P Ana 2 Definitions Flashcards
a measure of how close a measurement is to the correct or accepted value of the quantity
being measured.
Accuracy
substance being analyzed by (for example) mass spectrometry, infrared spectroscopy, NMR spectroscopy, or chromatography.
Analyte
this consists of all the reagents or solvents used in an analysis without any of the analyte being present.
Analytical Blank
involves comparison of the value or values of a particular parameter measured by the system under strictly defined conditions with pre-set standard values.
Calibration
document with the results of all tests conducted on material to show compliance or non-compliance with the standard specifications.
Certificate of Analysis
this should cover all characteristics that affect the proper performance,
purity, safety, and stability of the product.
Finished product specification
this is concise and precise statement of the ingredients that comprise the product, together with the percentage and/or weight of each
Formula
expresses within-laboratory variation precision when the analysis is carried out by different analysis, on different days and with different equipment
Intermediate Precision
ability to elicit test results that are directly, or by a well-defined mathematical transformation,
proportional to the concentration of analyte in samples within a given range.
Linearity
(a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings and/or animals; or
Medical Product
Document that specifies all the tests to be conducted on a product and/or appropriate references containing details of procedure and expected result.
Monograph
a measure of how close a series of measurements are to one another
Precision
totality of characteristics or features of a product that bears its capacity to satisfy stated or implied needs.
Quality
sum total of the organized arrangements made with the object of ensuring that products will be consistently of the quality required by their intended use.
Quality Assurance
part of GMP concerned with sampling, specifications, testing, organization,
documentation, and release procedures.
Quality Control
this should enumerate the characteristics of all the materials that go into the product and the permissible range of purity of each ingredient.
Raw Material Specification
expresses the precision obtained under the same operating conditions over a short
interval of time. It can also be termed intra-assay precision.
Repeatability
expresses the precision among laboratories. Such a trial would be carried out when a method was being transferred from one part of a company to another.
Reproducibility
evaluated in order to determine how resistant the precision and accuracy of an assay are to small variations in the method.
Robustness
Finite number of objects selected from a batch.
Sample
a measure of how capable it is of measuring the analyte alone in the presence of other compounds contained in the sample
Selectivity
amount of radiant energy that has interacted with the chemical species. It is also the power of transmitted, fluorescent, reflected or emitted light .
Spectrometry
measurement of radiant energy absorbed or transmitted at a definite and narrow wavelength.
Spectrophotometry
is the study of the absorption and emission of light and other radiation by matter.
Spectroscopy
