Glossary Terms (Simple List)

Term used to describe the state or appearance of the product during 100% or AQL visual in­spection (prior to labeling). As marketed refers to the product in-situ or the form in which it is distributed, for example clear liquid, lyophilized, powder, opalescent liquid, etc. (TR79)

Studies designed to increase the rate of chemical degradation or physical change of a drug substance or drug product by using exaggerated storage conditions as part of the formal stability studies. (TR57-2)

A dose that is unlikely to cause an adverse effect if an individual is exposed, by any route, at or below this dose every day for a lifetime. (TR29)

An amount of a substance consumed on a daily basis that is considered at a safe level. (TR29)

An amount of a substance administered or consumed on a daily basis that is considered a safe level. (TR49)

The quality level that is the worst-tolerable process average when a continuing series of lots are submitted for acceptance sampling. (TR43) (TR 76)

The extent to which, or the limits between which, acceptable variation exists.(TR38)

Numerical limits, ranges, or other suitable measures for acceptance of test results. (TR 14) (TR 29) (TR 38) (TR 64)

Numerical limits, ranges, or other suitable measures for acceptance of test results. Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation. Exceeding the operating range should be documented and explained in the validation report and evaluated for validation study impact. (TR 42)

The pre-defined specifications, standards or ranges that must be met under stated test conditions. (TR 48)

Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical method validation that is satisfied to determine suitability of test method performance.(TR 57) (TR 69) (TR 72) (TR 74)

The criteria that a system or component must satisfy in order to be accepted by a user or other authorized entity. (TR 54-5)

Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures which the drug substance or drug product or materials at other stages of their manufacture should meet (16). Exceeding the acceptable range for a critical parameter during subsequent validation studies may result in questionable product quality that would require initiation of an investigation and possible batch rejection. (TR60)

The maximum amount of residue allowed in a product, in an analytical sample, or as an amount per surface area. (TR29)

The closeness of the actual test results obtained by the new method to the actual test results obtained by the existing method. (TR33)

An analytical procedure expresses the closeness of agreement between the value that is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness. (TR57)

A. laidlawii is a mycoplasma in class Mollicutes and order Acholeplasmatales. (TR75)