Glossary

(NIST) Testing of a module for typographic, syntactic, and logical errors, for correct implementation of its design, and for satisfaction of its requirements.

(IEEE) Testing of individual hardware or software units or groups of related units.

Cells that, after introduction into a recipient, will not induce an immune response that leads to their rejection.

Precautions taken when handling, storing, transporting, or shipping items or specimens containing, or contaminated with human blood and body fluids: all such materials are treated as infectious.

(ICH Q6A) A test which is considered to be potentially applicable to all new drug substances, or all new drug products; e.g., appearance, identification, assay, and impurity tests.

A healthcare institution that is part of a university that teaches medical students and conducts basic research (preclinical research) and clinical trials. Also called an academic medical center.

A multitasking, multiple-user (time-sharing) operating system developed at Bell Labs to create a favorable environment for programming research and development.

Maintenance that is performed without prior planning based on an immediate need either because a piece of equipment has failed or failure is imminent.

(ICH Q5A (R1)) One or multiple pooled harvests of cells and culture media. When cells are not readily accessible, the unprocessed bulk would constitute fluid harvested from the fermenter.

Unified Numbering System (Metalurgy)

A fatty acid containing one or more double bonds.

(ICH Q3B (R2)) A degradation product that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug product specification.

(ICH Q3A (R2)) An impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug substance specification.

A material other than an explosive, which in the pure state or as commercially produced will vigorously polymerize, decompose, condense or become self-reactive and undergo other violent chemical changes, including explosion, when exposed to heat, friction or shock, or in the absence of an inhibitor or in the presence of contaminants or in contact with noncompatible materials. Unstable, reactive materials are subdivided as follows:1.Class 4 – Materials that in themselves are readily capable of detonation or of explosive decomposition or explosive reaction at normal temperatures and pressures. This class includes materials that are sensitive to mechanical or localized thermal shock at normal temperatures and pressures.2.Class 3 – Materials that in themselves, are capable of detonation or of explosive decomposition or explosive reaction but which require a strong initiating source or which must be heated under confinement before initiation. This class includes materials that are sensitive to thermal or mechanical shock at elevated temperatures and pressures.3.Class 2 – Materials that in themselves are normally unstable and readily undergo violent chemical change but do not detonate. This class includes materials which can undergo chemical change with rapid release of energy at normal temperatures and pressures and which can undergo violent chemical change at elevated temperatures and pressures.4.Class 1 – Materials that in themselves are normally stable but which can become unstable at elevated temperatures and pressures.

Unsaturated Polyester

Uninterruptible Power Supply

1. In molecular biology, the stretch of DNA base pairs that lie in the 5’ direction from the site of initiation of transcription. Usually the first transcribed base is designated +1 and the upstream nucleotides are marked with minus signs, e.g., -1, -10. Also, to the 5’ side of a particular gene or sequence of nucleotides.2. In chemical engineering, those phases of a manufacturing process that precede the biotransformation step. Refers to the preparation of raw materials for a fermentation process. Also called upstream processing.

Ultrapure Water

Refers to software that runs not only on the computer for which it was designed, but also on newer and more powerful models. In the context of CFR 21 Part 11, compatibility plays an important role in ensuring that legacy data can be moved (copied) accurately and completely to a new system. Without it, legacy systems would have to be maintained as long as the records contained in them are kept.

User Requirement

A pyrimidine base important as a component of ribonucleic acid (RNA). Uracil is capable of forming a base pair with adenine.

User Requirement Brief

University Relations Committee (ISPE term)

Uniform Resource Identifier