Glossary

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.

(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.

To prove to be true by demonstration.

To check the results of data entry; e.g., keypunching.

(ANSI) To determine whether a transcription of data or other operation has been accomplished accurately.

An established cell line derived from the kidney of the African green monkey.

Victorian Electronic Records Strategy (Australia)

An initial release or a complete re-release of a software item or software element.

A unique identifier used to identify software items and the related software documentation which are subject to configuration control.

A classification of ICs [chips] based on their size as expressed by the number of circuits or logic gates they contain. A VLSI IC contains 100,000 to 1,000,000 transistors.

A temperature control method consisting of a double wall outside the main vessel wall. Liquid or steam flows through the jacket to heat (or cool) the fluid in the vessel. Because biopharmaceutical products are so sensitive and vessel jackets can cause uneven heating (hot or cold spots), shell-and-tube or plate-and-frame heat exchangers are more common in biopharmaceutical production systems.

Referring to pharmaceuticals or biologicals intended for animal use. Historically veterinary products were made by less than “Good Manufacturing Products”. Today, however, the GMPs refer to both human and veterinary products.

Variable Frequency Drive

Vaporized Hydrogen Peroxide

Video Home System

Life and health, ability to grow and reproduce; a measure of the proportion of live cells in a population.

Assay of the number or percent of living cells or plants in a population that have been given a specific treatment; such as ascertaining cell viability after cryopreservation treatment, or for seeds.

Living.

As it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary of Health and Human Services may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.

Capable of living and reproducing. Thus, nothing is sterile as long as it contains even a single viable organism.