PHARMACEUTICAL MANUFACTURING

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

a. pharmaceutical c. dosage forms
b. drug delivery system d. any of the above

D 2. A manufacturer who produces the products of a company without manufacturing facilities is a/ an:
a. ethical manufacturer c. biological manufacturer
b. proprietary manufacturer d. toll manufacturer

C 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 4. The only true tamper resistant packaging:

a. aerosol containers c. breakable caps
b. sealed tubes d. shrink seals

B 5. Purified water that is free from pyrogen

a. purified water c. Any of the choices
b. water for injection d. NOTA

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

a. improve pourability of products from container
b. improve palatability
c. both
d. none

B 7. The most inert grade of stainless steel used for high grade products
a. SS 304 c. SS 3004
b. SS 316 d. SS 3016

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

a. gravimetric filtration c. pressure
b. vacuum d. cartridge filtration

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

a. gravimetric filling c. any of the above
b. volumetric filling d. none

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

a. increased therapeutic effects c. ability to mask unpleasant odors
b. increased spreading ability d. AOTA

D 11. Aggregates of powders which adhere or bond to each other to form larger particles
a. powders c. pellets
b. microcapsules d. granules

C 12. Storage conditions for capsules

a. 35-50% RH c. AOTA
b. 21-25ºC d. NOTA

B 13. Substance that “glue” powder together causing them to form granules
a. diluent c. lubricant
b. binder d. disintegrant

C 14. An agent that acts between surfaces in relative motion to prevent friction and wear
a. diluent c. lubricant
b. binder d. disintegrant

C 15. In film coating, when additives migrate to the surface, the problem is called:
a. blistering c. sweating
b. wrinkling d. bloom

B 16. An anteroom which separates the sterile from non sterile is a/an:
a. LAF c. HEPA
b. airlock d. AOTA

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

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a. Class 0.5 c. Class 100

b. Class 500 d. Class 1000

B 18. A very simple, sensitive and fast test for pyrogens using the amoebocyte of the horse shoe crab.
a. Pyrogen Test c. Rabbit Test
b. LAL Test d. Crab Test

C 19. Ampules are sealed by:

a. Pull sealing c. any of the above
b. Tip sealing d. NOTA

B 20. The period in which the product remain acceptable for use:
a. Stability c. Accelerated Stability Studies
b. Shelf life d. any of the above

A 21. Flow property of liquid is related to:

a. Viscosity c. Optical Property
b. Volatility d. Miscibility

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

a. Application of heat c. Reduction of particle size
b. Agitation d. any of the above

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

a. Blenders c. Colloid mill
b. Impellers d. all of the above

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

a. Suspending agents c. Viscosity enhancing agents
b. Hydrocolloids d. AOTA

D 25. Suspensions are evaluated by:

a. Sedimentation c. Measuring of Particle size
b. Ease of redispersability d. Any of the above

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

a. Tween 80 c Agar
b. Acacia d. gelatin

A 27. Water soluble abases are prepared from

a. PEG c. Petrolatum
b. sorbitol d. mineral oil

A 28. Polyols may be used as:

a. humectant in creams c. prevent cap locking
b. viscosity contribution d. AOTA

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

a. decomposition c. deterioration
b. container d. spoilage by bacteria and molds

A 30. Mixing equipment for acid materials

a. Sigma blade mixer c. Twin shell bed dryer
b. Ribbon blender d. AOTA

D 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 32. Formulation methods of achieving sustained drug release including

a. use of coating c. microencapsulation
b. embedding the drug in a matrix d. AOTA

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

a. chemical reaction c. bacterial growth
b. decomposition d. any of the above

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A 34. Filtration process wherein the liquid passes through one filter pad or disk
a. parallel c. both a and b
b. series d. none

A 35. A gravity operated filling set up is used for liquids which are
a. free flowing c. viscous
b. foaming d. either a or b

D 36. Solubility may be enhanced through

a. application of heat c. reduction of particle size
b. agitation d. AOTA

B 37. Suspension adjunct used to prevent the product from drying at topical application
a. sweetening agent c. preservative
b. humectant d. emollient

D 38. The aggregation of the dispersed globules into loose clusters within the emulsion
a. creaming c. phase inversion
b. cracking d. flocculation

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

a. cover all c. boots and gloves
b. face mask and head covers d. AOTA

A 40. CGMP means

a. Current Good Manufacturing Practice
b. Current General Manufacturing Program
c. Current General Manufacturing Practice

D 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 c. acceptability
b. effectiveness d. AOTA

B 42. Group which is responsible for auditing the control system for evaluating product quality
a. Quality Control c. Production
b. Quality assurance d. Medical

C 43. The disintegration medium of plain uncoated tablet is

a. simulated gastric fluid TS c. Distilled water
b. simulated intestinal fluid TS d. potable water

C 44. Quality control test that are performed on granules before compression into tablets are except:
a. sieve analysis c. angle of repose
b. bulk density d. AOTA

D 45. The most common method of tableting active ingredients which are chemically incompatible
a. microencapsulation c. add stabilizers
b. film coating d. use double layer tableting

D 46. Sealing of ampule is done by

a. Pull sealing c. Tip sealing
b. softening the neck of ampule d. a and c

C 47. Bullet shaped capsules are called

a. spansules c. pulbules
b. bougies d. NOTA

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

a. Sulfur dioxide c. Ethylene oxide
b. Titanium Oxide d. acid

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

a. dog c. rabbit
b. pig d. mouse

B 50. Method that will produce tablets of best quality

a. direct compression c. dry granulation
b. wet granulation d. any of the above

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C 51. Bubble test measure the efficiency of:

a. glass c. membrane filter
b. plastics d. air filter

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

a. double impression c. molding
b. weight variation d. chipping

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

a. cracking c. creaming
b. inversion d. sedimentation

C 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 from w/o emulsions

D 55. A variation of dry gum method of preparing emulsions using volatile oil is added to acacia in a bottle:
a. Oil method c. Emulsifier in oil method
b. English method d. Bottle method

A 56. Antioxidants which block an oxidative chain reaction in which they are not usually consumed:
a. BHT c. thiourea
b. EDTA d. tartaric acid

A 57. These are gas sterilants, except:

a. carbon dioxide c. beta propiolactone
b. formaldehyde d. sulfur dioxide

A 58. A sterilization method which destroys microorganism b y cellular protein coagulation:

a. autoclaving c. gas sterilization
b. dry heat sterilization d. none of the above

D 59. The usual contaminants of ophthalmic preparations are the ff., except:
a. Pseudomonas aeruginosa c. Aspergillus fumigatus
b. Bacillus subtilis d. Staphylococcus aureus

A 60. A commonly used capsule diluent:

a. lactose c. Calcium Phosphate
b. starch d. any of the above

C 61. An opacifying agent for capsules:

a. sulfur oxide c. titanium oxide
b. lactose d talc

B 62. A common levigating agent:

a. glycerin c. alcohol
b. mineral oil d. ether

C 63. Method used for the incorporation of small amounts of potent drugs with a large amount of diluent:
a. spatulation c. geometric dilution
b. sifting d. levigation

B 64. The ff. excipients impart satisfactory compression characteristics to the tablet formulation except:
a. glidant c. lubricant
b. disintegrant d. antiadhesive

A 65. Tablet weight is determined by:

a. volumetric fill of the disc c. amount and nature of bunder
b. pressure during compression d. all

C 66. One part of a slightly soluble material will dissolve in ________ part of solvent
a. 10-30 c. 100-1000
b. 30-100 d. 1000-10000

B 67. Brandy and whiskey are classified as:

a. elixirs c. aromatic waters
b. spirits d. juice

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

a. trituration c. levigation
b. pulverization by intervention d. any of the above

D 69. The prominently printed element on the label:

a. brand name c. pharmacologic category
b. Rx symbol d. generic name

C 70. A 600L paracetamol drops was manufactured. If it is packed in 60-mL bottle, the theoretical yield is:
a. 100 c. 10000
b. 1000 d. 5000

A 71. Invert sugar has the tendency to darken in color due to:
a. levulose c. glucose
b. sucrose d. lactose

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

a. simple syrup c. sucrose solution
b. syrup d. all

B 73. Acacia mucilage is x% dispersion in water:

a. 42 c. 5
b. 35 d. 25

C 74. Thixotropy is a characteristic demonstrated by:

a. jellies c. gels
b. magmas d. suppositories

C 75. Galenicals are also called:

a. extracts c. extractives
b. fluidextracts d. marc

A 76. The injection of large of volumes of a solution into substances tissue to provide a continuous, abundant
drug supply is called:
a. hypodermicyclics c. IM administration
b. IV administration d. intradermal administration

D 77. Excessive use of binders in tablet affectd:

a. bioavailability c. dissolution
b. disintegration d. all

C 78. Impart cohesive qualities to the tablet granulation:

a. diluent c. binder
b. lubricant d. disintegrant

A 79. Buccal tablets are intended to be dissolved:

a. swallow c. beneath the tongue
b. rapidly d. chewed

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

a. electrolyte c. dispersed phase
b. dispersion medium d. emulsifier

A 81. Problem often encountered in suspensions:

a. caking c. slow settling
b. smooth texture d. dispersatility

A 82. The different methods of determining the emulsion type are the ff., except:
a. Dry Gum c. Electrical conductivity
b. Drop dilution d. Dye

B 83. The container of choice for parenteral:

a. plastic c. metals
b. glass d tubes

C 84. The container of choice for ointments:

a. jars c. collapsible tubes
b. cans d. widemouth bottle

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A 85. Which of the ff. is not classified as a lubricant?

a. lactose c. Ca Stearate
b. Stearic acid d. talc

D 86. Spans & Tweens are:

a. binders c. preservatives
b. diluents d. surfactants

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

a. polishing c. clarification
b. dialysis d. dissolution

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

a. vapors permeate through the walls of the container
b. leeching 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 89. These are advantages of tablets, except:

a. economy c. blandness of taste
b. accuracy d. prolonged dissolution

C 90. HEPA filters are used for filtration of:

a. parenterals c. air
b. ophthalmics d. solvents

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

a. hopper c. dies
b. feedframe d punches

C 92. Tablet granulations can be dried faster using:

a. granulator c. fluid bed dryer
b. oven d. solar dryer

B 93. The partial or complete separation of the top or bottom of a tablet from the main body:
a. chipping c. lamination
b. capping d. picking

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

a. drum roller c. planetary mixer
b. V-blender d. compactor mills

A 95. A roller mill is used to reduce the particle size of powders in:
a. ointment c. capsules
b. tablet d. emulsion

B 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 97. This part of the sugar coating process is to round off tablet contours rapidly:
a. sealing d. finishing
b. subcoating e. polishing
c. syruping

Problems: Primaquine Phosphate tablets, 30mg/tab

Formula mg/tab batch of 600,000 tabs
a. Primaquine PO4 30 98. 18kg

b. Lactose 56.6 99. 33.96kg

c. Starch 16.6 100. 9.96kg

d. PVP 0.57 101. 0.342kg

e. Stearic acid 0.23 102. 0.138kg

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103. Tablet weight = 104 mg

For nos. 104-108 Match by writing the equivalent capital letter of each ingredient corresponding to the role of each

C 104. Disintegrant

B 105. Filler

A 106. Active Ingredient

D 107. Binder

E 108. Lubricant

For nos. 108-111: After tablet compression, the 3 drums collected were weighed

Data Gross Tare Net

Drum 1 20kg 0.05kg 108. 19.95kg

Drum 2 21kg 0.06kg 109. 20.94kg

Drum 3 20.3kg 0.04kg 110. 20.26kg

111. 61.15kg

112. Compute for the actual number of tablets. Answer: 587,980 tablets

113. Determine the %wastage. Answer: 2.0%

B 114. Which of the ff additives in parenterals reduces the f\pain of injection in areas with nerve endings?
a. buffers c. synergist
b. tonicity adjusters d. chelating agents

B 115. Weight variation test is carried out iin:

a. 10 tabs c. 30 tabs
b. 20 tabs d. 40 tabs

A 116. The component present in the largest quantity in parenterals

a. vehicle c. buffers
c. solutes d. antimicrobials

A 117. The water resistance of glass containers is tested by

a. amount of alkali released into water c. changes in pH
b. amount of acid released into water d. none

D 118. The buffers commonly used in parenterals

a. citrates d. any of the choice
b. acetates e. none
c. phosphates

D 119. Granulation by compression is also known as

a. dry granulation c. double compression method
b. precompression method d. all of the above

A 120. Primary packaging components except

a. labels d. caps
b. bottles e. stoppers
c. tubes

C 121. The degree of freedom is used in calculation of

a. average c. standard deviation
b. mean d. range

A 122. To control microorganisms in the air is to

a. install UV lamps in several areas c. install IR bulbs in several areas
b. provide ETO gas around the room d. any of the above

D 123. The work “quality” SQC refers to characteristic of a product from:

a. quantitative c. identification

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b. qualitative d. a & b

C 124. The measure of the variation of individual observations around the average is:
a. range c. standard deviation
b. average d. any of the choices

B 125. Advantages of plastic containers over glass, except:

a. lightness in weight c. lower transportation
b. permeability d. resistance to impact

D 126. Indicator employed in sterilization process is

a. chemical wax or pellet c. biological suspension
b. colored paper strips d. any

B 127. In labeling of a product, an unlabeled portion is provided for

a. elegance c. save cost of labels
b. viewing the contents d. all of the above

D 128. Property of IV solutions

a. with aqueous vehicle c. hypotonic
b. isotonic d. a & b

C 129. The material present in both enteric and film coating

a. wax c. cellulose acetate phthalate
b. parafilm wax d. a &c

B 130. A lyophobic substance is easily wet by

a. polar solvents c. water
b. nonpolar solvents d. hydroalcohols

D 131. Characteristics of iirigation solutions to wash wounds and body cavitites may be
a. sterile c. with additives
b. pyrogen free d. a & b

B 132. Plastic material used for ophthalmic solutions as package and applicator is
a. polypropylene c.polystyrene
b. polyethylene d. PVC

C 133. A colloid mill is used for the ff, except:

a. reduce particle size of solids c. granulation
b. homogenize viscous emulsion d. produce finely divided solids

D 134. Use of buffers in parenterals

a. pH stabilizer c. tonicity contributor
b. sterilizer d. a and c

D 135. Foam in emulsion is prevented

a. apply compressed air c. add polyethylene
b. add antifoaming agent d. a and b

A 136. the dispensing division of the warehouse requires

a. licensed pharmacist c. experienced scientist
b. licensed chemist d. a & b

D 137. Room temperature recognized by USP is

a. 25ºC c. 20ºC
b. 10-30ºC d. temp at the working area

B 138. Uneven distribution of colors on the surface of tablets is

a. peeling c. capping
b. mottling d. lamination

D 139. The Board of Trustees of a company functions as the

a. protector of the company’s asset
b. prepare policies
c. active planning
d. a&b

D 140. To remedy the irritating effects of UV radiation is to

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a. wear UV goggles for eyes c. put off the UV light during operation
b. covers skin with clothing d. AOTA

A 141. The inspection and checking section of QC is responsible for

a. sampling of raw materials c. chemical assaying
b. testing sterility of products d. doing pyrogen test

A 142. The part of the transdermal drug delivery system patch where the drug is stored
a. reservoir c. back strips
b. peel strips d. membrane

B 143. Practical method of determining method of hardness is

a. Eureka Tester c. Pfizer Tester
b. Rule of Thumb d. Rosche Tester

A 144. Method of tablet manufacture for easily compressible or adhesive ing is

a. direct compression c. wet method
b. slugging d. a&b

B 145. Limulus amoebocyte lysate is obtained from

a. rabbits c. white mice
b. king crab d. microorganisms

D 146. The building used for manufacturing of pharmaceutical shall be of adequate space for
a. orderly placement of materials
b. prevent mix up of drugs and packaging matls
c. avoid risk of cross contamination of raw materials and label
d. AOTA

C 147. Stoke’s Monsanto tester is used to measure

a. thickness c. hardness
b. friability d. disintegration of tablets

D 148. Pharmaceutical aerosols may be in the form of

a. solutions c. emulsions
b. powders d. AOTA

A 149. Hemodialysis is employed to remove toxins from the

a. blood c. kidney
b. peritoneal cavity

B 150. Implantation pellets are those which contain

a. diluent c. lubricant
b. active ing d. disintegrant in their formation

D 151. Property of tablet granulations to obtain good tablets:

a. compressibility c. noramal distribution of fines
b. fluidity d. AOTA

B 152. In the manufacture of semisolid emulsions, the mixing of the oil and aqueous phases is done at the
temperature of:
a. 30-40ºC c. 80ºC
b. 70-72ºC d. NOTA

A 153. Hard gelatin capsules are also referred to as:

a. dry-filled capsules c. soft elastic
b. pork skin capsule d. SEC type

C 154. To identify pharm. Products that are registered in BFAD, the label consists of:
a. expiry date c. DR number
b. Bar marks d. category

D 155. Packaging and labeling operations are controlled to:

a. prevent mix ups b/w drugs and labels
b. assure that only those products that meet the standards are distributed
c. identify the finished products with a control number
d. AOTA

A 156. Quarantined materials delivered in the warehouse are:

a. subject to test and assay c. rejectable

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b. releasable to production dept. d. in-process products

B 157. Advantage of liquid medicines:

a. special techniques required for poorly soluble drugs
b. rapidly absorbed in the body
c. easy to manufacture
d. requires pharmaceutical elegance

D 158. Instability of drug substances in liquid form may be caused by:

a. variation in pH c. light of radiation
b. reduced temperature d. a&c

A 159. Disadvantage of glass material used in packaging of liquids is:

a. releases insoluble flakes upon storage
b. resistance to decomposition
c. oxide contents may be reduced
d. b & c

C 160. To increase viscosity of the aqueous phase of an emulsion is to:

a. add more emulsifier c. add dissolved macromolecules
b. active ing d. antibiotics

A 161. In suspension formulation, the suspension adjuvants may be

a. buffers c. drug substance
b. actives d. antibiotics

C 162. Suspending agents added to suspension formulations, except:

a. gelatin c. parabens
b. veegum d. methocel

A 163. In semisolid preparations, petrolatum is a common hydrocarbon base due to its:

a. consistency c. easily washed with water
b. hydrophilic character d a&b

D 164. Large volume parenterals are employed for:

a. maintenance therapy c. prophylactic therapy
b. replacement therapy d. a & b

B 165. Insoluble powders for ophthalmic preparations must be:

a. less than 200 microns in particle size
b. impalpable to the touch
c. pyrogen free
d. give preservative action

D 166. Dialysis solutions as life-saving preparations has the ff characteristics, except:

a. requires a semipermeable membrane to separate one substance from another
b. contains dextrose for supplies of calories
c. used for individuals with kidney failure
d. used to separate RBC from WBC

A 167. CGMP standards and regulations are enforced by BFAD for the purpose of:
a. assuring quality
b. assuring the protection from moisture
c. developing new product
d. assuring sales

B 168. The president of a company has the function of:

a. protecting the assets of the company
b. active planning and control of business
c. management of the major department
d. a and c

D 169. The phenomenon applied to adsorption at solid surfaces is:

a. wetting property c. flocculation
b. detergency d. a & b

D 170. Plastic containers are of advantage to manufacturers for us ein:

a. packaging of IV infusion

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b. ophthalmic solutions
c. place of Al metal to hold rubber stoppers in vials and bottles
d. a & b

D 171. A colloid is employed to:

a. reduce solid particle size of suspensions
b. homogenize viscous emulsions
c. produce finely divided solids
d. any of the above

A 172. Polyols may be added to cream formulation as:

a. humectant c. active ingredient
b. viscosity contributor d. a & b

C 173. Aspilet tablets for children are:

a. sublingual c. chewable
b. buccal d. soluble

C 174. An aerosol is a dispersion of:

a. solid in alcohol c. solid in gas
b. solid in water d. liquid in liquid

D 175. What is measured in dissolution test of a tablet?

a. extent of drug absorbed
b. rate of absorption of the drug substance
c. rate of drug eliminated
d. a & b

B 177. A type of ointment base known as creams is:

a. water soluble base c. hydrocarbon base
b. water removable base d. a & b

D 178. Complaint about a product may be:

a. adulteration c. high price
b. decomposition d. a & b

B 179. Pfizer tester that determines force to break a tablet is used to measure:
a. thickness c. friability
b. hardness d. disintegration

B 180. Transdermal delivery system is a sophisticated patch that delivers the drug from the skin:
a. GIT c. liver
b. bloodstream d. dermis

C 181. Implantation tablets are those which are administered:

a. orally c. insertion into body tissues
b. through vagina d. rectally

C 182. Accdg. to Stoke’s law, the sedimentation rate of suspension is directly proportional to:
a. viscosity c. particle size
b. density d. specific gravity

B 183. Improperly sealed ampules should be tested for:

a. particulate matter c. bacteria
b. leak d. pyrogen

TRUE OR FALSE. Write/ Mark A if the statement is correct and B if not.

A 184. Single containers may be in ampules, vials, or in large 250mL- 1000mL.

B 185. Tamper-proof seals are popular nowadays to allow easy pilferage of the contents.

B 186. Biologic products are stored at room temperature.

A 187. Buccal tablets are those which contain drugs to be absorbed thru the oral mucosa.

B 188. The 2 acids contained in effervescent tablets are citric acid and acetic acid.

B 189. LAL Test for pyrogens is interpreted by rise in temperature of rabbits.

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A 190. In ampule sealing, a tip sealing is characterized by a bead at the tip of the ampule.

A 191. One great advantage of pharmaceutical aerosols is that medication is dispensed in a ready-to-use form at
the push of a button.

A 192. For semisolid aerosol, the formulation is similar to other semisolid preparation but depends on nitrogen
gas to the contents from package.

B 193. Homogenization of an emulsion is done to uniformly disperse the insoluble solid drug in the vehicle.

B 194. In the manufacture of emulsified semisolid, the mixing of the phases is done at a temperature of 43-45ºC
for intimate blending.

A 195. Hydrocarbon waxes are added to semisolid formulations to increase the viscosity of mineral oil and
prevents separation.

B 196. The natural emulsifiers like acacia form a colloidal layer to prevent coalescence of droplets.

B 197. Creaming in emulsions is the separation of emulsified droplets which are denser that settle at the
container.

B 198. The DDB is under the jurisdiction of the BFAD.

A 199. Spray drying technique can produce finely divided particles for suspension formulation.

B 200. Flint glass refers to the amber colored glasses used to protect from light.

A 201. The production control department of the plant division is in charge of inventory.

B 202. The approved for use materials are labeled with red color.

B 203. The medical department of a manufacturing establishment is in charge of:

a. plant & employee safety c. both a & b
b. house organ publication d. none

D 204. Facilities needed for pharmaceutical research:

a. library c. animal house
b. pilot plant d. all

A 205. The production department of a pharmaceutical manufacturing establishment is in charge of, except:
a. production personnel control
b. labeling & other packaging materials
c. inventory control
d. in-process analysis

C 206. One of the ff. is not a QC function:

a. inspection of container
b. labeling & other packaging material
c. inventory control
d. in process analysis

A 207. Documentation is the main responsibility of:

a. central release office
b. checking & investigation section
c. purchasing department
d. sales, promotion and merchandising department

C 208. It means any establishment engaged in operations involved in the production of drugs including
propagation, processing, compounding, finishing, filling, packing, repacking, and labeling in view of
storage distribution or sale of the product:
a. drug distributor c. drug manufacturer
b. drug trader d. none of the above

C 209. Statement of expiration date assure of:

a. absence of interaction c. full therapeutic efficacy
b. absence of toxicity d. recovers from ailment

B 210. The expiration date of paracetamol tablet states “January 1999”. This statement means that, by January
1999, the product will have lost its activity:
a. less than 90%

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b. sufficient activity to be outside the USP monograph requirement

c. meet BFAD requirement
d. comply with DOH requirement

A 211. The barcodes imprinted in labels of products serve to:

a. distinguish one product from another
b. impart elegance
c. meet BFAD requirement
d. comply with DOH requirement

A 212. These are quality assurance functions, except:

a. product forecasting
b. auditing, and control of all manufacturing documents before and after production
c. CGMP monitoring
d. environmental control

A 213. One of the ff. situations can avoid cross contamination and mix-ups:
a. components are tightly sealed
b. improper partitioning of working areas
c. components are improperly dispersed
d. wrong label

B 214. The manufacturing batch record should contain the ff. information, except:
a. in-process test, finished product QC test results
b. general manager’s signature
c. manufacturing procedures
d. dispensing batch number quantitative and qualitative formula

B 215. The QA inspectors usually inspect and audit warehouse CGMP’s :

a. stock rotation (FIFO)
b. all of these answers
c. separation of materials, quarantine, approved, rejected
d. protection of material from cross contamination

B 216. If a bottle of tablets has an expiration date of January 1999, the pharmacist may,
a. dispense the tablets only until January 1, 1999
b. dispense the tablets only until January 31, 1999
c. dispense the tablets only until January 15, 1999
d. continue to dispense the product if he has already opened the container

A 217. Reaction kinetics study can help predict the:

a. shelf life c. toxicity
b. effectivity of a formulation d. potency

D 218. In the CGMP, we usually consider the:

a. building c. equipment
b. personnel d. all

C 219. Any substance of a drug product intended to furnish pharmacologic effect is:
a. excipient c. actives
b. drug substance d. b & c

C 220. The concept where raw materials are purchased only at a time when it is needed and at a quantity
enough to carry out a single production
a. FIFO c. cost cutting
b. preformulation purchasing d. just-in-time

D 221. Soda Lime glass is also known as:

a. Type I c Type III
b. NP d. b &c

B 222. Container impervious to air:

a. tight container c. closed container
b. hermetic container d. single dose container

B 223. If you are QC inspector, what critical defect if found should stop the packaging operation and could be
processed if results of investigation are satisfactory:
a. inverted label c. smeared label
b. wrong label d. misaligned label

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A 224. Highly resistant borosilicate glass is also known as:

a. Type I c. Type III
b. Type II d. NP

A 225. It refers to the statement regarding the conditions, wherein the use of the product may cause harm to the
patient:
a. contraindication c. precaution
b. caution d. all of the above

C 226. Type of container that protects the content from extraneous solids, liquids, or vapors from loss of the
drug:
a. hermetic c. tight
b. well-closed d. light resistant

B 227. Single unit container include the ff., except:

a. sachets c. strip packages
b. collapsible tubes d. blister packs

C 228. It refers to the instruction and special care required in the use of the product to avoid undesired effects
and to ensure the safe and effective use of the drug:
a. caution c. precaution
b. contraindication d. all of the above

B 229. Component of closure that inserted in a cap to effect a hermetic seal between the closure and the
container
a. cap c. inner seal
b. liner d stopper

D 230. Common component of cap liners, stoppers and parts of dropper assembles:
a. metal c. plastic
c. glass d. rubber
D 231. One of the ff. is not an advantage of plastic over glass containers:
a. lightness in weight c. lower transportation cost
b. resistance to impact d. permeability

C 232. The all glass container for small volume parenterals:

a. vacoliter c. ampule
b. vials d. b & c

B 234. Tamper-resistant package except:

a. breakable caps c. bubble packs
b. liner d film wrappers

B 235. Material of plastic containers that can be remelted and reprocessed, except:
a. polystyrene c. polypropylene
b. melamine formaldehyde d acrylics

B 236. The product inserts fro many drug products contain statements. Which of the ff. sequences lists the 3 type
of caution in the order of least to most serious?
a. contraindication, precaution, warning
b. precaution, warning, contraindication
c. warning, contraindication, precaution
d. contraindication, warning, precaution

C 237. Advantages of glass containers, except:

a. inertness c. resistance to impact
b. rigidity d visibility

B 238. Package component used to prevent during shipping including cotton, rayon and polyester
a. inner weal c. liner
b. coil d. dessicant

C 239. Primary packaging materials, except:

a. bottles c. labels
b. capsules d. caps

C 240. Release or movement of the components of the container into the contents:
a. sorption c. leaching
b. breathing d. porosity

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D 241. Function of a package include:

a. for convenience c. for protection of content
b. for legal compliance d. all of the answers

A 242. Multiple dose containers include:

a. vials c. ampules
b. cartridges d pre-filled syringe

D 243. Functions of a package include:

a. to provide presentation c. for communication
b. to provide containment d. all of the above

B 244. Accdg. to USP standard, freezer or refrigerator can be used to store pharmaceuticals that specify storage
in a :
a. cool place c. dark place
b. cold place d controlled room temperature

C 245. Accdg. to the USP monograph instruction, protect from light indicates storage in:
a. dark place c. light resistant container
b. flint glass d. tight glass container

A 246. To assign in assuring the stability of a dosage form during transport and storage, the label shall indicate:
a. storage condition c. concentration of the drug
b. expiry date d. any of the above

C 247. The term soluble refers to part s of solvent that can dissolve 1 part of solute is:
a. 1-10 c. 10-30
b. 30-100 d. less than 1

B 248. The temperature of a cool place is:

a. not more than 8ºC c. 15-30ºC
b. 8-15ºC d. 25ºC

C 249. When 1 part of the solute dissolves in 1-10 parts of solvent, it is:
a. very soluble c. freely soluble
b. soluble d. sparingly soluble

C 250. The usual storage condition specified for biologicals is:

a. room temperature c. 2-8ºC
b. below 2ºC d. a cool place

A 251. Type of mill which makes use of compressed gas to cause turbulence inside the chamber.
a. fluid energy mill c. colloid mill
b. ball mill d. hammer mill

A 252. The ff. are preservatives used in dosage forms, except:

a. PG c. methylparaben
b. propylparaben d. Na benzoate

A 253. Filtration process wherein the liquid passes thru one filter pad or disc:
a. parallel c. a & b
b. series d none of the above

D 254. Factors that accelerate instability include:

a. temperature c. moisture
b. light d. all of the above

C 255. The composition of oral rehydration are:

a. amino acid, glucose, water
b. glucose, Na, K, HCO3, water
c. glucose, Na, K, Cl
d. citric acid, glucose, Ca, water

C 256. The generally accepted liquid product artificial sweetener:

a. cyclamate c. saccharin
b. glutamate d. glucose

C 257. Veegum is a/an:

a. organic gum c. clay
b. synthetic gum d. nonionic surfactant

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A 258. Type of resin that is used to deionize water:

a. synthetic c. prepared
b. resins d. natural

B 259. Buffers are used:

a. to bring about the solubility of insoluble substance
b. to maintain pH pf solution thus attaining maximum stability
c. as preservative
d. none of the answers

B 260. A finished product where sterility is not at its maximum observance:

a. ophthalmic c. theobroma oil
b. otic d. emulsified theobroma oil

B 261. 28% of an anti-pruritic preparation is composed of 3 active ingredients in ratio of 7:5:4. If marketing
requires 190kg batch size, determine the required amount of active ingredients:
a. 61.3kg c. 98.5kg
b. 53.2 kg d. 11.9kg

A 262. An eardrop preparation requires 0.017g of the active per 15 ml bottle presentation. If production calls for
1500 L batch size, determine the theoretical amount of the active needed.
a. 10.70 kg c. 23.70 kg
b. 16.05 kg d. 160.5 kg

C 263. Pressure operated filling set up is used for liquid which are
a. free flowing c. viscous
b. all of these d. foaming

D 264. A typical erythema score of 2 in the irritation test for ointment means
a. no visible reaction
b. intense erythema with edema
c. mild erythema
d. intense erythema
e. intense erythema with edema and vesicular erosion

B 265. Anhydrous lanolin has the ff property

a. water absorbing ability is less c. pleasant odor
b. more stable and free from rancidity d. non sticky consistency

A 266. Penetrometers are used to measure consistency and viscosity of

a. ointments c. micelles
b. suspensions d. thixotropic materials

C 267. Mixing equipment for solid materials except

a. sigma blade mixer c. Fitz Patrick Chilsonator
b. Ribbon blender d. Twin shell V blender

D 268. Solid dosage forms are more advantageous than liquid forms because of the ff reasons, except:
a. can be easily dispensed c. not prone to bacterial contamination
b. stability d. method of manufacture is easier

B/C 269. Granular forms are important because they

a. prevent segregation of powders c. are easier to wet
b. are more stable d. all of the above

C 270. A parvule is
a. bolus c. granule
b. wafer d. large pill

B 271. Materials added to provide cohesion in components for compression

a. lubricant c. fillers
b. binder d. disintegrant

B 272. Molded lozenges are referred to as:

a. Troches c. Extracts
b. Pastilles d. Film tab

B 273. Content uniformity tests is to be performed for all tablet products whose active ingredient is:

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a. 130 mg or less c. 324 mg

b. 50 mg or less d. 50 mg or more

D 274. Starch, povidone, Mg Stearate, and lactose added to Aspirin tablets are
a. actives c. vehicles
b. Inerts d. additives

A 275. For the disintegration test for enteric coated tablets, the immersion fluid is:
a. Simulated Gastric fluid TS c. water
b. oil d. PO4 buffer

A 276. The method for the preparation of compressed tablets wherein the granulation is formed by compacting
large masses of the mixture and subsequently crushing and sizing these pieces into smaller granules
a. dry granulation method c. direct compression method
b. wet granulation method d. all of the above

C 277. Aside from fluidity, powders for compression must possess

a. flowability c. compressibility
b. adhesiveness d. all of the above

B 278. Drugs that are available as sustained release dosage forms utilizing ion exchange resins include:
a. spansule c. gradumet
b. ionamine d. all of the above

A 279. Film coating problem due to internal stress

a. cracking c. mottling
b. lamination d. orange peel or roughness

C 280. The disintegration medium for plain uncoated tablet is:

a. Simulated Gastric Fluid TS c.DistilledWater
b. Simulated Intestinal Fluid TS d. a & c

B 281. The most commonly used of determining the particle size of powders and granules is:
a. coulter counter c. microscopy
b. sieve method d. none

D 282. The ff are binders, except

a. starch c. bentonite
b. acacia d. Cab-O-sil

B 283. Content uniformity is used to ensure which of the ff qualities in tablet products
a. disintegration c. purity
b. potency d. toxicity

B 284. For rapid disintegration of compressed tablet, this range of concentration of starch is recommended:

a. 5% c. 15-20%
b. 10-15% d. 20-25%

C 285. Rule of thumb is used for testing

a. ampules c. compressed tablets
b. hypodermic tablets d. vials

C 286. A tablet formulation calls for 2 active ingredients which are chemically incompatible. The best method to
be used is:
a. dry granulation c. double layered tablets
b. wet granulation d. spray drying

B 287. Poorly manufactured tablets may have small pinholes on the surface, this defect is called:
a. mottling c. capping
b. picking d. compacting

D 288. In the preparation of effervescent tablet, the most important ingredients necessary to give the
effervescent effects are:
a. NaHCO3 and Citric acid c. Na2CO3 and Tartaric acid
b. Citric acid and Tartaric acid d. a & c

A 289. Common binder used in tablets

a. gelatin solution c. liquid petrolatum
b. lycopodium powder d. lactose

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C 290. The theoretical weight of ten 10 tabs is 9.35 grams. Each tablet contains 425 mg of the active. Using this
data, determine the amount of additive needed to prepare 160,000 tablets.
a. 51.0 kg c. 81.6 kg
b. 102.5 kg d. 149.6 kg

D 291. Separation of a tablet into 2 or more distinct layers

a. mottling c. speculation
b. granulation d. lamination

C 292.Part of a tablet machine which controls the size and shape of the tablet is
a. punches c. die
b. hopper d. cam

C 293. Formulation methods of achieving sustained drug release include

a. use of coating c. all of these answers
b. microencapsulation d. embedding the drug in matrix

B 294. The method of tablet manufacture for easily compressible or adhesive ingredient is:
a. dry granulation c. slugging
b. direct compression d. wet method

B 295. One of the ff does not apply to uses of colloid mills

a. homogenize viscous emulsions c. produce finely divided solids
b. granulate d. reduce particle size of solids

A 296. One of the ff substances is not used as lubricant in tablet manufacture

a. starch c. Mg stearate
b. talc d. Ca Stearate

C 297. One of the ff is not an advantage of multi layered tablets

a. maybe coated tablet
b 2 incompatible drugs may be kept separated
c. accurate control of the delayed action part
d. each layer has a separate color for identity

D 298. The ability of the tablet to withstand abrasion in packaging, handling and shipping is evaluated by its:
a. content uniformity c. hardness
b. dissolution test d. friability

D 299. This is a common lubricant for tablets:

a. mannitol c. starch
b. acacia d. Mg stearate

D 300. Which of the ff is/ are used in tablet formulation to reduce friction during tablet compression?

(1) Calcium stearate

(2) Mg stearate
(3) Stearic acid

a. none of these answers c. 1 and 2

b. 1 and 3 d. 1, 2 and 3

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