Glossary

The process of managing media upon which information is stored.

(ICH Q1A (R2)) The acceptable variations in temperature and relative humidity of storage facilities for formal stability studies. The equipment should be capable of controlling the storage condition within the ranges defined in this guideline. The actual temperature and humidity (when controlled) should be monitored during stability storage. Short term spikes due to opening of doors of the storage facility are accepted as unavoidable. The effect of excursions due to equipment failure should be addressed, and reported if judged to affect stability results. Excursions that exceed the defined tolerances for more than 24 hours should be described in the study report and their effect assessed.

A unit into which data or programs can be placed, retained and retrieved.

This is a determination of whether or not certain processing conditions use more storage (memory) than estimated.

Shielded Twisted Pair

A population of cells all descended from a single cell.

Tactical relationships between an owner and its suppliers, service providers, or equipment manufacturers which benefit both parties by an agreement based on volume and price.

A path in a steady flow field along which a given fluid particle travels.

The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or the potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard).

Stress

(IEEE) Testing conducted to evaluate a system or component at or beyond the limits of its specified requirements. Synonymous: Boundary Value Testing.

(ICH Q1A (R2)) Studies undertaken to assess the effect of severe conditions on the drug product. Such studies include photostability testing (see ICH Q1B) and specific testing on certain products, (e.g., metered dose inhalers, creams, emulsions, refrigerated aqueous liquid products).

(ICH Q1A (R2)) Studies undertaken to elucidate the intrinsic stability of the drug substance. Such testing is part of the development strategy and is normally carried out under more severe conditions than those used for accelerated testing.

A type of corrosion that occurs due to sudden failure of normally ductile metals subjected to a constant tensile stress in a corrosive environment, particularly at elevated temperatures. This type of corrosion progresses rapidly. Certain austenitic stainless steels alloys crack in the presence of chlorides, which limit their usefulness for being in contact with solutions (including water) with higher, that a few ppm content of chlorides at temperature above 50°C. This form of corrosion is only applicable to the austenitic group of steels and is related to the nickel content; Ferritic grades do not generally suffer from this problem at all.

Failure by cracking under the combined action of corrosion and stress, either external (applied) or internal (residual). Cracking may be either intergranular or transgranular, depending on the metal and the corrosive medium.

A linear sequence of entities such as characters or physical elements.

(IEEE) A sequence of characters.

Reaction conditions – notably temperature, salt concentration(s) and pH – that dictate the annealing of singlestranded DNA/DNA, DNA/RNA and RNA/RNA hybrids. At high stringency, duplexes form only between strands with perfect one-to-one complementarity; lower stringency allows annealing between strands with some degree of mismatch between bases.

(ICH Q3C (R4)) A substance for which there is no epidemiological evidence of carcinogenesis but there are positive genotoxicity data and clear evidence of carcinogenesis in rodents.

A DNA sequence that forms the blueprint for the synthesis of a polypeptide.

The effort to determine the 3D structures of large numbers of proteins using both experimental techniques and computer simulation.

(Bluhm, Meyers, Hetzel) Examining the internal structure of the source code. Includes low-level and high-level code review, path analysis, auditing of programming procedures, and standards actually used, inspection for extraneous “dead code”, boundary analysis and other techniques. Requires specific computer science and programming expertise.

(IEEE) A diagram that identifies modules, activities, or other entities in a system or computer program and shows how larger or more general entities break down into smaller, more specific entries. Note: The result is not necessarily the same as that shown in a call graph. Synonymous: Hierarchy Chart, Program Structure Chart.

(IEEE) Any disciplined approach to software design that adheres to specified rules based on principles such as modularity, top-down design, and stepwise refinement of data, system structure, and processing steps.

A design review conducted by identification of the characteristics of a good design to ensure that all relevant and appropriate aspects are examined.