SCOPE

The scope of this chapter is limited to the virus testing performed on human plasma for the further manufacture of pharmaceuticals, which are referred to as plasma-derived products (see Virology Test Methods 〈1237〉 for virus testing of other therapeutic products). These types of plasma include either source plasma collected by apheresis or recovered plasma obtained from whole blood collection or as a byproduct in the production of blood components. In all cases, the source material is obtained through voluntary donations. The following topics are specifically excluded from the scope of this chapter:

• Virus testing of nonhuman blood or plasma; for example, fetal bovine serum (see Bovine Serum 〈1024〉 for more information on testing this material), which may be used in the production of biological or recombinant therapeutics

• Virus testing of human-derived whole blood, blood components used for transfusion, and materials in tissue and organ banks

• Testing for nonviral organisms; for example, bacteria, fungi, and parasites (some of these topics are discussed in Sterility Tests 〈71〉), or the causative agent of transmissible spongiform encephalopathy.