Regulatory Compliance and Product Risk
SPAH STEP has been successfully reviewed by FDA. It is engineered to comply with cGMP as it meets or supersedes ISPE Baseline Guidelines on Good Engineering Practice (GEP). Again, one key point found in independent research* is that modifying the building shell of a pharmaceutical facility could have a major impact on cost while having a minimal impact on product quality / risk. Users adopting SPAH STEP would be assured that SPAH STEP will have an insignificant impact, if any, on its product integrity.
*Please refer to independent research palette