Administering Files, Records, and Grants
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Glossary.docxGlossary
The definitions given below apply to the terms used in these Recommendations. They may have different meanings in other contexts.
Apheresis
Procedure whereby blood is removed from the donor, separated by physical means into components and one or more of them returned to the donor.
Blood collection
Procedure whereby a single donation of blood is collected in an anticoagulant and/or stabilizing solution, under conditions designed to minimize microbiological contamination of the resulting donation.
Blood component
A constituent of blood (erythrocytes, leukocytes, platelets or plasma) that can be prepared under such conditions that it can be used either directly or after further processing for therapeutic applications.
Blood establishment
Any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and for their processing, storage, and distribution when intended for transfusion.[footnoteRef:1] [1: A blood centre is a blood establishment.]
Donor
A person who gives blood or plasma used for fractionation.
Factor VIII
Blood coagulation factor VIII, defi cient in patients with haemophilia A. Also called antihaemophilic factor.
Factor IX
Blood coagulation factor IX, defi cient in patients with haemophilia B.
First-time tested donor
A person whose blood or plasma is tested for the fi rst time for infectious disease markers in a blood establishment.
Fractionation
A (large-scale) process by which plasma is separated into individual protein fractions, that are further purifi ed for medicinal use (variously referred to as plasma derivatives, fractionated plasma products or plasmaderived medicinal products). The term fractionation is used to describe a sequence of processes, including: plasma protein separation steps (typically precipitation and/or chromatography), purifi cation steps (typically ionexchange or affi nity chromatography) and one or more steps for the inactivation or removal of blood-borne infectious agents (most specifi cally viruses and, possibly, prions).
Fractionator
A company or an organization performing plasma fractionation to manufacture plasma-derived medicinal products.
Genome equivalents (GE)
The amount of nucleic acid of a particular virus assessed using nucleic acid testing.
Good Manufacturing Practice (GMP)
Hepatitis A virus (HAV)
A non-enveloped, single-stranded RNA virus, causative agent of hepatitis A.
Hepatitis B surface antigen (HBsAg)
The antigen on the periphery of hepatitis B virus.
Hepatitis B virus (HBV)
An enveloped, double-stranded DNA virus, causative agent of hepatitis B.
Hepatitis C virus (HCV)
An enveloped, single-stranded, RNA virus, causative agent of hepatitis C.
Hepatitis E virus (HEV)
A non-enveloped, single-stranded RNA virus, causative agent of hepatitis E.
Hepatitis G virus (HGV) (or GB virus C (GBV-C))
An enveloped single-stranded RNA virus, causative agent of hepatitis G.
Human immunodefi ciency virus (HIV)
An enveloped, single-stranded RNA virus, causative agent of acquired immunodefi ciency syndrome (AIDS).
Incidence
The rate of newly-acquired infection identifi ed over a specifi ed time period in a defi ned population.
Inventory hold period
Period during which the plasma for fractionation is on hold pending identifi cation and elimination of possible window-phase donations.
Intravenous immunoglobulin (IVIG)
Also known as immune globulin, intravenous.
Look-back
Procedure to be followed if it is found retrospectively that a donation from a high-risk donor should have been excluded from processing.
Manufacture
All operations of procurement of materials (including collection of plasma for fractionation) and products; production; quality control; release; storage; distribution; and quality assurance of plasma-derived medicinal products.
Nucleic acid testing (NAT)
A method to detect viral genome that uses amplifi cation techniques such as polymerase chain reaction.
National regulatory authority
WHO terminology for referring to national medicines regulatory authorities. Such authorities promulgate medicines regulations and enforce them.
Plasma
The liquid portion remaining after separation of the cellular elements from blood collected in a receptacle containing an anticoagulant, or separated by continuous fi ltration or centrifugation of anticoagulated blood in an apheresis procedure.
Plasmapheresis
Procedure in which whole blood is removed from the donor, the plasma is separated from the cellular elements and at least the red blood cells are returned to the donor.
Plasma products
A range of medicinal products (as listed in Appendix 1) obtained by the process of fractionation of human plasma. Also called plasma derivatives, fractionated plasma products, or plasma-derived medicinal products.
Plasma for fractionation
Recovered plasma or source plasma used for the production of plasma products.
Plasma master fi le
A document which provides all relevant detailed information on the characteristics of the entire human plasma used by a fractionator as starting material and/or raw material for the manufacture of subintermediate or intermediate plasma fractions, constituents of the excipient and active substance(s), which are part of a medicinal product.
Prevalence
The rate of infection identifi ed, including both past and present infections, at a specifi ed point in time or over a specifi ed time period in a defi ned population.
Prion
The infectious particle associated with transmissible spongiform encephalopathies. It is believed to consist only of protein and to contain no nucleic acid.
Production
All operations involved in the preparation of plasma-derived medicinal products, from collection of blood or plasma, through processing and packaging, to its completion as a fi nished product.
Recovered plasma
Plasma recovered from a whole blood donation and used for fractionation.
Repeat-tested donor
A person whose blood or plasma has been tested previously in the blood establishment for infectious disease markers.
Replacement donor
Person who gives blood upon request of a specifi c patient or patient’s family or acquaintance, which in principle is intended to be used specifi cally for the treatment of that patient.
SD-plasma
Solvent/detergent-treated pooled plasma intended as a substitute for fresh frozen plasma (FFP).
Serious adverse event
Any untoward occurrence associated with the collection, testing, processing, storage and distribution of blood and blood components that might lead to death or life-threatening, disabling, or incapacitating conditions for patients or which results in, or prolongs, hospitalization or morbidity.
Serious adverse reaction
An unintended response in a donor associated with immunization that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalization or morbidity.
Source plasma
Plasma obtained by plasmapheresis for further fractionation into plasma products.
Traceability
Ability to trace each individual unit of blood or blood component derived thereof from the donor to its fi nal destination, whether this is a recipient, one or more batches of medicinal product or disposal. The term is used to describe both forward tracing (donation to disposition) and reverse tracing (disposition to donation).
TT virus (TTV)
A non-enveloped, single-stranded DNA virus, causing post-transfusion hepatitis of unknown etiology.
Viral inactivation
A process of enhancing viral safety in which the virus is intentionally “killed”.
Viral removal
A process of enhancing viral safety by removing or separating the virus from the protein(s) of interest.
West Nile virus (WNV)
An enveloped single-stranded RNA virus, causative agent of West Nile fever.
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