Chemistry Reference
In-Depth Information
Glossary of Terms Related
to Chromatographic
Method Validation
Acceptance Criteria:
Numerical limits, ranges, or other criteria to which test results
for a drug substance, product, or other sample should conform to be consid-
ered acceptable for its intended use.
Accuracy:
The closeness of test results to the true value.
Active Pharmaceutical Ingredient (API or Drug Substance):
Any substance or
mixture of substances intended to be used in the manufacture of a drug
(medicinal) product that, when used in the production of a drug, becomes
an active ingredient of the drug product.
Analytical Instrument Qualification (AIQ):
The process of ensuring that an
instrument
is suitable for its intended application. AIQ is just one compo-
nent of data quality, which also includes software and analytical method
validation, system suitability tests, and quality control tests.
Analytical Performance Characteristics:
Parameters assessed during method
validation, including accuracy, precision, linearity (range), limit of quanti-
tation or detection, and robustness. Actual parameters assessed depend on
the type of method and its intended use.
Analysis of Variance (ANOVA):
A statistical test that measures the difference
between the means of groups of data. Sometimes called an F-test, ANOVA
is closely related to the t-test. The major difference is that where the t-test
measures the difference between the means of two groups, an ANOVA tests
the difference between the means of two or more groups.
Assay (Content or Potency):
An exact result that allows an accurate assessment of
the content or potency of the analyte in a formulation.
Assignable Cause:
The laboratory investigation following an out-of-specification
(OOS) result that determines the suspect result is due to a known cause such
as operator or instrument error.
Asymmetry:
Factor that describes the shape of a chromatographic peak. Theory
describes Gaussian symmetrical peak shapes. Peak asymmetry is measured
as the ratio of the distance between the peak apex and the back side of the
peak to the distance between the front side of the peak. A value >1 is a tail-
ing peak, while a value <1 is a fronting peak.
Audit:
A documented independent review performed on a periodic basis to verify
compliance with a quality system.
Batch:
A quantity of material produced during one manufacturing cycle using the
same specification.
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