
Monday, November 30, 2015
Twenty years ago, the risk to drug substance/product quality due to
temperature excursions during shipping was not generally appreciated.
A series of studies led to several papers in USP PF which documented
some of the risks1-4. In response, ...
It has been more than one year ago that the new EU GDP Guidelines came into enforced implementation. It is an improvement and a step forward over the previous 1994 Guidance as the new one better reflects the various changes in the distribution ...