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Quality Control (Part 1)

Total questions: 100

Worksheet time: 2hrs 40mins

Name
Class
Date
1.

Suppository that does not melt at body temperature is what kind of defect?

a)

Major

b)

Critical

c)

Minor

d)

Performance

2.

Samples of raw materials in the quarantine area will not be subjected to this test:

a)

Physical & organoleptic examination

b)

Leaker test

c)

Potency assay

d)

Microbiological test

3.

It is the sum of all factors which contribute directly or indirectly to the safety, effectiveness and acceptability of the product.

a)

Quality Assurance

b)

Quality

c)

Conformance

d)

Quality Control

4.

Which of the following are possible sources of variation?

a)

Men

b)

Materials

c)

Method

d)

AOTA

5.

An impairment of the condition or quality of drug:

a)

Adulteration

b)

Deterioration

c)

Counterfeit

d)

Misbranding

6.

Drug recall:

a)

A. Is a function of the regulatory agency

b)

B. Should be filed by a dissatisfied customer

c)

C. Damages the reputation of the company

d)

AOTA

7.

The sampling and examination of all raw materials received by the factory is a function of the:

a)

Documentation section

b)

Biological testing laboratory

c)

Material inspection methods

d)

Analytical laboratory

8.

Quality Assurance is concerned with:

a)

A. Quality monitoring and audit

b)

 B. Making sure quality policies are followed

c)

C. Stability testing

d)

A and B

9.

What physical test(s) can be used as an identity check for raw materials?

a)

A. Melting point

b)

B. Color

c)

C. Specific gravity

d)

D. A and C

10.

The following are duties of the quality control department, except:

a)

A. Establishment of written sampling plan

b)

B. Taking part in the validation program

c)

C. Audit

d)

D. Accreditation of raw material suppliers

11.

Exposure of bacterial plates in the production areas to determine the microbiological load of each room is called:

a)

A. Environmental monitoring

b)

B. Pollution monitoring

c)

C. Sterility testing

d)

D. Validation

12.

Visual appearance is essential for all, except:

a)

Aerosols

b)

Liquid preparation

c)

Tablets and Capsules

d)

 Lyophilized preparations

13.

The company’s removal or correction of a marketed product that the regulatory agency consider to be in violation of the laws and against which the agency would initiate legal action:

a)

Recall

b)

Market withdrawal

c)

Stock recovery

d)

NOTA

14.

In SQC, the control chart prepared based on the number of fraction defective is called:

a)

Attribute chart

b)

Beer’s plot

c)

Bar chart

d)

Variable chart

15.

A critical defect that would stop the packaging line operations:

a)

Wrong labels

b)

Misaligned labels

c)

Inverted labels

d)

Smeared labels

16.

The degree of freedom is used in the calculation of:

a)

Average

b)

Mean

c)

Range

d)

Standard deviation

17.

A common sampling plan using master tables to interpret results is:

a)

A. 100% Inspection

b)

B. Square root system

c)

C. Military standard

d)

D. A and C

18.

Quality can be monitored by the application of:

a)

Algebra

b)

Statistics

c)

Calculus

d)

Trigonometry

19.

A tool for detecting variations in a process is the:

a)

Pie Chart

b)

Bar Graph

c)

Quality Control Chart

d)

T-Chart

20.

The variation of the amount of defective present can be shown in a:

a)

 P-Chart

b)

X-Chart

c)

R-Chart

d)

T-Chart

21.

The process of removing an appropriate number of items from a population in order to make inferences to the entire population

a)

Sampling

b)

Inspection

c)

Control

d)

Statistic

22.

A process is in control if the value obtained is within _____ standard deviation.

a)

Two

b)

Three

c)

Four

d)

Five

23.

Sampling plan using the square root system:

a)

100% Inspection

b)

Random sampling

c)

Military standard

d)

None of the above

24.

Acceptable quality level is considered acceptable if it contains _____ defective tablets:

a)

2 %

b)

3 %

c)

4 %

d)

5 %

25.

Unacceptable quality level is considered unacceptable if it contains _____ defective tablets:

a)

2 %

b)

3 %

c)

4 %

d)

5 %

26.

The ratio between the number of defectiveness found to the total number of units inspected in a series of batches:

a)

Average mean

b)

Fraction defective

c)

Standard deviation

d)

Range

27.

Methods of sampling plan:

a)

100% Inspection

b)

Random sampling

c)

Military standard

d)

AOTA

28.

Military standard table is also known as:

a)

Government sampling plan

b)

MIL – STD – 105 D

c)

ABC – STD 105 D

d)

AOTA

29.

The average fill volume was 60mL within-in-process specification of 57-63 mL, if one standard deviation is 0.5mL, calculate UCL & LCL.

a)

58.5 – 61.5

b)

59 – 61

c)

59.5 – 60.5

d)

NOTA

30.

The term dried to constant weight means that two consecutive weighing do not differ by more than:

a)

0.0002 g

b)

0.2 mg

c)

0.5 mg/g

d)

AOTA

31.

To keep samples moisture free, the appropriate apparatus to use is:

a)

Desiccators

b)

Separatory funnel

c)

Furnace

d)

Incubator

32.

Performs and evaluate microbiological and pharmacological assay, sterility, pyrogen, and bacteriological tests, safety or acute toxicity test.

a)

Material inspection section

b)

Analytical laboratory

c)

Biological testing

d)

Specification & analytical laboratory

33.

Analysis in which separation of the constituents from the sample is done and then weighing the product is:

a)

Volumetric analysis

b)

Instrumental method of analysis

c)

Gravimetric analysis

d)

Special method of analysis

34.

Total Quality Management involves:

a)

A. Continuous improvement

b)

B. Defect prevention

c)

C. Defect detection

d)

A and B

35.

A defect that may endanger life or property and may render the product non-functional.

a)

Ocular

b)

Major

c)

Critical

d)

Attribute

36.

A slight deviation of the color of the label from the color of standards is an example of a:

a)

Minor

b)

Variable

c)

Major

d)

Performance

37.

A sub-potent product is a/an:

a)

A. Critical

b)

B. Major

c)

C. Internal

d)

D. A and B

38.

Include all tests and evaluations performed to ensure that quality has been achieved in a specific lot of production.

a)

QA

b)

QC

c)

TQM

d)

GMP

39.

Describes how close a measured value is to the true value.

a)

Accuracy

b)

Precision

c)

Range

d)

Standard deviation

40.

Other name of systematic error.

a)

Determinate

b)

Indeterminate

c)

Random

d)

NOTA

41.

In analytical methods, the 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 is called:

a)

Linearity

b)

Robustness

c)

Ruggedness

d)

NOTA

42.

This error is due to faulty and uncalibrated pH meter, balances, potentiometers, etc:

a)

Personal

b)

Instrumental

c)

Error of method

d)

Reagent error

43.

This error manifest by slight variation in a series of observation made by the same observer under identical conditions:

a)

A. Indeterminate error

b)

B. Determinate error

c)

C. Random error

d)

D. A and C

44.

It is a measure of reproducibility of data within a series of results:

a)

Accuracy

b)

Precision

c)

Specificity

d)

Reliability

45.

Reasons why residual titration are performed.

a)

A. Reaction proceeds slowly

b)

B. Poor solubility of the sample

c)

C. Sample does not give sharp end point

d)

D. All of the choices

46.

Solution containing all the reagents and solvents used in the analysis, but no deliberately added analyte.

a)

Blank solution

b)

Solution with sample

c)

Standard solution

d)

Test solution

47.

Standard solutions are also known as:

a)

Test solutions

b)

Volumetric solutions

c)

Saturated solutions

d)

None of the choices

48.

Types of chemical reaction used in the volumetric analysis.

a)

Redox

b)

Neutralization

c)

Diazotization

d)

AOTA

49.

HCl + Calcium carbonate will react to form a primary product known as:

a)

A. Carbonic acid

b)

B. Calcium hydroxide

c)

C. Both A and B

d)

D. None of the choices

50.

The reaction between HCl and calcium carbonate can be seen in the standardization of:

a)

Silver nitrate

b)

Ammonium thiocyanate

c)

Edentate disodium

d)

Sulfuric acid

51.

When a weak base is to be titrated with weak acid, the indicator used is:

a)

Phenolphthalein

b)

Methyl orange

c)

Methyl red

d)

No indictor is suggested

52.

The formula to compute the equivalent weight of a reducing agent.

a)

Molecular weight/no. of electrons gain

b)

Molecular weight/no. of electrons loss

c)

Both A and B

d)

NOTA

53.

Residual titration method is also known as:

a)

Direct titration

b)

Indirect titration

c)

Back titration

d)

Redox titration

54.

Titer is an expression of concentration in terms of:

a)

A. g of solute/100 mL

b)

B. g or mg/mL

c)

C. g of solute/L

d)

D. B and C

55.

The indicator used if weak acid is titrated with strong alkali.

a)

Methyl orange

b)

Methyl red

c)

Phenol red

d)

Phenolphthalein

56.

Phenolphthalein in alkali medium is colored:

a)

Yellow

b)

Pink

c)

Colorless

d)

Blue

57.

This analysis is done by dissolving the substance under examination in an accurately measured quantity of standard solution known to be in excess and back titrating the excess solution with another standard solution

a)

Gravimetric

b)

Acidimetric

c)

Direct alkalimetric

d)

Residual

58.

An analyst who determines the strength, potency and percentage purity of a drug or pharmaceutical product is performing:

a)

Special method

b)

Identification tests

c)

Pharmacopeial testing

d)

Pharmaceutical assaying

59.

Two substances reacting upon reaching the end point must have the same:

a)

Normality

b)

Volume

c)

Number of mEq

d)

Weight

60.

Type of titration used in volumetric analysis:

a)

Direct

b)

Residual

c)

Indirect

d)

AOTA

61.

The process of measuring, examining, testing or otherwise comparing the unit of product with the requirements

a)

Inspection

b)

Sampling

c)

Assay

d)

Statistical analysis

62.

The volumetric method of titration, the chemical substance being analyzed is referred to as:

a)

A. Analyte

b)

B. Active constituent

c)

C. Inactive constituent

d)

D. A and B

63.

A chemical which changes color at or very near the end point of titration where equivalent quantities of analyte and titrant have reacted:

a)

A. Methyl orange

b)

B. Chloroform

c)

C. Starch T.S.

d)

D. A and C

64.

The determination of the volume of a solution of known concentration required to react with a given amount of a substance to be analyzed:

a)

Gravimetric

b)

Volumetric

c)

Special method

d)

Instrumental method

65.

Solution of sodium hydroxide or potassium hydroxide may be standardized by the use of a standard solution of _____ as a secondary standard:

a)

Hydrochloric acid

b)

Nitric acid

c)

Glacial acetic acid

d)

Formic acid

66.

The standard alkali solutions commonly used are:

a)

A. Sodium hydroxide

b)

B. Potassium hydroxide

c)

C. Calcium hydroxide

d)

D. A and B

67.

The number of moles of solute per liter of solution is:

a)

Molarity

b)

Molality

c)

Normality

d)

Formality

68.

A secondary standard is a solution of known:

a)

Quality

b)

Purity

c)

Concentration

d)

NOTA

69.

The chemical reactions which serve as the basis of titrimetric analysis:

a)

Neutralization

b)

Precipitation/Complexation

c)

Redox

d)

AOTA

70.

The primary standard used to standardize 1 N Hydrochloric acid is:

a)

Calcium carbonate

b)

Sodium carbonate

c)

Magnesium carbonate

d)

Sodium oxalate

71.

Expression of concentration in volumetric solutions:

a)

A. Normality

b)

B. Titer

c)

C. Molarity

d)

D. A and C

72.

The purpose of using a combination indicators is:

a)

A. To attain a sharp end point

b)

B. To facilitate reaction

c)

C. To attain a complete reaction

d)

D. None of the above

73.

It is defined as the number of moles of solute per kilogram of solvent:

a)

Normality

b)

Molarity

c)

Molality

d)

Titer

74.

It attributes the color change to certain ions an increase of which causes the appearance of new color, and a decrease in which causes the disappearance of a color:

a)

Physiochemical theory

b)

Organic theory

c)

Colloidal theory

d)

NOTA

75.

Sulfamic acid (H2NSO3) is a primary standard that can be used to standardize sodium hydroxide. What is the molarity if 34.26 mL reacts with 0.3337 g of sulfamic acid. MW=97

a)

0.304

b)

0.1004

c)

0.1005

d)

0.403

76.

What is the titer value for 0.05 M calcium chloride with 2 moles of water? MW = 142.9

a)

3.37 mg

b)

7.15 mg

c)

73.5 mg

d)

53.7 mg

77.

How many grams of Cupric (II) Sulfate pentahydrate should be dissolved in a volume of 500 mL to make 8 x 103 M solution? MW = 249.54

a)

0.998

b)

9.98

c)

99.8

d)

109.1

78.

The molarity of concentrated HCl purchased in the laboratory is approximately 12.1 M. How many mL of this reagent should be diluted to 2 L to make 0.1 M?

a)

1.65

b)

6.53

c)

16.53

d)

165.3

79.

A solution with a final volume of 500 mL was prepared by dissolving 25 mL of methanol (density=0.7914g/mL) in chloroform. Calculate the molarity of methanol in the solution. MW= 32

a)

0.12

b)

1.24

c)

12.4

d)

124

80.

The gram-equivalent weight of sodium oxalate (MW = 134 g/mole) is:

a)

67

b)

0.067

c)

0.114

d)

0.026

81.

Calculate the molarity of Sodium nitrite volumetric solution, if 31.6 mL of this solution reacts with 0.5004 g of Sulfanilamide (C6H8N2O2S) to reach an end point. MW of sulfanilamide=172.2

a)

0.09196

b)

0.91960

c)

0.21090

d)

0.01209

82.

The molecular weight of sulfuric acid is 98. Its equivalent weight is:

a)

98

b)

49

c)

0.098

d)

0.049

83.

The molecular weight of NaOH is 40. How many grams of sodium hydroxide pellets are needed to make 500 mL of 1.5 N solution?

a)

20

b)

30

c)

40

d)

60

84.

Developed in 1883, this method of analysis remains as one of the accurate and widely used method for determining nitrogen in substances.

a)

Non-aqueous titrimetry

b)

Precipitation

c)

Redox titration

d)

Kjeldahl method

85.

The measurement of a base of a given sample by titration of standard acid is:

a)

Acidimetry

b)

Alkalimetry

c)

Compleximetry

d)

Redox titration

86.

Assay of zinc oxide is what type of analysis?

a)

Alkalimetric residual

b)

Acidimetric direct

c)

Acidimetric residual

d)

Alkalimetric direct

87.

In the assay of Milk of Magnesia, the indicator used is:

a)

Methylene blue

b)

Methyl orange

c)

Methyl red

d)

Phenolphthalein

88.

A 4.59 mL sample of HCl, specific gravity 1.3, required 50.5 mL of 0.9544 N NaOH in a titration. Calculate the %w/w HCl. MW = 36.45

a)

29%

b)

1%

c)

92%

d)

69%

89.

A 10 mL sample of sulfuric acid solution required 16.85 mL of NaOH solution in a titration. Each mL of the NaOH solution was equivalent to 0.2477 g of potassium hydrogen phthalate. Calculate the sulfuric acid content in %w/w. MW = 98

a)

10%

b)

20%

c)

30%

d)

40%

90.

The Kjeldahl procedure was used to analyze 256 uL of a solution containing 37.9 mg protein/mL. The liberated ammonia was collected in 5 mL of 0.0336 M HCl, and the remaining acid required 6.34 mL of 0.010 M NaOH for complete titration. What is the weight % of nitrogen in the protein? MW = 14

a)

3.86

b)

15.1

c)

51.5

d)

5.65

91.

Complete the reaction: H2C4H4O6 + NaOH ž

a)

Na2C4H4O6

b)

H2O

c)

Both

d)

NOTA

92.

Most suitable indicator to use in the titration of organic acids:

a)

Methyl red TS

b)

Methyl Orange TS

c)

Phenolphthalein TS

d)

AOTA

93.

Hydrolysis products of ASA.

a)

Acetic acid + sodium hydroxide

b)

Acetic acid + salicylic acid

c)

Salicylic acid + sodium hydroxide

d)

Sodium salicylate + water

94.

Assay of ASA (raw material) is an example of what method of analysis?

a)

Direct alkalimety

b)

Residual alkalimetry

c)

Direct acidimetry

d)

Residual acidimetry

95.

The indicator of choice for inorganic acid:

a)

Methyl orange

b)

Methyl red

c)

Crystal violet

d)

Bromocresol green

96.

The indicator used in the assay of Aspirin:

a)

Methyl red

b)

Phenolphthalein

c)

Methyl orange

d)

Phenol red

97.

Blank titration are necessary to:

a)

Correct for the action of the reagent with the titrant

b)

Eliminate errors from different sources

c)

BOTH

d)

NOTA

98.

What weight of arsenic trioxide (98.73%) would be used as a sample so that 26.6 mL of 0.1120N Iodine would be needed to titrate it? MW = 197.46

a)

0.14896

b)

0.4896 g

c)

0.1111 g

d)

0.9145 g

99.

Primary standard in the standardization of perchloric acid.

a)

Potassium hydrogen phthalate

b)

Calcium carbonate

c)

Benzoic acid

d)

Sodium carbonate

100.

Primary standard in the standardization of sodium methoxide.

a)

Benzoic acid

b)

Sodium bicarbonate

c)

Sodium carbonate

d)

Potassium hydrogen phthalate