Glossary Terms (Simple List)
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Method Parameter
Any factor or method operational step that can be varied continuously (e.g., flow rate) or specified at controllable unique levels (e.g., Gas Chromatograph liner type).
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Method Qualification
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 and is documented to be suitable for its intended use. (TR56)
Experimental studies performed to confirm the inherent performance capabilities of a test method for the material being analyzed and the intended use of the method. Method qualification can be performed during early development phases, prior to method validation. Specific method qualification characteristics (e.g., accuracy, specificity) should be confirmed based on the intended use of the analytical method and the relevant risk(s). (TR57)
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Method Validation
A formal, archived demonstration of the analytical capacity of an assay that provides justification for use of the assay for an intended purpose. (TR56)
A formal, archived demonstration of the analytical capacity of an assay that provides justification for use of the assay for an intended purpose. Validations are conducted prospectively according to a written, approved plan that states acceptance criteria. (TR57) (TR57-2)
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Method, Qualitative
An analytical procedure, based on the characteristics of a material that yields results that are not amenable to reliable enumeration. (TR57)
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Method, Quantitative
An analytical procedure that yields numerical results compared to quantitative specification(s). (TR57)
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Microbial By-Products
An analytical procedure that yields numerical results compared to quantitative specification(s). (TR57)
Organic compounds produced by microorganisms during metabolism and released into the bulk-phase environment. (TR69)
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Microbial Characterization
The description of microorganisms based on their cellular morphology, Gram reaction, and key diagnostic tests (e.g., Gram-positive coagulase-negative cocci). (TR13)
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Microbial Classification
The arrangement of microorganisms into taxonomic groups based on their similarities and relationships. (TR13)
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Microbial Count Determination
A test performed to quantify the number of microorganisms present in a sample of material. Standard microbial methods are utilized to estimate the number of colony forming units (CFU) per unit mass or volume. (TR28)
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Microbial Data Deviation
A microbial test result that deviates from approved specifications or in-process limits. (TR88)