Glossary Terms (Simple List)
-
Alert Limit
An established internal (in-house) data-based value giving early warning of potential drift of manufacturing process from normal operating conditions and triggers appropriate follow-up investigations. Alert limits are always lower than action limits. (TR69)
-
Alternative or Rapid Microbiological Method (RMM)
A novel, modern and/or fast microbiological testing method that is different from a classical or traditional growth-based method, such as agar-plate counting or recovery in liquid broth media. The alternative or rapid method may utilize instrumentation and software to manage the testing and resulting data, and may provide quantitative, qualitative and/or microbial identification test results. Automated technologies that utilize classical growth-based methods may also be designated as being novel, modern or rapid, based on their scientific principle and approach to microbial detection. The terms alternative, rapid microbiological method, rapid method and the acronym RMM are used interchangeably within this technical report. (TR33)
-
Ambient Temperature
The air temperature of an environment. (TR58)
-
Amplicon
A segment of double stranded DNA formed as the product of polymerase chain reaction or other amplification based techniques such as TMA or NASBA. (TR50)
-
Anaerobe
An organism that has the ability to grow in the absence of oxygen. (TR51)
-
Anaerobic Microorganism
A microorganism that does not utilize oxygen as the final electron acceptor during metabolism; microorganism that will grow only in the absence of oxygen. (TR62)(TR22)
-
Analysis of Variance (ANOVA)
A general statistical approach to data analysis (i.e., comparison of means) in which the variation in a method’s results is partitioned among explanatory factors in order to systematically assess factor influence and/or variance components. (TR57)
-
Analyte
Substance (usually a residue) for which an analysis is being performed. (TR29) (TR49) (TR70)
A specific chemical moiety being measured, which can be intact drug, biomolecule or its derivative, impurity, and/or excipients in a drug product. [Synonym: measurand] (TR57)
-
Analytical Control
Material used to monitor the performance of a method to assess the integrity and validity of the results. (TR57-2)
-
Analytical Instrument Qualification (AIQ)
The qualification of the analytical instrument(s) used as part of the analytical procedure. (TR57)