[PHARMACEUTICAL MANUFACTURING] MANOR

Proverbs 16:3

d. any of the above

1.) A means of administering drugs as formulated preparations is called:

a. pharmaceutical

b. drug delivery system

c. dosage forms

d. any of the above

d. toll manufacturer

2.) A manufacturer who produces the products of a company without manufacturing facilities is a/ an:

a. ethical manufacturer

b. proprietary manufacturer

c. biological manufacturer

d. toll manufacturer

c. AOTA

• are in direct contact with the product

• have a direct effect on product shelf life

3.) Primary package system as differentiated from secondary package systems:

a. are in direct contact with the product

b. have a direct effect on product shelf life

c. AOTA

d. None

a. aerosol containers

4.) The only true tamper resistant packaging:

a. aerosol containers

b. sealed tubes

c. breakable caps

d. shrink seals

b. water for injection

5.) Purified water that is free from pyrogen

a. purified water

b. water for injection

c. Any of the choices

d. NOTA

c. both

• improve pourability of products from container

• improve palatability

6.) Viscosity enhancers are added to liquid preparations to:

a. improve pourability of products from container

b. improve palatability

c. both

d. none

b. SS 316

7.) The most inert grade of stainless steel used for high grade products

a. SS 304

b. SS 316

c. SS 3004

d. SS 3016

c. pressure

8.) Filtration system which is recommended for handling large quantities is

a. gravimetric filtration

b. vacuum

c. pressure

d. cartridge filtration

a. gravimetric filling

9.) Filling method which is advisable for highly viscous products

a. gravimetric filling

b. volumetric filling

c. any of the above

d. none

d. AOTA

• increased therapeutic effects

• increased spreading ability

• ability to mask unpleasant odors

10.) The advantages of emulsion over other dosage forms include:

a. increased therapeutic effects

b. increased spreading ability

c. ability to mask unpleasant odors

d. AOTA

d. granules

11.) Aggregates of powders which adhere or bond to each other to form larger particles

a. powders

b. microcapsules

c. pellets

d. granules

c. AOTA

• 35-50% RH

• 21-25°C

12.) Storage conditions for capsules

a. 35-50% RH

b. 21-25°C

c. AOTA

d. NOTA

b. binder

13.) Substance that "glue powder together causing them to form granules

a. diluent

b. binder

c. lubricant

d. disintegrant

c. lubricant

14.) An agent that acts between surfaces in relative motion to prevent friction and wear

a. diluent

b. binder

c. lubricant

d. disintegrant

c. sweating

15.) In film coating, when additives migrate to the surface, the problem is called:

a. blistering

b. wrinkling

c. sweating

d. bloom

b. airlock

16.) An anteroom which separates the sterile from non sterile is a/an:

a. LAF

b. airlock

c. HEPA

d. AOTA

c. Class 100

17.) Area with no more than 100 particles of 0.5 micron size per cubic foot of environment:

a. Class 0.5

b. Class 500

c. Class 100

d. Class 1000

b. LAL Test

18.) A very simple, sensitive and fast test for pyrogens using the amoebocyte of the horse shoe crab.

a. Pyrogen Test

b. LAL Test

c. Rabbit Test

d. Crab Test

c. any of the above

• Tip sealing

• Pull sealing

19.) Ampules are sealed by:

a. Pull sealing

b. Tip sealing

c. any of the above

d. NOTA

b. Shelf life

20.) The period in which the product remain acceptable for use:

a. Stability

b. Shelf life

c. Accelerated Stability Studies

d. any of the above

a. Viscosity

21.) Flow property of liquid is related to:

a. Viscosity

b. Volatility

c. Optical Property

d. Miscibility

d. any of the above

• Application of heat

• Agitation

• Reduction of particle size

22.) Solubility may be enhanced through the use of:

a. Application of heat

b. Agitation

c. Reduction of particle size

d. any of the above

d. all of the above

• Blender

• Impeller

• Colloid mill

23.) Dispensing equipment in the name of suspension includes:

a. Blenders

b. Impellers

c. Colloid mill

d. all of the above

d. AOTA

• Suspending agents

• Hydrocolloids

• Viscosity enhancing agents

24.) A suspension may be stabilized through the use of:

a. Suspending agents

b. Hydrocolloids

c. Viscosity enhancing agents

d. AOTA

d. Any of the above

• Sedimentation

• Ease of redispersability

• Measuring of Particle size

25.) Suspensions are evaluated by:

a. Sedimentation

b. Ease of redispersability

c. Measuring of Particle size

d. Any of the above

a. Tween 80

📌Natural emulsifying agents include:

• Acacia

• Agar

• Gelatin

26.) The ff are natural emulsifying agent, except:

a. Tween 80

b. Acacia

c Agar

d. gelatin

a. PEG

27.) Water soluble bases are prepared from

a. PEG

b. sorbitol

c. Petrolatum

d. mineral oil

a. humectant in creams

28.) Polyols may be used as:

a. humectant in creams

b. viscosity contribution

c. prevent cap locking

d. AOTA

b. container

📌 Preservatives are added to semisolid preparations to be prevent:

• decomposition

• deterioration

• spoilage by bacteria and molds

29.) Preservatives are added to semisolid preparations to be prevent the ff except

a. decomposition

b. container

c. deterioration

d. spoilage by bacteria and molds

a. Sigma blade mixer

30.) Mixing equipment for acid materials

a. Sigma blade mixer

b. Ribbon blender

c. Twin shell bed dryer

d. AOTA

d. Any of the above

31.) An ideal drug delivery system (DDS) is

a. capable of controlled delivery rates

b. not highly sensitive to physiological variables

c. based on physicochemical principles

d. Any of the above

d. AOTA

• use of coating

• embedding the drug in a matrix

• microencapsulation

32.) Formulation methods of achieving sustained drug release including

a. use of coating

b. embedding the drug in a matrix

c. microencapsulation

d. AOTA

d. any of the above

• chemical reaction

• decomposition

• bacterial growth

33.) Gradual sedimentation in liquid products is due to:

a. chemical reaction

b. decomposition

c. bacterial growth

d. any of the above

a. parallel

34.) Filtration process wherein the liquid passes through one filter pad or disk

a. parallel

b. series

c. both a and b

d. none

a. free flowing

35.) A gravity operated filling set up is used for liquids which are

a. free flowing

b. foaming

c. viscous

d. either a or b

d. AOTA

• application of heat

• agitation

• reduction of particle size

36.) Solubility may be enhanced through

a. application of heat

b. agitation

c. reduction of particle size

d. AOTA

b. humectant

37.) Suspension adjunct used to prevent the product from drying at topical application

a. sweetening agent

b. humectant

c. preservative

d. emollient

d. flocculation

38.) The aggregation of the dispersed globules into loose clusters within the emulsion

a. creaming

b. cracking

c. phase inversion

d. flocculation

d. AOTA

• cover all

• face mask and head covers

• boots and gloves

39.) The attire or uniform used in parenteral production include

a. cover all

b. face mask and head covers

c. boots and gloves

d. AOTA

a. Current Good Manufacturing Practice

40.) CGMP means

a. Current Good Manufacturing Practice

b. Current General Manufacturing Program

c. Current General Manufacturing Practice

d. AOTA

• safety

• effectiveness

• acceptability

41.) The quality of a medicinal and a related product is the sum of all factors which will contribute directly or indirectly to the products

a. safety

b. effectiveness

c. acceptability

d. AOTA

b. Quality assurance

42.) Group which is responsible for auditing the control system for evaluating product quality

a. Quality Control

b. Quality assurance

c. Production

d. Medical

c. Distilled water

43.) The disintegration medium of plain uncoated tablet is

a. simulated gastric fluid TS

b. simulated intestinal fluid TS

c. Distilled water

d. potable water

c. angle of repose

📌Quality control test performed on granules before compression into tablets include:

• Sieve analysis

• Bulk density

44.) Quality control test that are performed on granules before compression into tablets are except:

a. sieve analysis

b. bulk density

c. angle of repose

d. AOTA

d. use double layer tableting

45.) The most common method of tableting active ingredients which are chemically incompatible

a. microencapsulation

b. film coating

c. add stabilizers

d. use double layer tableting

d. a and c

• Pull sealing

• Tip sealing

46.) Sealing of ampule is done by

a. Pull sealing

b. softening the neck of ampule

c. Tip sealing

d. a and c

c. pulbules

47.) Bullet shaped capsules are called

a. spansules

b. bougies

c. pulbules

d. NOTA

a. Sulfur dioxide

48.) This is used to increase the resistance of gas

a. Sulfur dioxide

b. Titanium Oxide

c. Ethylene oxide

d. acid

a. dog

49.) The animal of choice for in vitro rectal absorption studies

a. dog

b. pig

c. rabbit

d. mouse

b. wet granulation

50.) Method that will produce tablets of best quality

a. direct compression

b. wet granulation

c. dry granulation

d. any of the above

c. membrane filter

51.) Bubble test measure the efficiency of:

a. glass

b. plastics

c. membrane filter

d. air filter

a. double impression

52.) A processing problem encountered only in the manufacture of tablets:

a. double impression

b. weight variation

c. molding

d. chipping

a. cracking

53.) The coalescence of oil globules in a o/w emulsion is called:

a. cracking

b. inversion

c. creaming

d. sedimentation

c. they have high HLB values

📌True for spans include:

• They are resistant to addition of acids and electrolytes

• They are hydrophobic

• They form w/o emulsions

54.) The ff. are true for Spans, except:

a. they are resistant to addition of acids and electrolytes

b. they are hydrophobic

c. they have high HLB values

d. they form w/o emulsions

d. Bottle method

55.) A variation of dry gum method of preparing emulsions using volatile oil is added to acacia in a bottle:

a. Oil method

b. English method

c. Emulsifier in oil method

d. Bottle method

а. ВНТ

56.) Antioxidants which block an oxidative chain reaction in which they are not usually consumed:

а. ВНТ

b. EDTA

c. thiourea

d. tartaric acid

a. carbon dioxide

📌Gas sterilants include:

• formaldehyde

• beta propiolactone

• sulfur dioxide

57.) These are gas sterilants, except:

a. carbon dioxide

b. formaldehyde

c. beta propiolactone

d. sulfur dioxide

a. autoclaving

58.) A sterilization method which destroys microorganism by cellular protein coagulation:

a. autoclaving

b. dry heat sterilization

c. gas sterilization

d. none of the above

d. Staphylococcus aureus

📌Usual contaminants of ophthalmic preparations include:

• Pseudomonas aeruginosa

• Bacillus subtilis

• Aspergillus fumigatus

59.) The usual contaminants of ophthalmic preparations are the ff., except:

a. Pseudomonas aeruginosa

b. Bacillus subtilis

c. Aspergillus fumigatus

d. Staphylococcus aureus

a. lactose

60.) A commonly used capsule diluent:

a. lactose

b. starch

c. Calcium Phosphate

d. any of the above

c. titanium oxide

61.) An opacifying agent for capsules:

a. sulfur oxide

b. lactose

c. titanium oxide

d. talc

b. mineral oil

62.) A common levigating agent:

a. glycerin

b. mineral oil

c. alcohol

d. ether

c. geometric dilution

63.) Method used for the incorporation of small amounts of potent drugs with a large amount of diluent:

a. spatulation

b. sifting

c. geometric dilution

d. levigation

b. disintegrant

📌Excipients that impart satisfactory compression characteristics to the tablet formulation include:

• glidant

• lubricant

• antiadhesive

64.) The ff. excipients impart satisfactory compression characteristics to the tablet formulation except:

a. glidant

b. disintegrant

c. lubricant

d. antiadhesive

a. volumetric fill of the disc

65.) Tablet weight is determined by:

a. volumetric fill of the disc

b. pressure during compression

c. amount and nature of bunder

d. all

c. 100-1000

66.) One part of a slightly soluble material will dissolve in ________ part of solvent

a. 10-30

b. 30-100

c. 100-1000

d. 1000-10000

b. spirits

67.) Brandy and whiskey are classified as:

a. elixirs

b. spirits

c. aromatic waters

d. juice

b. pulverization by intervention

68.) The reduction of camphor with the aid of alcohol is called:

a. trituration

b. pulverization by intervention

c. levigation

d. any of the above

d. generic name

69.) The prominently printed element on the label:

a. brand name

b. Rx symbol

c. pharmacologic category

d. generic name

c. 10000

70.) A 600L paracetamol drops was manufactured. If it is packed in 60-mL bottle, the theoretical yield is:

a. 100

b. 1000

c. 10000

d. 5000

a. levulose

71.) Invert sugar has the tendency to darken in color due to:

a. levulose

b. sucrose

c. glucose

d. lactose

a. simple syrup

72.) A near saturated solution of sucrose in water:

a. simple syrup

b. syrup

c. sucrose solution

d. all

b. 35

73.) Acacia mucilage is ____ % dispersion in water:

a. 42

b. 35

c. 5

d. 25

c. gels

74.) Thixotropy is a characteristic demonstrated by:

a. jellies

b. magmas

c. gels

d. suppositories

c. extractives

75.) Galenicals are also called:

a. extracts

b. fluidextracts

c. extractives

d. marc

a. hypodermicyclics

76.) The injection of large of volumes of a solution into substances tissue to provide a continuous, abundant drug supply is called:

a. hypodermicyclics

b. IV administration

c. IM administration

d. intradermal administration

d. all

• bioavailability

• disintegration

• dissolution

77.) Excessive use of binders in tablet affect:

a. bioavailability

b. disintegration

c. dissolution

d. all

c. binder

78.) Impart cohesive qualities to the tablet granulation:

a. diluent

b. lubricant

c. binder

d. disintegrant

a. swallow

79.) Buccal tablets are intended to be dissolved:

a. swallow

b. rapidly

c. beneath the tongue

d. chewed

a. electrolyte

📌Necessary components of a stable emulsion include:

• Dispersion medium

• Dispersed phase

• Emulsifier

80.) These are necessary components of a stable emulsion, except:

a. electrolyte

b. dispersion medium

c. dispersed phase

d. emulsifier

a. caking

81.) Problem often encountered in suspensions:

a. caking

b. smooth texture

c. slow settling

d. dispersatility

a. Dry Gum

📌Different methods of determining emulsion type include:

• Drop dilution

• Electrical conductivity

• Dye

82.) The different methods of determining the emulsion type are the ff., except:

a. Dry Gum

b. Drop dilution

c. Electrical conductivity

d. Dye

b. glass

83.) The container of choice for parenteral:

a. plastic

b. glass

c. metals

d. tubes

c. collapsible tubes

84.) The container of choice for ointments:

a. jars

b. cans

c. collapsible tubes

d. widemouth bottle

a. lactose

📌Examples of Lubricant:

• Stearic acid

• Ca Stearate

• Talc

85.) Which of the ff. is NOT classified as a lubricant?

a. Lactose

b. Stearic acid

c. Ca Stearate

d. Talc

d. surfactants

86.) Spans & Tweens are:

a. binders

b. diluents

c. preservatives

d. surfactants

a. polishing

87.) Filtration of a solution to a high degree of clarity:

a. polishing

b. dialysis

c. clarification

d. dissolution

d. all of the above

• vapors permeate through the walls of the container

• leaching of constituents from the plastic to the product

• absorption of the drug molecules to the surface of the plastic

88.) Plastic containers are not recommended for pharmaceuticals because:

a. vapors permeate through the walls of the container

b. leaching of constituents from the plastic to the product

c. absorption of the drug molecules to the surface of the plastic

d. all of the above

e. none of the above

d. prolonged dissolution

📌Advantages of tablets include:

• Economy

• Accuracy

• Blandness of taste

89.) These are advantages of tablets, except:

a. economy

b. accuracy

c. blandness of taste

d. prolonged dissolution

c. air

90.) HEPA filters are used for filtration of:

a. parenterals

b. ophthalmics

c. air

d. solvents

d. punches

91.) For compacting the materials in the tablet machine:

a. hopper

b. feedframe

c. dies

d. punches

c. fluid bed dryer

92.) Tablet granulations can be dried faster using:

a. granulator

b. oven

c. fluid bed dryer

d. solar dryer

b. capping

93.) The partial or complete separation of the top or bottom of a tablet from the main body:

a. chipping

b. capping

c. lamination

d. picking

b. V-blender

94.) Used for mixing powder mixtures in large volume quantity:

a. drum roller

b. V-blender

c. planetary mixer

d. compactor mills

a. ointment

95.) A roller mill is used to reduce the particle size of powders in:

a. ointment

b. tablet

c. capsules

d. emulsion

b. price per dosage unit

📌Some parts of master formula record include:

• Complete batch formula

• Weight of each

• Description of container & closure

96.) This is not part of the master formula record:

a. complete batch formula

b. price per dosage unit

c. weight of each

d. description of container & closure

b. subcoating

97.) This part of the sugar coating process is to round off tablet contours rapidly:

a. sealing

b. subcoating

c. syruping

d. finishing

e. polishing

A. 18kg

98.) Formula mg/tab of 600,000 tabs

————— Primaquine PO4 30

A. 18kg

B. 33.96kg

C. 9.96 kg

D. 0.342 kg

E. 0.138kg

F. 104mg

B. 33.96kg

99.) Formula mg/tab of 600,000 tabs

————— Lactose 56.6

A. 18kg

B. 33.96kg

C. 9.96 kg

D. 0.342 kg

E. 0.138kg

F. 104mg

C. 9.96 kg

100.) Formula mg/tab of 600,000 tabs

————— Starch 16.6

A. 18kg

B. 33.96kg

C. 9.96 kg

D. 0.342 kg

E. 0.138kg

F. 104mg