Glossary Terms (Simple List)
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Equilibria Moisture Content of Wood
The moisture content of wood below the fiber saturation point is a function of both the relative humidity and the temperature of surrounding air. The equilibrium moisture content (EMC) is the moisture content at which the wood is neither gaining nor losing moisture; this however, is a dynamic equilibrium and changes with relative humidity and temperature. (TR55)
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Equipment
Automated or non-automated, mechanical or non-mechanical equipment used to produce the drug product, including equipment used to package the drug product. (TR38)
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Equipment Train
The sequence of equipment through which a product is produced or processed. (TR29) (TR49)
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Equivalence
See Comparability. (TR38)
A comparison with the primary objective of showing that the results from two methods differ by an amount which has negligible impact on fitness for use. This is usually demonstrated by showing that the true difference is likely to lie between a lower and an upper equivalence margin of acceptance differences. (TR57)
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Equivalence Margin
The largest difference between the results from two methods that is considered as being scientifically and statistically acceptable. (TR57)
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Equivalence Test
Test of conformance to interval-based target acceptance criteria; differs from most common statistical tests in the nature of the statistical hypothesis. In equivalence testing, the alternative hypothesis is that the difference is sufficiently small that no important difference exists. A common statistical procedure used for equivalence testing is the two one-sided T-test. (TR57-2)
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Equivalence/Comparative Testing
A measure of how similar the test results are when compared with the existing method. (TR33)
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Error
Deviation from expected value. Error may be random or systematic. (TR57)
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Error, Laboratory
A self-evident documented mistake that will bring the validity of a laboratory test into question. (TR88)
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Error, Manufacturing
A self-evident documented mistake that will bring the manufacturing process into question. (TR88)