PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (Inspection Guide)
This Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (“Inspection Guide”) lays down principles for GMP inspections of source plasma establishments and of source plasma warehouses. Most of the plasma imported to the EU or PIC/S Member States actually comes from the United States of America. Therefore, the Inspection Guide also takes into consideration the particular situation in U.S. facilities.
The Inspection Guide provides also basic information on GMP requirements, specific for source plasma establishments and for plasma warehouses. As in general the same GMP criteria are applicable for the storage of plasma in smaller facilities (e.g. a source plasma establishment with a freezer) and in bigger facilities (e.g. a central plasma warehouse with freezing rooms), the plasma storage requirements as defined in the Inspection Guide apply to both kind of facilities if not otherwise indicated. The document does not include plasma