Font size
S
M
L
XL
WorksheetsMODULE 5 MANUFACTURING PINK 201 - 300
Total questions: 100
Worksheet time: 50mins
Name
Class
Date
1.
A batch or any portion of a batch of drug produced by a continuous process is:
a)
a. Lot
b)
b. Component
c)
c. Inert substances
d)
d. Active ingredient
e)
e. Product
2.
The records to be controlled by Quality Control should be:
a)
a. Master formula
b)
b. Inventory records
c)
c. Returned goods
d)
d. Production records
e)
e. In-process records
3.
A semisolid vehicle recognized by the USP/NF is:
a)
a. Glycerogelatin base
b)
b. Water-soluble base
c)
c. Alcohol soluble fats
d)
d. Non-absorption base
e)
e. Fats and oils
4.
Fever producing substances arising from microbial contamination are:
a)
a. Bacteria
b)
b. Fungi
c)
c. Pyrogens
d)
e. Coliform organisms
e)
d. Yeast
5.
Classified as sterile product although not injected into the body is:
a)
a. Ophthalmic preparation
b)
b. Biological product
c)
c. Ointment
d)
d. Gargle
e)
e. Dextrose injection solution
6.
Sealing of ampoules is done by:
a)
a. Heating the neck of the ampoules
b)
b. Pull sealing
c)
c. Pressing the ampoule tip
d)
d. Gas sealing
e)
e. Alcohol-flame seal
7.
A tablet processing problem where a partial or complete separation of the top or bottom of the table is termed:
a)
a. Elimination
b)
b. Capping
c)
c. Picking
d)
d. Sticking
e)
e. Breaking
8.
To control microorganisms in the air is to:
a)
a. Install UV lamps in several areas
b)
b. Install IR lamps in the areas
c)
c. Provide ETO gas around the room
d)
d. Close the door tightly
e)
e. Spray insecticide inside the room
9.
Products which have been bottled or stripped-packed but not yer labelled or packed into boxes or barbons are termed:
a)
a. Finished products
b)
b. Releasable for sale
c)
c. In-process
d)
d. Rejected products
e)
e. For processing
10.
Advantage of plastic containers over glass is:
a)
a. Permeability
b)
b. Susceptible to microorganisms growth
c)
c. High transportation cost
d)
d. Lightness in weight
e)
e. Light can penetrate easily
11.
Egg yolk is an example of an emulsifier belonging to:
a)
a. Non-ionic type
b)
b. Finely divided liquid
c)
c. Synthetic group
d)
d. Ionic type
e)
e. Natural group
12.
Lyophilized products are manufacture by series of processes as:
a)
a. Freezing
b)
b. Melting
c)
c. Cooking
d)
d. Compression
e)
e. Mixing
13.
A HEPA filter is used to filter air entering a:
a)
a. Gas chamber
b)
b. Laminar flow hood
c)
c. Fume hood
d)
d. Sterile room
e)
e. Clean room
14.
The size of a single-dose container for injection is limited to:
a)
a. 30 ml
b)
b. 50 ml
c)
c. 1000 ml
d)
d. 20 ml
e)
e. 60 ml
15.
An indicator employed in sterilization process is:
a)
a. Methyl red TS
b)
b. Litmus paper
c)
c. Phenolphthalein TS
d)
d. Colored cloth
e)
e. Colored paper strips
16.
Coating of tablets that allow disintegration in the intestines is:
a)
a. Sugar
b)
b. Enteric
c)
c. Film
d)
d. Chocolate
e)
e. Gelatine
17.
To protect the contents of a bottle from the action of light id to use:
a)
a. Flint glass
b)
b. Green colored glass
c)
c. Colorless glass
d)
d. Amber colored glass
e)
e. Plastic coated glass
18.
A lyophobic substance is easily wet by:
a)
a. Polar solvents
b)
b. Water
c)
c. Non-polar solvents
d)
d. Hydroalcohol
e)
e. Alcohol-water mixture
19.
In tablet compression, the large, poorly formed, compacted mass of powder is referred to as:
a)
a. Slugs
b)
b. Buccal tablets
c)
c. Vaginal tablets
d)
d. Compressed tablets
e)
e. Lozenges
20.
Content uniformity test for tablets, USP/NF limit is:
a)
a. 90-110%
b)
b. 95-105%
c)
c. 90-100%
d)
d. 85-105%
e)
e. 85-115%
21.
The best choice of disintegrant by the formulators is:
a)
a. Lactose
b)
b. Starch
c)
c. Stearic acid
d)
d. Talc
e)
e. Sucrose
22.
The dispensing division of the warehouse requires a:
a)
a. Licensed chemist
b)
b. Experienced scientist
c)
c. Licensed pharmacist
d)
d. Any skilled technician
e)
e. Male engineer
23.
Room temperature recognized by USP/NF is:
a)
a. 20 °C
b)
b. 15-20 °C
c)
c. Temp. Of the working area
d)
d. 25 °C
e)
e. 30 °C
24.
A protective colloid added to a suspension formulation is to:
a)
a. Allow for fast sedimentation
b)
b. Allow active constituent to easily separate
c)
c. Allow solution of the sediment
d)
d. For easy measurement of final volume of the preparation
25.
Effervescent tablets when added to water releases:
a)
a. Oxygen
b)
b. Hydrogen
c)
c. Nitrogen
d)
d. Gas
e)
e. Carbon dioxide
26.
In labelling of a product, an unlabelled portion is provided for:
a)
a. Viewing the contents
b)
b. Elegance
c)
c. Save cost of label
d)
d. Art design
e)
e. Saving of glue applied
27.
Property of IV solutions:
a)
a. Hypotonic
b)
b. Isotonic
c)
c. Non-aqueous vehicle
d)
d. Hypertonic
e)
e. Hydroalcoholic vehicle
28.
The material present in both enteric and film coating is:
a)
a. Wax
b)
b. Paraffin wax
c)
c. Cellulose acetate phthalate e. Sugar
d)
d. Vaseline
29.
The Inspection and Checking section of Quality Control is responsible for:
a)
a. Checking sterility of materials
b)
b. Doing pyrogen testing
c)
c. Chemical assaying
d)
d. Analyzing finished products sampled
e)
e. Sampling of raw materials delivered by suppliers
30.
To determine whether the product has undergone stability studies, the label indicates the:
a)
a. Expiry date
b)
b. Bar marks
c)
c. DR. No.
d)
d. Control number
e)
e. Lot number
31.
Required characteristic of surfaces of equipments used in production:
a)
a. Reactive with substances of the formulation
b)
b. Non-absorptive
c)
c. Absorbs the excipients of the formulation
d)
d. Turns dark with some constituents
e)
e. Made of plastic covering
32.
The water used to prepare parenteral products must be:
a)
a. Water, USP
b)
b. Distilled water
c)
c. Water for injection
d)
d. Demineralised water
e)
e. Purified water
33.
To control raw materials and finished products in the warehouse, the practice of:
a)
a. First in-last out
b)
b. Last in-last out
c)
c. Last in-first out
d)
d. First in-first out
e)
e. As decided by the supervisor
34.
Uneven distribution of color on the surface of tablets:
a)
a. Peeling
b)
b. Mottling
c)
c. Capping
d)
d. Lamination
e)
Picking
35.
To control raw materials and finished products in the warehouse, the practice of:
a)
a. First in-last out
b)
b. Last in-last out
c)
c. Last in-first out
d)
d. First in-first out
e)
e. As decided by the supervisor
36.
Uneven distribution of color on the surface of tablets:
a)
a. Peeling
b)
b. Mottling
c)
c. Capping
d)
d. Lamination
e)
e. Picking
37.
To remedy the irritating effects of UV radiation is to:
a)
a. Wear UV goggles
b)
b. Wear mask
c)
c. Wear any type of eyeglass to cover the eyes
d)
d. Wear head cap
e)
e. Wear contact glasses
38.
Part of a tablet machine which controls the size and shape of a tablet is:
a)
a. Hopper
b)
b. Punches
c)
c. Cam
d)
d. Die
e)
e. Upper punch
39.
Moist heat sterilization is more effective than dry heat oven at a lower temperature due to:
a)
a. Weakening of organisms by moist heat
b)
b. Non-oxidation of organisms heat
c)
c. Destruction of the carbohydrates of the cell wall of the organisms
d)
d. Dissolution of the organisms in liquid form
e)
e. Non-precipitation of the proteins
40.
The more preferred type of suspension is the flocculated one due to:
a)
a. Elegant in appearance
b)
b. Forms a hard cake upon standing
c)
c. No need of shaking before use
d)
d. Not easy to resuspend
e)
e. Easy resuspendability
41.
A 50-kg ointment may be manufactured by:
a)
a. Spatulation
b)
b. Trituration
c)
c. Fusion
d)
d. Use of mixer
e)
e. Use of big mortar and pestle
42.
Strength of a product is expressed in terms of:
a)
a. Potency
b)
b. Activity
c)
c. Toxicity
d)
d. Therapeutic use
e)
e. Lethal dose
43.
The non-proprietary name of a drug product also refers to:
a)
a. Common name
b)
b. Official name
c)
c. Brand name
d)
d. Local name
e)
e. Herbal name
44.
Certified colorants used for drugs and cosmetics but not food is:
a)
a. FD & C dyes
b)
b. Internally D & C dyes
c)
c. Eosin Y
d)
d. D&C dyes
e)
e. Fluorescin dyes
45.
The part of the transdermal drug delivery system patch where the drug is stored:
a)
a. Back strip
b)
b. Membrane part
c)
c. Peel strip
d)
d. Gauze part
e)
e. Reservoir
46.
OTC labels of products indicate in front of the:
a)
a. Expiry date
b)
b. Formula
c)
c. Pharmacologic category
d)
d. Storage
e)
e. Manufacturing date
47.
Part of the tablet machine which holds the granules:
a)
a. Punch
b)
b. Cam
c)
c. Die
d)
d. Vessel
e)
e. Hopper
48.
The most useful preservative that is effective against bacteria and molds is:
a)
a. Parabens
b)
b. Sodium benzoate
c)
c. Glycerine
d)
d. Alcohol
e)
e. Propanol
49.
Solutions which are intended to be freeze-dried must be:
a)
a. Hydroalcoholic
b)
b. Oily
c)
c. Aqueous
d)
d. Combination of oil and alcohol
e)
e. Ether-chloroform mixture
50.
The building used for manufacturing of pharmaceuticals shall be of adequate space for:
a)
a. Orderly placement of materials
b)
b. Allowance of mix-ups of drugs
c)
c. Allow-for cross-contamination of raw materials ad labels
d)
d. Allowance of big quantities of products to mix raw materials
e)
e. Use as rest area of some personnel
51.
A biological indicator used during sterilization process consist of:
a)
a. Killed microorganisms
b)
b. Attenuated microorganisms
c)
c. Inactivated microorganisms
d)
d. Live microorganisms
e)
e. Mixed live inactivated microorganisms
52.
A characteristics of indicator paper strips used during sterilization process is:
a)
a. Destroyed at 121.0 °C
b)
b. Melts at 121.0 °C
c)
c. Turns at 121.0 °C
d)
d. Does not change color at high temperature
e)
e. Changes color at 121.0 °C
53.
Pharmaceutical aerosols may be in the form of:
a)
a. Solutions in oil
b)
b. Emulsions
c)
c. Deffloculated suspensions
d)
d. Granules
e)
e. Small tablets
54.
Hemodialysis is employed to remove toxins from the:
a)
a. Peritoneal cavity
b)
b. Kidney
c)
c. Blood
d)
d. Stomach
e)
e. Intestines
55.
Petroleum jelly is a semisolid belonging to the class:
a)
a. Water soluble base
b)
b. Absorption base
c)
c. Water removable base
d)
d. Hydrocarbon base
e)
e. Alcohol soluble base
56.
Antibiotics and insulin products can be released for distribution by:
a)
a. BFAD
b)
b. Q.C of the company
c)
c. Production head
d)
d. Marketing head
e)
e. Plant manager
57.
The Board of Trustees of a company functions as a:
a)
a. Active planning
b)
b. Preparer of policies
c)
c. Owns the company
d)
d. Stockholder’s money keepers
e)
e. Helps in the marketing of products
58.
Control records required in the manufacture of drugs:
a)
a. Distribution records
b)
b. Sales records
c)
c. Master formula
d)
d. Assay procedures
e)
e. BFAD records
59.
A product that is rubbed or sprayed on the body for cleansing and beautifying is:
a)
a. Liniments
b)
b. Poultices
c)
c. Ointments
d)
d. Therapeutic emulsions
e)
e. Cosmetics
60.
Method of tablet manufacture for easily compressible or adhesive ingredients is:
a)
a. Direct compression
b)
b. Slugging
c)
c. Wet method
d)
d. Dry method
e)
e. Manual process
61.
Gas used to sterilize plastic materials is:
a)
a. Oxygen
b)
b. Carbon dioxide
c)
c. Ethane
d)
d. Ethylene oxide
e)
e. Carbon monoxide
62.
Colorants are added to formulation for:
a)
a. Meeting BFAD requirements
b)
b. Trying which of them is suitable for the product
c)
c. Satisfying the request of marketing department
d)
d. Research during manufacturing
e)
e. Aesthetic purpose
63.
Practical methods of determining hardness of tablets is:
a)
a. Eureka tester
b)
b. Rule of the thumb
c)
c. Pfizer tester
d)
d. Roche tester
e)
e. Pound with a pestle
64.
Use of buffers in parenterals:
a)
a. Tonicity contributor
b)
b. To determine pH of the solution
c)
c. Sterilizer
d)
d. As diluents
e)
e. To make hypotonic solution
65.
The capsule shell is a basically composed of:
a)
a. Gelatin
b)
b. Wax
c)
c. Plasticizer with alcohol
d)
d. Water
e)
e. Petrolatum
66.
Humectant for creams is:
a)
a. Distilled water
b)
b. Oil
c)
c. Sorbitol
d)
d. Chloroform
e)
e. Petroleum jelly
67.
Characteristic of irrigation solutions to wash wounds and surgical opening may be:
a)
a. Boiled for 30 minutes
b)
b. With additives
c)
c. Mixed with antibiotics
d)
d. Pyrogen-free
e)
e. With suspended fine particles
68.
Plastic material used ophthalmic solutions as package and applicator is:
a)
a. Polypropylene
b)
b. Polyethylene
c)
c. Polystyrene
d)
d. PVC
e)
e. Any fine plastic material
69.
A colloid mill is used for:
a)
a. Granulation
b)
b. Tablet compressor
c)
c. Produce fine granules
d)
d. Microencapsulation
e)
e. Homogenization of viscous emulsions
70.
To control foam in emulsions is to:
a)
a. Add polyethylene glycol
b)
b. Add foaming agent
c)
c. Apply compressed air
d)
d. Mix or agitate rapidly
e)
e. Add sorbitol
71.
Thickness of tablets is controlled to avoid the problem in:
a)
a. Packaging
b)
b. Dissolution
c)
c. Disintegration
d)
d. Compression
e)
e. Hardness
72.
Tablets placed beneath the tongue in administration is:
a)
a. Buccal
b)
b. Troches
c)
c. Chewable
d)
d. Sublingual
e)
e. Oral
73.
Caps used to hold rubber closure in place for vials are made of:
a)
a. Tin
b)
b. Aluminium
c)
c. Copper
d)
d. Tin coated metal
e)
e. Plastic coated tin
74.
Quarantined materials delivered in the warehouse are:
a)
a. Subject to test and assays
b)
b. Releasable to production department
c)
c. Rejectable
d)
d. In-process products
e)
e. For approval by the BFAD
75.
Hard gelatin capsules are also referred to as:
a)
a. Elastic capsule
b)
b. Pork skin capsule
c)
c. Dry-filled capsule
d)
d. SEC type capsule
e)
e. Soft capsule
76.
Implantation pellets are those which contains:
a)
a. Diluents
b)
b. Base
c)
c. Disintegrant
d)
d. Active constituent
e)
e. Lubricant
77.
In the manufacture of semisolid emulsions, the mixing of the oil and the aqueous phases is done at a temperature of:
a)
a. 30-40°C
b)
b. 80°C
c)
c. 90-100°C
d)
d. Just to melt
e)
e. 70-72°C
78.
Water can be purified by:
a)
a. Chemical reaction
b)
b. Distillation
c)
c. Solution by boiling
d)
d. By freezing
e)
e. By adding preservative
79.
An emulsifier suitable for water in oil emulsion should have an HLB value of:
a)
a. 8-18
b)
b. 3-6
c)
c. 5-6
d)
d. 10-20
e)
e. 9-10
80.
Property of a tablet granulations to obtain good tablets:
a)
a. Fine granules
b)
b. Well-mixed with lubricant
c)
c. Contain large quantities of fines compressibility
d)
d. Compressibility
e)
e. Uneven sized particles
81.
Stokes Monsanto tester of tablets is to measure:
a)
a. Thickness
b)
b. Friability
c)
c. Hardness
d)
d. Disintegration
e)
e. Dissolution
82.
In ampule sealing, excessive heating of the ampule after it is closed will result to:
a)
a. Fragile bubble
b)
b. Fracture at the neck
c)
c. Leaker
d)
d. Deposit of carbon
e)
e. Ampul-break up
83.
Substances that prevent bacterial and fungal growth are:
a)
a. Coloring agents
b)
b. Flavorants
c)
c. Sweeteners
d)
d. Antioxidants
e)
e. Preservative
84.
To assist in assuring the stability of the dosage forms during transport and storage, the label shall indicate:
a)
a. Expiry date
b)
b. Storage caution
c)
c. Concentration of drug substance
d)
d. Bar marks
e)
e. Transport caution
85.
Pyrogens may come from:
a)
a. Water
b)
b. Pure solute
c)
c. Sterile container
d)
d. Gowns which has been sterilized
e)
e. Air
86.
Temperature that can destroy pyrogens is:
a)
a. 180°C
b)
b. 250°C
c)
c. 650°C for 60 seconds
d)
d. 150°C for 1 hour
e)
e. 500°C for one minute
87.
Insoluble powders for ophthalmic preparations must be:
a)
a. Less than 20 microns in particle size
b)
b. Pyrogen-free
c)
c. Give preservative action
d)
d. Impalpable to the touch
e)
e. Less than 100 microns size
88.
Dialysis solutions as life-saving preparations had the following characterisitics:
a)
a. Requires semi permeable membrane to separate one substance to one another
b)
b. Contains several active ingredients
c)
c. Used to separate red blood cell from white corpuscles
d)
d. Used to individuals with lung diseases
e)
e. Used for any other ailments
89.
Large volume parenterals are employed for:
a)
a. Prophylactic therapy
b)
b. Nutritional use
c)
c. Heart diseased patients
d)
d. For children’s needs
e)
e. Replacement therapy
90.
In semisolid preparations, petrolatum is a common hydrocarbon base due to its:
a)
a. Property of being easily washed by water
b)
b. Consistency
c)
c. Low cost
d)
d. Can be used for other purposes
e)
e. Easily available
91.
To increase viscosity of the aqueous phase of an emulsion is to:
a)
a. Add more oil
b)
b. Add more water
c)
c. Add more emulsifier
d)
d. Stir vigorously
e)
e. Use mixer to stir well
92.
LAL method of test is specified for:
a)
a. Bacteria
b)
b. Molds
c)
c. Virus
d)
d. Yeast
e)
e. Pyrogens
93.
Sterilization process for heat sensitive parenterals is by:
a)
a. Dry heat
b)
b. Membrane filtration
c)
c. Tyndallisation
d)
d. Inspissations
e)
e. Add preservatives
94.
Advantage of multilayered tablets:
a)
a. High cost but effective
b)
b. May be coated
c)
c. 2 incompatibe drugs may keptseparate
d)
d. May separate in 2 layers
e)
e. Lamination may occur
95.
This is a common lubricant for tablets:
a)
a. Magnesium stearate
b)
b. Acacia
c)
c. Talc
d)
d. Starch
e)
e. Mannitol
96.
A container which holds the drug and is in direct contact with the preparation is:
a)
a. Secondary container component
b)
b. Packaging container
c)
c. Tertiary container component
d)
d. Primary container
e)
e. Plastic container
97.
Uniformity of dosage units of suspensions is determined by performing the:
a)
a. Weight variation test
b)
b. Fill volume
c)
c. Content uniformity
d)
d. Viscosity determination
e)
e. Assay process
98.
Filter aids for clarification of liquids include:
a)
a. Starch
b)
b. Fuller’s earth
c)
c. Aorbitol
d)
d. Sugar
e)
e. Lactose
99.
Synthetic drug carrier system include:
a)
a. Injectable particulate
b)
b. Ophthalmic ointment
c)
c. Transdermal delivery systems
d)
d. Lozenges
e)
e. Poultices
100.
Implantation tablets which are administered:
a)
a. Orally
b)
b. Rectally
c)
c. Insertion into body tissues
d)
d. Through the vagina
e)
e. Under the tongue
Reset
