Glossary

Good Pharmacovigilance Practice

Good Quality Practice

Applied to air cleanliness, “grade” implies airborne particle count limits in operation, with associated bioburden limits. The number of the grade is the upper limit in operation as defined by ISO 14644-1 (i.e., grade 5 has 0.5 micron upper particle limit of 3500/cubic meters). In the European GMP, Grades A through D also involve particle limits at rest.

A unit of weight: 1 grain equals 0.0648 g or 0.00143 lb.

For metals, the bounding surface between crystals. When alloys yield new phases (as in cooling), grain boundaries are the preferred location for the appearance of the new phase. Certain deterioration, such as season cracking and caustic embrittlement, occur almost exclusively at grain boundaries.

A unit of concentration. 1 grain/gal = 17.1 mg/l.

Concentration of dissolved ions in water, generally as calcium carbonate. 7,000 grains are equal to a pound. One grain per gallon is equivalent to 17.1 ppm of Dissolved Solids (as calcium carbonate).

A metric unit of mass. One U.S. ounce equals 28.4 grams; one U.S. pound equals 454 grams. There are 1000 milligrams (mg) in one gram.

A basic classification of bacterial type, along with “Gram positive”. These organisms resist straining by the Gram technique. Sometimes considered “bad” bacteria when discussing pollution or contamination; however, this is an artificial and quite broad classification.

Of bacteria, holding the color of the primary stainwhen treated with Gram’s stain.

A technique to distinguish between two major bacterial groups, based on stain retention by their cell walls. Bacteria are heat-fixed, then stained with crystal violet, followed by iodine solution, and then rinsed with alcohol or acetone.Gram-positive bacteria are stained bright purple, while Gram negative bacteria are decolorized.

Any prokaryotic organism that does not retain the first stain (crystal violet) used in Gram’s staining technique. It does retain the second stain (safranin O) and therefore has a pink color when viewed under a light microscope. Retention of the stain is due to the structure of the cell wall.

Any prokaryotic organism that does not retain the first stain (crystal violet) used in Gram’s staining technique. It does retain the second stain (safranin O) and therefore has a pink color when viewed under a light microscope. Retention of the stain is due to the structure of the cell wall.

Any prokaryotic organism that retains the first stain used in the Gram technique, which gives a purple-black color when viewed under a light microscope. Retention of the stain is due to the structure of the cell wall.

A technique for identification of bacteria developed by Hans Christian Gram in 1884, it indicates fundamental differences in the cell wall structure of bacteria. A differential test whereby organisms that accept Safranin stain are gram-negative (red), and organisms that react in crystal violet stain are gram positive (blue).

Financial support provided for research study designed and proposed by the principal investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant.

The process of collecting particles together by creating bonds between them. Bonds are formed by compression or by using a binding agent.

A mixture of proteins and cells produced by the fibroblast growth that results from a wound.

One of three types of white blood cells. Granulocytes digest bacteria and other parasites.

A natural hormone that stimulates white blood cell production, particularly that of granulocytes and monocytes (the precursors of macrophages).

(IEEE) A diagram or other representation consisting of a finite set of nodes and internode connections called edges or arcs.

Documents such as charts, diagrams, graphs which depict program structure, states of data, control, transaction flow, HIPO, and cause-effect relationships; and tables including truth, decision, event, state-transition, module interface, exception conditions/responses necessary to establish design integrity.

Generally Recognized as Safe (FDA)

A finished space in which clean utilities are generally located. This area has better finishes on the walls, ceilings, and floors than a conventional plant utility space but does not have finishes suitable to be rated as a classified space. This term is falling out of use in the biopharmaceutical industry.