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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
Types of Analytical Procedures to be Validated	1 Identification tests 2 Testing for impurities 3 Assay procedures
are intended to ensure the IDENTITY of an analyte in a sample	Identification tests
can be either a quantitative test or a limit test for the impurity in a sample	Testing for impurities
are intended to MEASURE the analyte present in a given sample	Assay procedures
Typical Validation Characteristics	1 Accuracy 2 Precision - Repeatability - Intermediate Precision 3 Specificity 4 Detection Limit 5 Quantitation Limit 6 Linearity 7 Range
Revalidation may be necessary in the following circumstances:	- changes in the SYNTHESIS of the drug substance; - changes in the COMPOSITION of the finished product; - changes in the ANALYTICAL procedure.
refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test.	Analytical Procedure
the ability to assess unequivocally the analyte in the presence of components which may be expected to be present. This definition has the following implications: - Identification - Purity Tests - Assay (content or potency)	Specificity
expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. Sometimes called "TRUENESS"	ACCURACY
expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions.	PRECISION
Three Levels of Precision	1 Repeatability 2 Intermediate precision 3 Reproducibility
Expresses the precision under the same operating conditions over a short interval of time. It is also termed intra-assay precision	REPEATABILITY
expresses within-laboratories variations: different days, different analysts, different equipment, etc.	INTERMEDIATE PRECISION
expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology).	REPRODUCIBILITY
the lowest amount of analyte in a sample which can be detected but NOT NECESSARILY QUANTITATED as an exact value.	DETECTION LIMIT
the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. Determination of impurities and/or degradation products	QUANTITATION LIMIT
Obtain test results which are DIRECTLY PROPORTIONAL to the concentration (amount) of analyte in the sample.	LINEARITY
Interval between the upper and lower concentration (amounts) of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.	RANGE
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
Main Objective of validation of an analytical procedure:	To demonstrate that the procedure is suitable for its intended purpose.