Amgen Technology Ireland - April 2, 2015
Issue Date
Apr 02, 2015
Region
HQ
Category
Drug
$117.00
Contact Name
Kerry D. Ingalls
Contact Title
VP ADL Site Operations & VP of Regional Manufacturing
Address 1
Pottery Road
Address 2
Dun Laoghaire
City
Dublin
Country
Ireland
Inspection Range
Mar 26, 2015 - Apr 02, 2015
Pages
4
First Observation
There is a failure to conduct comprehensive reviews of the changes and additional software codes functionalities made to the Drug Product Filling Line and the revalidation of these software codes as necessary based on these reviews to assure that the ** filling line performs according to its CGMP software applications to prevent filling line non-conformance reoccurrences and to ensure that other software functionalities were not affected as the results of these additions.
Investigator(s): Omotunde O. Osunsanmi