Glossary

Vasopermeation Enhancement Agents

A new generation of drugs that increase the uptake of therapeutic agents to solid tumors.

An agent, such as an insect, that can carry a disease-producing organism from one host to another; the agent used to carry new genes into cells. Plasmids currently are the vectors of choice, though viruses and other bacteria may sometimes be used. These molecules become part of the cell protoplasm.

In bacteria, a stage of active growth, as opposed to a resting state or spore formation.

Vascular Endothelial Growth Factor

The host organism used for the replication or expression of a cloned gene or other sequence. The term is little used and is often confused with vector.

Any solvent or carrier fluid in a pharmaceutical product that has no pharmacological role. For example, water is the vehicle for xilocaine and propylene glycol is the vehicle for many antibiotics.

A person or an organization that provides software and/or hardware and/or firmware and/or documentation to the user for a fee or in exchange for services. Such a firm could be a medical device manufacturer.

An evaluation of the supplier’s ability to deliver a quality product/service.

Engineering Control used to reduce dust emissions by providing apartially closed process zone for the dust emitting process. Dust emissions from the partially closed process zone are controlled by providing an inflow of air through any openings to entrain and capture the dust on a filter typically located before the air vacuum/movement source.

The number of times in an hour that the air volume of a room is replaced.

Can be proved or confirmed by examination or investigation.

Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Verification is confirmation for a particular use whereas Validation is confirmation for a more general and intended use.

The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements. (also see: IQ (Installation Qualification))

(ISO) Confirmation, through the provision of objective evidence that specified requirements have been fulfilled.

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.NOTE: Monitoring and auditing methods, procedures and tests, including random sampling and analysis, can be used in the verification of the formal system.

(ISO) (ASTM E 2500) A systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses all types of approaches to assuring systems are fit for use such as qualification, commissioning and qualification, verification, system validation, or other.

Defined as “The process of evaluating the products of agiven phase to ensure correctness and consistency with respect to products and standards provided as input to that phase”.

(ASTM E2537-08) Guide for Application of Continuous Quality Verification to Pharmaceutical and Biopharmaceutical Manufacturing. Purpose is to address the application of continuous quality verification to those manufacturing processes that employ modern Quality Management Systems often supplemented with modern process analytical chemistry systems and controls.

(NBS) In general the demonstration of consistency, completeness, and correctness of the software at each stage and between each stage of the development lifecycle.