Table Displaying Detection Methods and Assessments
| Sub-Factors | Description and Reason | Weighting/Score | |
|---|---|---|---|
| Detection | Room environmental monitoring | Room environmental monitoring, when examined over time for trends, can provide a medium detection level provided that the sample locations are meaningful. This acts as a general indicator of quality. | Low detection |
| In-process sample test and room environmental monitoring | In-process samples, which are representative of the processed product, provide a direct assessment of the quality of the material. Accordingly such tests represent high detection methods. In addition, the room environmental monitoring indicated above is also performed. | Medium detection | |
| In-process sample test, room environmental monitoring, and a monitored water for injection (WFI) outlet | In addition to the room environmental monitoring and in-process tests, the presence of a WFI outlet affords an additional detection method. WFI is assessed as part of a biweekly roster. | High detection |