Glossary

A bacterial episome that confers the ability to function as a genetic donor in conjugation; the fertility factor in bacteria.

Federal Aviation Administration (U.S. Department of Transportation)

Walls, ceilings, floors, etc., that constitute the enclosure for process operations.

Finance and Audit Committee (ISPE term)

Federal Advisory Committee Act

(NEBB) The velocity obtained by dividing the air quantity by the component face area.

The intended use of a facility, e.g., dedicated, multi-use, multi-purpose.

A qualitative measure of the number of different products that can be produced in a facility or area of a facility.

The end user of a facility, often called the Owner, represented by operating, maintenance, and quality personnel.

Fluorescent-Activated Cell Sorting

In the clotting of blood, also known as Christmas factor (Biggs and Macfarlane). Deficiency of factor IX causes hemophilia B or Christmas disease that resembles hemophilia A and is an inherited defect that leads to a severe hemorrhagic disorder. Factor IX is required for the formation of intrinsic blood thromboplastin and affects the amount formed (rather than the rate).

In the clotting of blood, Factor VIII is a labile protein of the blood-clotting system that assists in the conversion of Factor IX into plasma factor X (Stuart factor). Deficiency of factor VIII is associated with classic hemophilia A, a hereditary, sex-linked, hemorrhagic tendency that occurs almost exclusively in men; clotting time is prolonged, less thromboplastin is formed, and the conversion of prothrombin is diminished.

The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricator’s site.

(IEEE) An Acceptance Test in the Supplier’s factory, usually involving the Customer.

Inspection and static and/or dynamic testing of systems or major system components to support the qualification of an equipment system conducted and documented at the supplier site.

A co-enzyme important in various biochemical reactions. It comprises a phosphorylated vitamin B2 (riboflavin) molecule linked to the nucleotide adenine monophosphate (AMP). It functions as a hydrogen acceptor in dehydrogenation reactions, being reduced to FADH2. This in turn is oxidized to FAD by the electron transport chain, thereby generating ATP (two molecules of ATP per molecule of FADH2).

After Gabriel Daniel Fahrenheit (1686-1736). Of or pertaining to a temperature scale that registers the freezing point of water as 32°F. and the boiling point as 212°F. under standard atmospheric pressure (29.921 inches of mercury). Fahrenheit temperatures are related to Centigrade temperatures by the equation F = 1.8C + 32

(IEEE) A system or component that automatically places itself in a safe operational mode in the event of a failure.

(IEEE) The inability of a system or component to perform its required functions within specified performance requirements.

Determining the exact nature and location of a program error in order to fix the error, to identify and fix other similar errors, and to initiate corrective action to prevent future occurrences of this type of error.