M MIREGMGR Feb 19, 2015 #21 Feb 19, 2015 #21 Any such gap analysis probably would have been done to 11135:2007, which isn't the latest ISO version and is no longer recognized by FDA. 550 was withdrawn by ISO on 2007-08-01. It's been a long time since it was FDA accepted.
Any such gap analysis probably would have been done to 11135:2007, which isn't the latest ISO version and is no longer recognized by FDA. 550 was withdrawn by ISO on 2007-08-01. It's been a long time since it was FDA accepted.