Glossary

Volume of Rinse

On a volume per volume basis; the percent of the volume of a constituent in 100 units of volume, e.g., (ml/100 ml) x 100.

Verification and Validation

Volts, Alternating Current

A preparation of microbial antigens that provokes an immune response (i.e. the production of antibodies) on injection, thus conferring immunity on the recipient. There are three types of vaccines:1.Those containing material from a nonvirulent organism that retains its immunogenicity but does not result in infection.2.Those containing a modified toxin (a toxoid) that has lost its toxic properties but retains its immunogenicity.3.Those containing live, attenuated organisms (i.e. genetic variants of a virus or bacterium) that are antigenically similar to the original strain but lack virulence.Recombinant DNA research has allowed the production of new and more specific vaccines. For example, the gene for the B antigen of hepatitis virus has been cloned in E. coli, the protein expressed and a specific anti-B antiserum produced which can be used as a vaccine.

Antigens prepared from modified organisms that elicit immune response (antibody production) to protect a person or animal from a disease agent.

A preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms that is administered to produce or artificially increase immunity to a particular disease.

A biologic product generally made from an infectious agent or its components — a virus, bacterium, or other microorganism — that is killed (inactive) or live-attenuated (active, although weakened). Vaccines may also be biochemically synthesized or made through recombinant DNA techniques.

In cell and tissue culture, excess fluid, debris (aggregates), or gas (from sparging) can form inside a cell vacuole.

A cavity within the cell that can be relatively clear and fluid filled, gas filled (as in a number of blue-green algae), or food filled (as in protozoa).

Membrane-bound organelles of low density responsible for food digestion, osmotic regulation, and waste product storage. Vacuoles may occupy a large fraction of cell volume (up to 90% in plant cells).

Membrane-bound organelles of low density responsible for food digestion, osmotic regulation, and waste product storage. Vacuoles may occupy a large fraction of cell volume (up to 90% in plant cells).

The process of removing dissolved and entrained gases from the Reverse Osmosis (RO) product water by creating a vacuum in a tower through which this water flows. The degasifier may be located before the RO system but the majority of the time will be located after. The most prevalent gas present is Carbon Dioxide (CO2), which may have been generated during pH adjustment of the RO feed water. The anion exchange resin can remove CO2 but using the vacuum degasifier can reduce that load. The other gas of concern is oxygen, which can also be removed by a vacuum degasifier.

Voluntary Action Indicated (FDA)

One of over 20 naturally occurring amino acids.

Sound.

Well grounded on principles of evidence.

Able to withstand criticism or objection.

A testing technique using valid (normal or expected) input values or conditions.

(NBS) Test data that lie within the domain of the function represented by the program.

To prove to be valid.

(ICH Q7) A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.

Defined generically, a process to determine that a system or process is fit for the intended use. In ASTM 2500-07 and GAMP 5, verification in concert with design review activities fulfill this objective.

For the purposes of this Guide (ISPE GPG Assessing the Particulate Containment Performance of Pharmaceutical Equipment) the term “validation” is used only in relation to quantitative, analytical methods and is not meant to denote a cGMP-related context

The action of proving, in accordance with the principles of GxP, that any procedure, process, equipment material, activity or system actually leads to the expected results.