Guide for the Assessment of Clotting Factor Concentrates

APPENDIX 3GLOSSARYBatch release testing: Testing of end products by regulatory authorities before official release toensure that the product specification is met.Characterization: Analytical measurements which allow detailed understanding of the compositionand other attributes of a product.Donor screening: Individual donations of blood are screened to ensure that blood-borne viruses donot enter the plasma pool. Screening is currently available for HBV, HCV, and HIV.Donor selection: Procedures designed to identify and exclude donors at risk of being infected withviruses that can be transmitted by blood transfusion.Enveloped/lipid enveloped viruses: The common transfusion transmitted viruses HIV, HCV, andHBV, which are all characterized by a lipid viral envelope and are highly infectious.Finished product testing: Testing done on final product to allow manufacturers to characterize theirproducts and to demonstrate compliance of every batch with the licensed specification.Fractionation: The process of separating and processing human blood plasma into a range of productsfor therapeutic use.Good manufacturing practices (GMPs): All the elements in established practice that will collectivelylead to final products that consistently meet expected requirements as reflected in product specification.These include traceability, segregation of product manufacturing steps to avoid cross-contamination,training, documentation, change control, and deviation reporting.Inventory hold: The retention in storage of plasma for fractionation while processes designed toassure donor safety are undertaken.Limit testing: Testing of the plasma pool using nucleic acid testing (NAT) in which a maximum levelof viral contamination, rather than an absolute elimination, is the aim.Lyophilization: The process of isolating a solid substance from solution by freezing the solution andevaporating the ice under vacuum. Freeze-drying.Marketing authorization: The formal permit from a regulatory authority allowing a manufacturer tomarket a product following that authority's scrutiny.Minipools: Plasma samples pooled from several donations, and then tested for viral markers.Nanofiltration: A process whereby protein solutions are passed over small pore filters which canremove viruses while allowing therapeutic proteins to pass through.Non-enveloped /non-lipid enveloped viruses: Pathogenic viruses (for example, HAV or parvovirusB19) which lack a lipid envelope and therefore are not susceptible to viral inactivation techniques suchas solvent-detergent treatment.Guide for the Assessment of Clotting Factor Concentrates 47