ABSTRACT
This chapter outlines the relationship between the individual process (equipment) failure mode and effects analysis (FMEA) and the products produced. Each manufacturing area has a table that aligns the process FMEAs required for each product type. This is completed for all manufacturing areas: component preparations, filling, sterilization, and packing. In order to assess manufacturing risks for site manufacturing/production equipment processes, FME s are created and documented. These FMEAs for components, filling, and packing production areas are generated as per requirements. The combination of various area FMEAs provides the overall risk assessments by product type. All classified environments in which intermediate and final products are manufactured or manipulated, including the storage of components and solutions and the product itself, have been evaluated per Environmental FMEAs. Environmental FMEAs are used as part of the overall environmental monitoring program.
