The Site Master File for Source Plasma Establishments (SMF – SPE) refers to the PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (PI 008) and should be read in close conjunction to it; relevant terminology can be found there. It is based on the information given in the PIC/S document PE 008.
The SMF – SPE should be completed by the manufacturer. In case of more than on choosing the correct boxes should be marked and missing entries should be filled in. Hand-written entries must be easily legible (use printed / block letters). Numerical data should refer to a calendar year.
In order to provide actual information the SMF – SPE should be completed not earlier than approximately six (6) weeks prior to the inspection