Glossary Terms (Simple List)
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Analytical Method Comparability (AMC)
Equivalence study that measure the same property of two methods and that shows that replacing one of these methods with the other would not adversely affect the test’s use or results. (TR57-2)
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Analytical Method Design
Collection of activities performed to define the intended purpose of the method, select the appropriate technology to implement the method, and identify the critical method variables that need to be controlled to ensure that the method is robust and rugged. (TR57-2)
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Analytical Method Development (AMD)
Collection of activities performed to select an appropriate technique and method conditions to meet the Analytical Target Profile (ATP) requirements. (TR57-2)
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Analytical Method Qualification (AMQ)
Formal or informal study performed to assess initial method performance prior to full ICH Q2(R1) validation; assessment activity that culminates in a scientifically sound method that has an acceptable level of performance, is documented to be suitable for its intended use, and is demonstrated to have “adequate capability … to meet appropriate standards of performance for its purpose” (TR57-2)
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Analytical Method Transfer (AMT)
Documented process that qualifies a laboratory (receiving unit) to use an analytical test procedure that originates in another laboratory (the transferring unit, also known as the sending unit), thus ensuring that the receiving unit has the knowledge and ability to perform the transferred analytical procedure as intended. (TR57-2)
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Analytical Platform Technology (APT)
An analytical method that is used for multiple products and/or types of sample matrix without modification of the procedure. Similar to compendial methods, an APT method may not require full validation for each new product or sample type. (TR57)
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Analytical Procedure
That which is performed in order to obtain a reportable result. The procedure should describe in detail the steps necessary to perform the analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generations of the calibration curve, use of the formulae for the calculation [Synonym: Method, Assay] (TR57)
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Analytical Target Profile (ATP)
Set of predefined method parameters and performance requirements that help identify the type of method desired relative to method categories (identity, purity, and impurity) defined in ICH Q2(R1) as well as the necessary method performance attributes, such as accuracy, precision, and specificity. (TR57-2)
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Ancillary Packaging Components/Systems
Additional means used in combination with the basic transportation unit to maintain the required temperature during transport. Examples include active systems and passive systems. (TR39)
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Animal-Derived Raw Materials (Primary)
Contains in the final raw material or uses in the manufacturing process of the final raw material, any raw material derived directly from bovine or other animal tissues, for example, bovine serum, porcine-derived trypsin, and animal-tissue-derived hydrolysates. (TR83)