Assessment of Process Distance Hazard
| Hazard | Sub-Factors | Description and Reason | Weighting/Score |
|---|---|---|---|
| Distance from final formulation severity | Final formulation | The highest weighting has been afforded to rooms in which the final processing steps occur. | 3 |
| One step removed | Process steps which are close to the final formulation/final filtration step can also present a potential contamination risk to the product due to the limited number of process steps reaming. Consequently a high weighting has also been given to these rooms. | 3 | |
| Two steps removed | Rooms in which intermediate processing steps occur are considered to present a lower risk to the product manufacture due to subsequent process step occurring that might contribute to the reduction of bioburden and based on these process steps requiring less hygienic manufacturing. | 2 | |
| Three or more steps removed | Rooms that are three or more steps removed from final formulation/final filtration are generally those in which raw materials are handled, or they are nonprocess areas or wash-bays. In these rooms some level of bioburden is expected and a much lower weighting is assigned. | 1 |