Amgen Manufacturing Ltd. - Jan. 23, 2015

The current procedures for the monitoring of the environmental conditions in the drug-product aseptic production and the drug-substance production areas do not always establish/include and/or require sample collections which could provide a more accurate and/or more thorough assessment on the microbiological quality and/or condition of the aseptic-filling operation and drug-substance production areas and/or surfaces that are monitored as part of these procedures.