EU ANNEX 11

After the draft in 2008, the new Annex 11 to the European GMP for pharma products was published in 2011.

The new regulations about computerized systems became law on 2011, June 30^th. At the same time, even the Chapter n. 4 of the above mentioned European GMP (about documentation) was updated, both to make it congruent with the new Annex 11 and to introduce new subjects.

Read more: read the article about the EU Annex 11 update (ITA).