DATA QUALITY

Question 1

defined as a deviation from the
absolute value or from the true
average of a large number of results.

Answer 1

Error

Question 2

can be classified as systematic
error or indeterminate error

Answer 2

Error

Question 3

Systematic Errors
- also known as the

Answer 3

determinate errors.

Question 4

errors that are reproducible and can be
discovered and corrected.

Answer 4

Systematic Errors

Question 5

Systematic Errors Can be further classified into:

Answer 5

Instrumental Error
- Method Error
- Personal Error

Question 6

failure to calibrate, degradation of
parts in the instrument, power fluctuations, variation in
temperature.

Answer 6

Instrumental Error

Question 7

rrors due to no ideal physical or
chemical behaviour, completeness and speed of
reaction,
interfering side reactions, sampling problems.

Answer 7

method Errors

Question 8

occur where measurements require
judgment, result from prejudice, color acuity problems,
negligence to follow proper procedures

Answer 8

Personal errors

Question 9

are observed by the same
analyst when the successive measurements are
made with the same identical conditions.

Answer 9

Random Errors

Question 10

Random Errors also known as the

Answer 10

indeterminate errors .

Question 11

appear as slight variations in successive
measurements due to causes that the analyst
can not control.

Answer 11

Random Errors

Question 12

A plot of indeterminate error would show a

Answer 12

normal frequency curve

Question 13

Minimization of Errors

Answer 13

Proper calibration of the glass ware, pipettes,
burettes, weights, balances, instruments, etc.
* By running the blank with the sample. The blank
solution is defined as the solution by omitting
the sample addition. The blank and the sample
solutions are carried simultaneously to obtain
the accurate results.
* By running the parallel determinations.
* Correctly recording and computing data results

Question 14

is establishing documented
evidence which provides a high degree of
assurance that a specific process, method, system,
activity or equipment consistently produce a
product meeting its predetermined specifications

Answer 14

Validation

Question 15

pertains to agreement of an
experimental results with true value

Answer 15

Accuracy

Question 16

is the measure of reproducibility of
data within a series of results.

Answer 16

Precision

Question 17

In a normal distribution,
__% of the values should
fall within one standard
deviation in either side of
the mean

Answer 17

68%

Question 18

In a normal distribution,
68% of the values should
fall within ____ standard
deviation in either side of
the mean

Answer 18

ONE

Question 19

And __% should fall within
two standard deviations of
the mean

Answer 19

95

Question 20

And 95% should fall within
___ standard deviations of
the mean

Answer 20

2

Question 21

So, standard deviation
should be a ____
percentage of the mean.

Answer 21

SMALL

Question 22

measure of central tendency

Answer 22

Mean

Question 23

difference between largest/smallest
observations in a set of data

Answer 23

Range

Question 24

measures the difference of the
actual values with the mean value

Answer 24

Average Deviation

Question 25

determined by dividing the average deviation by the mean

Answer 25

Relative average deviation

Question 26

sum of squares difference of the actual values with the mean value/total number of samples

Answer 26

Variance

Question 27

Square root of variance

Answer 27

Standard Deviation

Question 28

Is used to measure precision of a data set.

Answer 28

Relative Standard Deviation (%RSD)

Question 29

is a measure of the accuracy of the method.

Answer 29

Percentage Relative Error (E)

Question 30

is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications.

Answer 30

Validation

Question 31

provides an assurance of reliability during normal use, and is sometime referred to as “the process for providing documented evidence that the method does what it is intended to do.

Answer 31

validation

Question 32

Purpose of Validation

Answer 32

For identification of sources and quantitation of potential error * To determine if method is acceptable for intended use. * To satisfy FDA requirements * To ensure the consistency of the output

Question 33

TYPES OF ANALYTICAL PROCEDURES TO BE VALIDATED

Answer 33

1. Identification tests 2. Quantitative tests for impurities content. 3. Limit tests for the control of impurities . 4. Quantitative tests of the active moiety in samples of drug substance.

Question 34

VALIDATION PARAMETERS

Answer 34

* Accuracy * Precision * Range * Specificity * Linearity * Ruggedness

Question 35

is the closeness of test results obtained by that procedure to the true value.

Answer 35

ACCURACY

Question 36

Determined by application of the analytical procedure to an analyte of known purity

Answer 36

ACCURACY

Question 37

Accuracy should be assessed using a minimum of ____ determinations over a minimum of three concentration levels, covering the specified range.

Answer 37

9

Question 38

Accuracy should be assessed using a minimum of nine determinations over a minimum of ____ concentration levels, covering the specified range.

Answer 38

3

Question 39

It is the degree of agreement among individual test results when the procedure is applied repeatedly to multiple samplings of a homogeneous sample.

Answer 39

PRECISION

Question 40

Precision may be a measure of either the degree of ______ OR _____ of the analytical procedure under normal operating conditions .

Answer 40

reproducibility or of repeatability

Question 41

3 Levels of Precision

Answer 41

1, Repeatability 2. Intermediate Precision 3. Reproducibility

Question 42

expresses the precision under the same operating conditions over a short interval of time.

Answer 42

Repeatability

Question 43

Repeatability is also termed

Answer 43

intra-assay precision.

Question 44

expresses variations within laboratories, such as different days, different analysts, different equipment, and so forth. - to verify that in the same laboratory the method will provide the same results once the development phase is over.

Answer 44

Intermediate precision

Question 45

expresses the precision between laboratories. The objective of reproducibility is to verify that the method will provide the same results in different laboratories

Answer 45

Reproducibility

Question 46

the ability to measure accurately and specifically the analyte of interest in the presence of other components that may be expected to be present in the sample matrix

Answer 46

SPECIFICITY

Question 47

In case of identification tests, the method should be able to discriminate between compounds of closely related structures which are likely to be present.

Answer 47

SPECIFICITY

Question 48

It is the lowest amount of analyte in a sample that can be detected, but not necessarily quantitated, under the stated experimental conditions.

Answer 48

DETECTION LIMIT

Question 49

Its usually expressed as the concentration of analyte (e.g., percentage, parts per billion) in the sample

Answer 49

DETECTION LIMIT

Question 50

The detection limit is a characteristic of

Answer 50

limit tests

Question 51

It is the lowest amount of analyte in a sample that can be determined with acceptable precision and accuracy under the stated experimental conditions

Answer 51

QUANTITATION LIMIT

Question 52

is a characteristic of quantitative assays for low levels of compounds in sample matrices, such as impurities in bulk drug substances and degradation products in finished pharmaceuticals

Answer 52

QUANTITATION LIMIT

Question 53

Its 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

Answer 53

LINEARITY

Question 54

refers to the linearity of the relationship of concentration and assay measurement.

Answer 54

LINEARITY

Question 55

it is the interval from the upper to the 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

Answer 55

RANGE

Question 56

It’s the measure of its capacity to remain unaffected by small but deliberate variations in procedural parameters listed in the procedure documentation and provides an indication of its suitability during normal usage

Answer 56

ROBUSTNESS

Question 57

Refers to the degree of reproducibility of test results under a variety of conditions such as q Different laboratories q Different Analysts q Different Instruments q Different Days

Answer 57

RUGGEDNESS

Question 58

Analytical methods for quantitation of major components of bulk drug substances

Answer 58

Category I:

Question 59

Analytical methods for determination of impurities in bulk drug substances

Answer 59

Category II:

Question 60

Analytical methods for determination of performance characteristics

Answer 60

Category III:

Question 61

Identification tests.

Answer 61

Category IV: