1.

________ test is used to test the package integrity

a. clarity test
b. leakage test
c. sterility test
d. melting range test

2. which culture media is used for sterility test

a. agar
b. blood agar
c. fluid thioglycate medium
d. none of these

3. which one of the following are the characterictics of dye bath method
a. a)qualitative,slow,destructive
b. b)quantitative,rapid,non destrucive
c. c)proceeds at a moderate speed
d. d)none of these

[Link] vapour permiability test is checked at

a)16-20degree

b)10-12degree

c)20-30degree

d)20-25degree

5.________ are the factors of importance in sterility test

a)environment

b)quality of culture

c)both a&b

d)none of these

6.a suppository may act as a__________

a)suspension

b)palliative

c)sublingual

d)oral

[Link] blooming of suppositories occurs due to

a)pressure

b)temperature

c)environment

d)other physical effects

[Link] result of mechanical strenght test occurs at temp______pressure.

a)1.8-2kg

b)3-4kg

c)4-5kg

d)5-6kg

[Link] range test is done in

a) glass beaker

b)petri dish

c)usp tablet disintegration appratus

d)none of these

[Link] meters are verified with standard certified______ solutions before use

a)acidic solutions
b)basic solutions

c)both a&b

d)buffer solution

1. pH meter are verified with standard certified

a) H2SO4
b) Buffer solution
c) Tyrode solution
d) HCl solution

2. A substance used to furnish pharmacological activity is:

a) Binder
b) API
c) Lubricant
d) All of these

3. The undesired introduction of impurities into or on to a starting material is

a) Contamination
b) Cross contamination
c) Adultration
d) None of these

4. Fissuring of suppositories means:

a) Denting
b) Breaking
c) Melting
d) Hardening

5. Comparison between theoratical quantity and actual quantity is:

a) Quality assurance
b) Reconcilliation
c) Qualification
d) Caliberation

6. leakage test is performed to check the:

a. Tablet integrity
b. Suppositories
c. Package integrity
 d. Lotions

7. bacterial endotoxins are assayed in the:

a. Dye bath test

b. Sterility test
c. LAL TEST
d. None of these

8. Rough and irregular surface of particles gives:

a. Lower angle of repose

b. Higher angle of repose
c. Moderate angle of repose
d. No any effect

9. Greater the powder density hausner ratio will be

a. Greater
b. Zero
c. Negative
d. Lesser

10. Major factors of importance in sterility testing:

a. The environment
b. Test method
c. The sample size
d. All of these

11. Golden yellow flame will indicate the presence of:

a. Sodium salt of benzoic acid

b. Potassium salt of benzoic acid
c. Calcium salt of benzoic acid
d. Sodium salt of bicarbonates

12. white precipitates indicates the presence of:

a. Aliphatic ring
b. Aromatic ring
c. Both
d. None of these

13. oxalic acid in cold water is:

a. Sparingly soluble
b. Insoluble
c. Soluble
d. Freely soluble
14. percentage deviation of tablet diameter is:

a. ±13%
b. ±5%
c. ±12%
d. None

15. what is the limit of tablets that can deviate second range:

a. 3
b. 2
c. 1
d. 0

1. Membrane filters having normal pore size not greater than:

a) 0.2um
b) 0.3um
c) 0.4um
d) 0.5um

2. Contamination of a starting material,intermediate product or finished

product with another starting material or product during production:

a) cross contamination
b) Batch number
c) finished product
d) in process control

3. Unit of measuring hardness is:

a) kg/cm2
b) 5 to 10 kg/cm2
c) 2 to 10 kg/cm2
d) 3 to 10 kg/cm2
4. Breaking force of tablets is commonly called ;
a) Hardness in the pharmaceutical literature
b) Resistance of tablets
c) amount of binder
d) both a & c
5. Pessaries are a type of suppository intended for;

a) vaginal use
b) sublingual
c) buccal
d) oral

6. No of container used for the test as per to bp,usp,Ep for <3ml

a)1
b)2
C)5

7. Inplants are sterile solid preparations of size and shape for implantation
into..
a)Epithelial
b)Body
c)Muscular
d)connective

8. leakage test is used to check the:

a)Integrity
b)sterility
c)particulate matter
d)ampoules

9. FTM is a excellent medium for the detection of bacterial contamination:

a)Aerobic
b)Anaerobic
c)Both a and b
d)None of them

[Link] evaluates the tablet ability to withstand the _in

packaging,handling and shipping..
a)Hardness
B)Abbration
c)Weight
d)Time

[Link] of oxalic acid is:

a)1.6g/cm3
b)1.8g/cm3
c)1.9g/cm3
d)1.7g/cm3

[Link] do we measure hardness:

a) determine the need for pressure adjustment on tableting machine

b) hardness can affect the disintegration
c) both a & b
d) none

[Link] operations of purchase of materials and products,production quality

control,release ,storage is :

a) Manufacture
b) Batch number
c) finished product
d) in process control

14. Yellow area is present in:

a) Qurantine
b) reconcilation
c) master record
d) Production
 [Link] characteristics of suppositories is ;
a) cut longitudinal
b) fissuring
c) pitting
d) All

Select the correct option in the given options:

1. Fungi is incubated at ------ for not less than------
a) 30 to 35° C for 14 days c) 25 to 30°C for 7 days
b) 20 to 25°C for 7 days d) 20 to 25°C for 14 days
2. Dye bath test in parenteral can optimized by use of
a) Binder c) Surfactant
b) Preservatives d) None of them
3. Good Manufacturing Practice is that part of
a) Quality Assurance c) IPQC
b) Quality Control d) Both a and b
4. Citric acid brand name is
a) ENO lemon c) Gripe water
b) Acid citriqual d) Both a and b
5. Density of benzoic acid is
a) 2.265 g/cm³ c) 1.456 g/cm³
b) 3.452 g/cm³ d) 1.265 g/cm³
c) 1. A finished dosage form that has undergone all stages of manufacture,including packaging in
its final container and labelling is called?
d) a) Bulk product
e) b) Finished product
f) c) Pharmaceutical product
g) d) B and C
h) 2. Apparatus usually have two platens between which tablets is placed?
i) a) Monsanto hardness tester
j) b) Pfizer hardness tester
k) c) Heber lain hardness tester
l) d) Strong cob tester
m) 3. The result of strong cob hardness tester is ………… accurate than Heberlain hardness tester?
n) a) 1.4 times
o) b) 1.5 times
p) c) 1.6 times
q) d) 1.7 times
r) 4. The result of strong cob hardness tester is ………… accurate than Pfizer hardness tester?
s) a) 1.4 times
t) b) 1.5 times
u) c) 1.6 times
v) d) 1.7 times
w) 5. A document or a set of documents that serve a basis for the batch documentation?
x) a)qualification
y) b)validation
z) c)master formula
aa) d)none
bb)
cc)
dd) Sterility is required for
a) Tablet b) capsule
c) *injectable* d) topical creams

Weight variation test is done for the

a) tablet
b) capsule
c) suspension
d) *all of these*

Bulk and tap density is done for the

a) *granules*
b) tablet
c) capsule
d) none of these

100% bioavailability is given by ....... route

a) *parental*
b) oral
c) topical
 d) all of these

Pyrogen test is done for

a) *parental*
b) topical
c) oral
d) all of these

Dissolution of Enteric coated tablet is occur in

a) stomach
b) buccal cavity
c) *intestine*
d) none of these

Content uniformity is necessary for

a) tablet
b) capsule
c) ointment
d) *all of these*

Tablet production is done according to the

a) *GMP*
b) SOP
c) both of these
d) none of them

A solid dosage form intended to be inserted into various body orifices where they melt, dissolve,
or disperse to exert local or systemic effects is called
a) *suppository*
b) tablet
c) capsule
d) none of these

If hardness of tablet increases, rate of dissolution

a) *decreases*
b) increases
c) independent
d) none of these

e) Blank batch Record is also known as:

e) Master Formula
f) Master Record
g) Batch Record
h) None of these
2. Hardness is also called as

e) Crushing test
f) Weighing test
g) Both a and b
h) None of these

3. Unit of measuring hardness is

e) cm3
f) Kg
g) Kg/cm2
h) Kg/cm3

4. Time of disintegration of buccal tablets is

e) 6 hours
f) 4.5 hours
g) 4 hours
h) 3 hours

5. Suppositories available for vaginal use are called as

 Nasal cones
 Bougies
 Pessaries
 None of these

6. Suppositries are

 Single dose
 double dose
 both of them
 None

7. For physical test of suppositries

 cut longitudinally
 cut in oposite direction
 Cut in centre
 none

8. suppositories inserted in nose

 .bougies
 .cones
 .Pessaries
  All of them

9. Suppositries inserted in ear

 bougies
 .cones
 pessaries
 .none

10. Good result for mechanical strength test.

 1.8_2kg pressure
 .2.1_3
 .5_6
 7_9

11.A document or set of document that serves as a basis for batch documentation called

 Master record
 Batch record
 BAtch number
 all

12. Basket rack assembly consists of -transparent tubes

 6open ended
 3 open ended
 .4open ended
 5open ended

13. In mechanical strength,how much time is needed to break suppositories during test?

 .1minute
 2minutes
 3minute
 4 minute

14. Pressure applied on suppositories for crushing test

 1.8 to 2 kg
 2 to 3.8 kg
 4 to 5 kg
 3 to 6 kg

15. In content uniformity test, RSD is less than or equals to

 5%
 6%
  7%
 8%

16. A product with all processing stages except final packaging is

 Finished product
 Bulk product
 Batch
 Pharmaceutical product

17. .Citric acid is ______ in cold water

 .soluble
 Insoluble
 .partially soluble
 Sparingly soluble

18. which test is not included in physical tests of tablets?

 .weight variation
 Friability
 *content uniformity*
 Thickness

19. In friabilator,.the drum rotates over

 24 RPM
 . *25RPM*
 26RPM
 27 RPM

20. In friabilator, the drum rotates for

 2 min
 3 min
 *4 min*
 5 min

21. Percentage friability should b less then

 100%
 10%
 . *1%*
 None

1. Factors affecting growth of Bacteria

 (a) Air
(b) PH
(c) Light
(d) All of these

2. The dye test can be optimized by use of

(a) Surfactant
(b) Low viscosity fluid
(c) High viscosity fluid
(d) Both a and b

3. Suppositories are also available to be inserted in nose, known as

(a) Nasal cones

(b) Nasal bougies
(c) Ear cones
(d) None of these

4. Pessaries are a type of suppositories intended for

(a) Rectal use

(b) Vaginal use
(c) Transdermal use
(d) None of these

5. In suppositories change in odor may be indication of a

(a) Degradation process

(b) Discoloration process
(c) Contamination process
(d) All of these

1. Factors affecting the hardness

(a) Compressive force

(b) Amount of Disintegrant
(c) Amount of Binder
(d) Both a and c

2. Which Method give the best Hardness?

(a) Wet method

(b) Dry method
(c) Slugging Method
(d) All of these

3. Suppositories are also available to be inserted in ear, known as

 (a) Ear bougies
(b) Ear cones
(c) Nasal bougies
(d) None of these

4. Hardness is also known as

(a) Crushing strength

(b) Binding strength
(c) Disintegrating strength
(d) None of these

5. Suppositories act as carrier agent for

(a) Local action

(b) Systemic action
(c) Both a and b
(d) None of these

1. A material intended for human and veternary use after finishing is:

f) API
g) Pharmaceutical product
h) Intermediate product
i) All of these
2. The max. Range of 1 suppository out of 30 is:

i) 85%-115%
j) 75%-125%
k) 7.8%
l) Both B & C
3. Suppositories are adapted for introduction in:

i) Rectal
j) Vaginal
k) Urethral
l) All
4. Balances are to be checked__________ using internal caliberation

 Weekly
 Monthly
 Daily
 Yearly
5. Most commonly used hardness apparatus is:
 Stokes hardness tester
 Pfizer tester
 Strong cob
 Heberlain tester

6 Which injections are intended for administration only after Dilution….:

a) Powder for infusion
b) Concentrated solutions for injections
c) powder for injections
d) all of above
7 Implants are used for:
a) To place a missing biological structure
b) To avoid contamination
c) To avoid integrity
d) None of above
8 The transparent particles observed against the black background in …. Test:
a) Leakage test
b) Clarity test
c) Dye bath test
d) A and C both
9 Rough and irregular surface of particle gives:
a) Lower angle of repose
b) Moderate angle of repose
c) Higher angle of repose
d) No any effect
10 FMT is an medium for the detection of:
a) Bacterial contamination
b) Viral contamination
c) Fungal contamination
d) Any contamination
11 Benzoic acid is soluble in:
a) Warm water
b) Acetone
c) Both of above
d) None of above
12 Evolution of CO2 indicates the presence of:
a) Ketones
b) Benzoic acid
c) Carboxylic acid
d) All of above
13 White precipitates indicates the presence of:
a) Benzoic acid
b) Oxalic acid
 c) Carboxylic acid
d) Tartaric acid
14 What is the limit of tablets that can deviate Second range:
a) 1
b) 2
c) 3
d) 4
15 Formation of Yellow precipitates indicates:
a) Aromatic ring
b) Aliphatic ring
c) Carboxylic acid
d) None of these

1. Controlling the procedures involved in manufacturing of the dosage forms starting from raw
materials purchase to dispatch of the quality product in ideal packaging is:
(a) QC (c) QA
(b) IPQC (d) IPQA
2. Freedom from the presence of viable microorganisms:
(a) Sterility Test (c) Cleaning Test
(b) Clarity Test (d) Particulate Matter Test
3. All of the following factors affect the growth of the bacteria except?
(a) Moisture (c) Sample size
(b) pH (d) Light
4. Sterility test methods are:
(a) Direct inoculation method (c) Incubation method
(b)Membrane filtration method (d) Both (a) & (b)
5. Temperature for incubation of fungi is:
(a) 20-25 c for less than 7 days (c) 20-25 c for 7 days
(b) 30-35 for less than 7 days (d) None
6. Powdered glass test is performed for:
(a) Incubation (c) Packaging containers
(b) Plastics (d) Sterility
7. LAL test is also called:
(a) Clarity test (c) Sterility test
(b) Pyrogen Test (d) Leakage test
8. Maximum pore size for membrane filter is:
(a) 0.5 mcm (c) 0.6 mcm
(b) 0.7mcm (d) 0.4mcm
9. Test sample is added directly into the required media, ensuring that the amount of sample is
below:
(a) 20% (c) 30%
(b) 10% (d) 5%
10. Which of the following test is used to detect the presence of bacterial endotoxins in drugs and
biological products:
(a) Pyrogen test (c) Both (a) & (b)
(b) LAL test (d) None

1. Suppository is considered disintegrated when:

a) Completely dissolved
b) Dispersed into its component parts
c) Become soft
d) All of these

2. Any product that has completed all processing stages up to but not
including,final packaging:

a) Bulk product
b) Batch number
c) finished product
d) in process control

3. Tablet hardness should lie between:

a) kg/cm2
b) 5 to 10 kg/cm2
 c) 2 to 10 kg/cm2
d) 3 to 10 kg/cm2

4. Which method give the best hardness

a) granulation
b) slugging
c) lagging
d) wet granulation
5. Apply the test for uncoated [Link] 4 hours lift basket & observe the
tablets all the tablets isintegrated these are;

a) sublingual tablets
b) Delayed release tablets
c) buccal tablets
d) plain coated tablets

1. The volume of small volume parenterals is _ ml.

a) <100
b) <200
c) <300
d) <400

2. The functional group test for Benzoic acid resulting in evolution of CO2 indicates that it has
a) Hydroxide group
b) Methyl group
c) Carboxylic group
d) Ester group

3. Formation of white precipitate in aromatic ring test indicates

a) Aromatic ring is present
b) Aromatic ring is absent
c) Carboxylic acid is present
d) Carboxylic acid is absent

4. Evolution of CO2 in functional group test indicates the presence of

a) Carboxylic acid
b) Sulphuric acid
c) Benzoic acid
d) Ester

5. Culture media used for sterility testing

a) Fluid Thioglycolate medium
b) Agar medium
c) Soybean casein digest medium
d) Both a and c

e) A comparison between the theretical quantity and the actual quantity is:

a) Reconciliation
b) quarantine
c) quality unit
d) All of these

f) Any product that has completed all processing stages up to but not
including,final packaging:

a) Bulk product
b) Batch number
c) finished product
d) in process control

g) Unit of measuring hardness is:

a) kg/cm2
b) 5 to 10 kg/cm2
c) 2 to 10 kg/cm2
d) 3 to 10 kg/cm2

h) Factors affecting the hardness;

a) compression of tablet
b) slugging
c) amount of binder
d) both a & c
i) Apply the test for uncoated tablets operating the apparatus for the time
specified in the individual monograph these are;

a) sublingual tablets
b) Delayed release tablets
c) buccal tablets
d) plain coated tablets

1. Citric acid is ____ in cold water:

a. Soluble
b. Insoluble
c. Sparingly soluble
d. None of the above

2. The presence of citric acid in a residue is indicated by _____ color of flame:

a. Golden yellow
b. Purple
c. Maginda blue
d. Aqua blue

3. Benzoic acid is _____ in cold water:

a. Sparingly soluble
b. Insoluble
c. Sparingly soluble
d. None of the above

4. The evolution of CO2 from a sample may indicate one of the following:
a. Carboxylic acid presence
b. Presence of mercury
c. Presence of carbonado
d. Presence of Guerlain

5. Yellow colored tape usually represents objects which might be _____

a. Used
b. Already used
c. Rejected material
d. None of the above
1. A material intended for human and veternary use after finishing is:
a) API
b) Pharmaceutical product
c) Intermediate product
d) All of these
 2. The max. Range of 1 suppository out of 30 is:
a) 85%-115%
b) 75%-125%
c) 7.8%
d) Both B & C
3. Suppositories are adapted for introduction in:
a) Rectal
b) Vaginal
c) Urethral
d) All
4. Balances are to be checked__________ using internal caliberation
a) Weekly
b) Monthly
c) Daily
d) Yearly
5. Most commonly used hardness apparatus is:
a) Stokes hardness tester
b) Pfizer tester
c) Strong cob
d) Heberlain tester
6. Why do we measure hardness:
a) determine the need for pressure adjustment on tableting
machine
b) hardness can affect the disintegration
c) both a & b
d) none

7. All operations of purchase of materials and products,production quality

control,release ,storage is :

a) Manufacture
b) Batch number
c) finished product
d) in process control

8. Yellow area is present in:

a) Qurantine
b) reconcilation
c) master record
d) Production

9. Physical characteristics of suppositories is ;

 a) cut longitudinal
b) fissuring
c) pitting
d) All
Pessaries are a type of suppository intended for;
a) vaginal use b) rectal c) stomach d) Urethral
1. A suppository may act as a_________ or _________ to the local tissues.
a) Protectant
b) Palliative
c) Carrier of therapeutic agents
d) All of these
2. Which are the tests performed for suppositories?
a) Melting range test
b) Mechanical strength/crushing test
c) Content uniformity testing
d) All of these
3. The RSD of the 30 dosage units does not exceed_____%.
a) 8.9
b) 7.8
c) 8.7
d) 9.8
4. pH meters are verified with standard certified _____________ before use.
a) Normal saline
b) Buffer solution
c) Acetone
d) Chloroform
5. Records should be kept of each item of equipment, instrument or other
device used to perform________________
a) Calibration
b) Testing
c) Verification
d) All of these
6. The ____________________ of the products minimizes any risk to their
quality.
a) Proper storage
b) Instructions
c) Distribution
d) Both a and c
7. Any substance or mixture of substances intended to be used in the
manufacture of a pharmaceutical dosage form and when used, act as
active ingredient of that pharmaceutical dosage form:
a) Excipient
b) API
c) Drug
d) None of these
8. A document or set of documents that serve as a basis for the batch
documentation:
a) Master formula
b) Master record
c) Manufacture
d) Consignment
9. Action of proving that any premises, systems and items of equipment
work correctly and actually lead to the expected results.
a) Validation
b) Qualification
c) Packaging
d) Intermediate product
10. The status of starting or packaging materials, intermediates, or
finished products isolated physically or by other effective means:
a) Reprocessing
b) Standard operating procedure(SOP)
c) Specification
d) Quarantine
11. Reconciliation is a comparison between ______ and ______.
a) Theoretical quantity
b) Actual quantity
c) Both a and b
d) None of these
12. Validation is the action of proving in accordance with the
principles of _____:
a) GMP
b) GLP
c) GCP
d) Both b and c
13. A distinctive combination of numbers or letters which identifies a
batch on the labels, its batch records etc.
a) Batch record
b) Batch number
c) Batch
d) Finished product
14. Any product that has completed all processing stages up to not
including final packaging is called:
a) Lot number
b) Bulk product
c) Finished product
d) Batch
15. The undesired introduction of impurities of a chemical or
microbiological natureor of foreign matter in any of the processes:
a) Cross contamination
b) Contamination
c) Self-contained area
d) Both a and b
e) Hardness is also called?
 Agil strength
Maximum strength
Crushing strength
Relative strength
f) At which temperature a U-tube is partially immersed in a
constant temperature bath?

25 -35c
35-37c
40-42c
40-46c
g) Pessaries are a type of suppository intended for?

Rectal use
Uratheral use
Vaginal use
Nose use
h) An operation in the manufacturing process that may cause
variation in the quality of the pharmaceutical product are called?

Contamination
Cross contamination
In process control
Critical operation
i) A comparison between the theoretical quantity and the actual
quantity is known as?

Recovery
Reconcilination
Reprocessing
Reworking
1. pH meter are verified with standard certified
e) H2SO4
f) Buffer solution
g) Tyrode solution
h) HCl solution
2. A substance used to furnish pharmacological activity is:
j) Binder
k) API
l) Lubricant
m) All of these
3. The undesired introduction of impurities into or on to a starting material is
e) Contamination
 f) Cross contamination
g) Adultration
h) None of these
4. Fissuring of suppositories means:
a) Denting
b) Breaking
c) Melting
d) Hardening
5. Comparison between theoratical quantity and actual quantity is:
a) Quality assurance
b) Reconcilliation
c) Qualification
d) Caliberation
. A document or set of documents that serve as basis for batch
documentation:
i) Batch record
j) Master record
k) Master formula
l) Backup record
2. Medium used for the disintegration of buccal tablets
e) Gastric enzymes
f) Simulated intestinal fluid
g) Acidic medium
h) Water or buffer solution
3. Why there is need to measure hardness of tablet?
e) To adjust machine pressure
f) To check disintegration
g) To maintain disintegration
h) All of the above
4. In tablet friability apparatus, maximum weight loss from the three samples
should'nt be more than
a. 4.0%
b. 0.1%
c. 2%
d. 1.0%
5. Measuring equipment should be calibrated according to a plan on
a. Twice a day
 b. Weekly basis
c. After three day
d. Daily basis
**Option "D" of all these mcqs is correct**
A comparison between the theretical quantity and the actual quantity is:

a) Reconciliation
b) quarantine
c) quality unit
d) All of these

Any product that has completed all processing stages up to but not
including,final packaging:

a) Bulk product
b) Batch number
c) finished product
d) in process control

Unit of measuring hardness is:

a) kg/cm2
b) 5 to 10 kg/cm2
c) 2 to 10 kg/cm2
d) 3 to 10 kg/cm2

Factors affecting the hardness;

a) compression of tablet
b) slugging
c) amount of binder
d) both a & c
Apply the test for uncoated tablets operating the apparatus for the time
specified in the individual monograph these are;

a) sublingual tablets
b) Delayed release tablets
c) buccal tablets
d) plain coated tablets
1. Tablet hardness should lie between:
 a. 2 to 5 kg/cm2
b. 5 to 10 kg/cm2
c. 10 to 15 kg/cm2
d. 15 to 20 kg/cm2
2. Pessaries are type of suppository intended for:
a. Vaginal use
b. Rectal use
c. Urethral
d. None of the above
3. The relative standard deviation determined from the content
uniformity test of suppository (10 dosage units) should be less than or
equal to:
a. 3%
b. 4%
c. 5%
d. 6%
4. For tablet with diameter smaller than the mean diameter, the deviation
obtained will be a :
a. Positive value
b. Negative value
c. Both a and b
d. None of the above
5. Suppositories available to be inserted in a nose are known as:
a. Pessaries
b. Ear cones
c. Nasal bougies
d. None of the above

Suppository is considered disintegrated when:

a) Completely dissolved
b) Dispersed into its component parts
c) Become soft
d) All of these

Any product that has completed all processing stages up to but not
including,final packaging:

a) Bulk product
b) Batch number
c) finished product
d) in process control
Tablet hardness should lie between:

a) kg/cm2
b) 5 to 10 kg/cm2
c) 2 to 10 kg/cm2
d) 3 to 10 kg/cm2

Which method give the best hardness

a) granulation
b) slugging
c) lagging
d) wet granulation
Apply the test for uncoated [Link] 4 hours lift basket & observe the
tablets all the tablets isintegrated these are;

a) sublingual tablets
b) Delayed release tablets
c) buccal tablets
d) plain coated tablets

1) Partly processed product that must undergo further manufacturing

steps before it becomes a bulk product is known as

i) Finished product
ii) Batch product
iii) Intermediate product
iv) Bulk product

2) Any product that has completed all processing stages up to, but not
including final packaging is known as

i) Finished product
ii) Batch product
iii) Intermediate product
iv) Bulk product

3) Solid bodies of various weights, and shapes adapted for introduction

into rectal, vaginal or other orifice of human body is called
i) Tablet
ii) Capsule
 iii) Suppository
iv) Granules
4) The amount of tablet required for the weight variation are
i) 5
ii) 10
iii) 20
iv) 30
5) Pessaries are the type of suppository intended for
i) Nasal use
ii) Oral use
iii) Rectal use
iv) Vaginal use

1. A document or set of documents that serve as a basis for the batch

documentation is called:
A) Batch record C) Master record
B) Calibration D) Qualification
2. Crushing test is also called:
A) Friability test C) Weight variation test
B) Hardness test D) Melting range test
3. Pharmaceutical quality system includes:
A) Quality assurance C) GMPs
B) Sanitation and hygiene D) All of above
4. A comparison between theoretical quantity and actual quantity:
A) Reconciliation C) In-process control
B) Calibration D) Validation
5. No suppository should differ from the average weight by more than:
A) 15% C) 10%
B) 5% D) 20%
i) Blank batch Record is also known as:
a) Master Formula
b) Master Record
c) Batch Record
d) None of these
2. Hardness is also called as
a) Crushing test
b) Weighing test
c) Both a and b
d) None of these
3. Unit of measuring hardness is
 a) cm3
b) Kg
c) Kg/cm2
d) Kg/cm3
4. Time of disintegration of buccal tablets is
a) 6 hours
b) 4.5 hours
c) 4 hours
d) 3 hours
5. Suppositories available for vaginal use are called as
a. Nasal cones
b. Bougies
c. Pessaries
d. None of these
6. Suppositries are
a) Single dose
b) double dose
c) both of them
d) None
7. For physical test of suppositries
● cut longitudinally
● cut in oposite direction
● Cut in centre
● none
8. suppositories inserted in nose
a) .bougies
b) .cones
● .Pessaries
c) All of them
9. Suppositries inserted in ear
● bougies
● .cones
● pessaries
● .none
10. Good result for mechanical strength test.
● 1.8_2kg pressure
● .2.1_3
 ● .5_6
● 7_9
11.A document or set of document that serves as a basis for batch
documentation called
● Master record
● Batch record
● BAtch number
● all
12. Basket rack assembly consists of -transparent tubes
● 6open ended
● 3 open ended
● .4open ended
● 5open ended
13. In mechanical strength,how much time is needed to break suppositries
during test?
● .1minute
● 2minutes
● 3minute
● 4 minute
14. Pressure applied on suppositories for crushing test
● 1.8 to 2 kg
● 2 to 3.8 kg
● 4 to 5 kg
● 3 to 6 kg
15. In content uniformity test, RSD is less than or equals to
● 5%
● 6%
● 7%
● 8%
16. A product with all processing stages except final packaging is
● Finished product
● Bulk product
● Batch
● Pharmaceutical product
1. Measure of mechanical integrity of tablets is based on
a. Dissolution time
b. Disintegration Time
a. Breaking force or Hardness
c. Friability

2. Unit for measuring hardness is

a. kg/m2
d. g/m2
e. kg/dm2
b. kg/cm2

3. In the paddle apparatus, the paddle may be coated to make it________?

a. Inert
f. Smooth
g. Sterile
h. Strong

4. Which of the following activities not fall under the job description of
manufacturer?
a. Production
c. Sale
i. QC
j. Distribution

5. If the drug content in one dosage form for the content uniformity test of
suppositories falls below the lower limit of 75%, the batch is __________?
a. Passed
d. Rejected
k. Tested for additional 20 units.
l. Tested for additional 10 units.

. A company that carries out operation such as processing, packaging,

repackaging, labeling and relabeling is:
A) calibration C) manufacturer
B) in-process control D)
2. The relationship between values indicated by instrument for measuring,
controlling, or the values represented by a material measure.
A) batch record. C) validation
B) Calibration. D) Qualification
[Link] of quality assurance which ensures that products are produced and
controlled to the quality standard?
A) GMP C) GCP
B) GLP D) None
4. What was the aim for GMP?
A) Contamination C) quality
assurance
B) confusion D) both A and B
5. Concept that covers all the matters individually and collectively to
influence the quality of product?
A) GMP C) None.
B) Quality assurance D) Production
and control operations
) To verify that the suppositries can be transported under normal conditions
and administered to the patient:
A) Crushing test C) physical tests
B) liquefaction time test D) melting range test
2. What are the suppositries called which are used for ear?
A) bougies C) ear cones
B) pessaries D) None
3. Solid, single dose preparations which are used for rectal, vaginal use are?
A) Suppositries C) IM
B) Tablets D) IV
4. Checks performed during production and control of the equipment maybe
regarded as a part of _____?
A) qualification C) In-process
control
B) Master formula D) None
5. If the average of the limit specified in the potency definition in individual
monograph >100% is?
A) Limit A C) Both A and B
B) Limit B D) None.
In test for aromatic ring if yellow precipitates formation occur then it indicates the presence of
a) Aliphatic compound
b) Aromatic compound
c) Non-Aromatic compound
d) None of these
To ensure the consistency in weight of a dosage form during manufacturing of batch which test
is performed
a) Fraibility test
b) Weight variation test
c) Hardness test
d) Thickness test
In test for functional group if CO2 elimination occurs then it indicate the presence of
a) Alcohol
b) Carboxylic acid
c) Ether
d) Ester
Which route of administration bypass the alimentary canal
a) I.V
b) I.M
c) Oral
d) a and b
To check the package integrity which test is performed
a) clarity test
b) pH
c) Leakage test
d) None of these