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level: Validation

Questions and Answers List

level questions: Validation

Question	Answer
the process used to confirm that the analytical procedure employed for a specific test is fit for its intended application.	Validation
the action of proving that equipment works correctly and leads to expected results (DQ/IQ/OQ/PQ)	Qualification
The operations which establish, under specified conditions, the relationship between values indicated by a measuring system and the corresponding values of the known measurand	Calibration
– Identification tests. – Quantitative tests for impurities' content. – Limit tests for the control of impurities. – Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in the drug product.	4 most common types of analytical procedures
- Design Qualification (DQ) - Installation Qualification (IQ) - Operational Qualification (OQ) - Performance Qualification (PQ)	4 sections of equipment qualification
- The documented evidence that the proposed design of the system/equipment is suitable for the intended purpose. - Performed by instrument supplier	Design Qualification (DQ)
- documented verification that the instrument has been installed in the selected user environment. - Performed by instrument supplier	Installation Qualification (IQ)
- documented verification that the instrument, as installed in the selected user environment, performs according to its previously defined functional and performance specifications - performed by instrument supplier	Operational Qualification (OQ)
- documented verification that the instrument can perform effectively and reproducibly according to its specification appropriate to its routine use. - performed by the user	Performance Qualification (PQ)
.	Qualification Timeline
- when it is necessary to verify that its performance parameters are adequate for use for a particular analytical problem. eg, - new method developed for a particular problem	When must a method be validated?
the lab using the method	Who is responsible for ensuring method adequately validated?
Specificity Accuracy Precision Limit of detection Limit of quantitation Linearity Range Ruggedness and robustness	Validation Characteristics
- the way of performing the analysis - describe the steps to perform each analytical test (sample, reference standard, use of apparatus, generation of calibration curve)	Analytical Procedure
- The ability to assess, for certain, the analyte in the presence of components which may be expected to be present. - Typically these might include impurities, degradants, matrix, etc.	Specificity
expresses the closeness of agreement between a value which is accepted and the value found	Accuarcy
- The quality of being reproducible	Precision
1 - Repeatability 2 - Intermediate precision 3 - Reproducibility	3 levels of Precision
The lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.	Detection Limit
lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy	Quantitation Limit
ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample	Linearity
a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage	Robustness