Glossary

Multi-Dimensional Screening and Analysis

Medical Device User Free and Modernization Act

Multiple Effect (still)

In statistics, the arithmetic average; the sum of all measurements or values in a sample divided by the sample size.

(ICH Q1A (R2)) A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation. When establishing the mean kinetic temperature for a defined period, the formula of J. D. Haynes (J. Pharm. Sci., 60:927-929, 1971) can be used.

Mean Kinetic Temperature (MKT) is defined as the single calculated temperature at which the total amount of degradation over a particular period is equal to the sum of the individual degradations that would occur at various temperatures.

Single calculated temperature at which the degradation of an article would be equivalent to the actual degradation that results from actual temperature fluctuations during the storage period. It is not a simple arithmetical mean. The MKT is calculated from average storage temperatures recorded over a one-year period, with a minimum of 12 equally spaced storage temperatures being recorded.

A measure of the reliability of a computer system, equal to average operating time of equipment between failures, as calculated on a statistical basis from the known failure rates of various components of the system.

A measure of reliability, giving the average time before the first failure.

A measure of reliability of a piece of repairable equipment, giving the average time between repairs.

Of or pertaining to a weld bead that deviates from side to side across the weld joint rather than tracking the joint precisely.

Capable of being measured.

(ISO/IEC: 99:2007) Quantity intended to be measured.

(IEEE) A quantitative assessment of the degree to which a software product or process possesses a given attribute.

The process of determining the value of some quantity in terms of a standard unit.

(ISO/IEC: 99:2007) Closeness of agreement between a measured quantity value and a true quantity value of a measurand.

(ISO/IEC: 99:2007) Closeness of agreement between indications or measured quantity values obtained by replicate measurements on the same or similar objects under specified conditions.

Measurement Precision under a set of conditions that includes the same : measurement procedure, operators, measuring systems, and locations.

Measurement Precision under a set of conditions that includes different measurement procedures, operators, measuring systems, and locations.

(ISO/IEC: 99:2007) Non-negative parameter caracterizing the dispersion of the quantity values being attributed to a measurand, based on the information used. Note: This is not inconsistent with the more commonly quoted definition given in the first edition of the VIM, i.e., an estimate characterizing the range of values within which the true value of the measure and lies”.

Data analysis which provides information to establish the extent of confidence limits bounding a measurable quantity.

(ISO/IEC: 99:2007) Device used for making measurements, alone or in conjunction with one or more supplementary devices.

Cross-sectional area for testing or measuring a performance parameter such as the airflow velocity.

The point in a project at which all equipment and materials have been installed but not commissioned (started-up).