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PHAN 1 LEC > TOPIC 3: Data Quality > Flashcards

TOPIC 3: Data Quality Flashcards

1
Q

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

A

Error

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2
Q

Error can be classified as?

A

systematic error and indeterminate error

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3
Q

Classes of Error

A

Systematic (Determinate Errors)
Random (Indeterminate Errors)

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4
Q

Errors that are reproducible and can be discovered and corrected.

A

Systematic Errors

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5
Q

Systematic Errors can be further classified into:

A

Instrumental Error
Method Error
Personal Error

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6
Q

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

A

Instrumental Errors

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7
Q

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

A

Method Errors

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8
Q

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

A

Personal Errors

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9
Q

This is observed by the same analyst when the successive measurements are made with the SAME IDENTICAL conditions.

A

Random Errors

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10
Q

Determinate Errors

A

Systematic Errors

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11
Q

Indeterminate Errors

A

Random Errors

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12
Q

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

A

Random Errors

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13
Q

A plot of indeterminate error would show a ________ frequency curve.

A

normal

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14
Q

This 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.

A

Validation

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15
Q

Pertains to agreement of an experimental results with true value.

A

Accuracy

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16
Q

The measure of reproducibility of data within a series of results

A

Precision

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17
Q

Measure of central tendency.

A

Mean

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18
Q

Difference between largest/smallest observations in a set of data.

A

Range

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19
Q

This measures the difference of the actual values with the mean value.

A

Average Deviation

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20
Q

Determined by dividing the average deviation by the mean.

A

Relative Average Deviation

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21
Q

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

A

Variance

22
Q

Square root of variance

A

Standard Deviation

23
Q

____________ of an analytical procedure 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.

A

Validation

24
Q

This 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.”

A

Method Validation

25
Q

Purpose of Validation

A

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

26
Q

TYPES OF ANALYTICAL PROCEDURES TO BE VALIDATED

A
  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.
27
Q

Validation Parameters

A

Accuracy

Precision

Range

Specificity

Linearity

Ruggedness

28
Q

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

A

Accuracy of an analytical procedure

29
Q

Determined by application of the analytical procedure to an analyte of known purity (e.g. A Reference Standard).

A

Accuracy

30
Q

Accuracy should be assessed using ___________________________, covering the specified range. (i.e. Three concentrations and three replicates of each concentration

A

a maximum of 9 determinations over a minimum of 3 concentration levels

31
Q

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

A

Precision

32
Q

Precision may be a measure of either the degree of ____________ or of ____________ of the analytical procedure under normal operating conditions.

A

reproducibility or repeatability

33
Q

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

A

Repeatability

34
Q

Repeatability is also termed ?

A

intra-assay precision

35
Q

Expresses variations within laboratories, such as different days, different analysts, different equipment, and so forth.

A

Intermediate precision

36
Q

In intermediate precision, to verify that in the same laboratory the method will provide the _____________ once the development phase is over.

A

same results

37
Q

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

A

Reproducibility

38
Q

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.

A

Specifity

39
Q

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

A

Specificity

40
Q

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

A

Detection Limit

41
Q

The detection limit is a characteristic of?

A

Limit tests

42
Q

Detection Limit is usually expressed as the ___________________ (e.g., percentage, parts per billion) in the sample.

A

concentration of analyte

43
Q

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

A

Quantitation Limit

44
Q

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.

A

Quantitation Limit

45
Q

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.

A

Linearity

46
Q

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

A

Linearity

47
Q

Requires a minimum of 5 concentration levels.

A

Linearity

48
Q

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.

A

Range

49
Q

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.

A

Robustness

50
Q

Refers to the degree of reproducibility of test results under a variety of conditions such as:

Different laboratories

Different Analysts

Different Instruments

Different Davs

A

Ruggedness

51
Q

Ruggedness refers to the degree of reproducibility of test results under a variety of conditions such as:

A

Different laboratories
Different Analysts
Different Instruments
Different Davs

52
Q

Data Elements Required for Validation

A

Category I: Analytical methods for quantitation of major components of bulk drug substances

Category II: Analytical methods for determination of impurities in bulk drug substances

Category III: Analytical methods for determination of performance characteristics

Category IV: Identification tests.

PHAN 1 LEC (14 decks)

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