QA 6th sem MCQS – Quality Assurance b pharmacy. Hello friends, welcome here, you can see below some multiple choice questions are given below of sixth semester Quality Assurance subject.

QA 6th sem MCQS

Quality Assurance b pharmacy

6th semester subject of Quality Assurance b pharmacy needs multiple choice questions are here below:

1:- It is responsibility of head of Production

a) Maintain production records

b) Validation

c) Both a and b

d) None

a) Answer: a) Maintain production records

2:- Which of the following is key Person

a) Head of Procuction

b) Head of QA

c) Head of QC

e) All of above

a) Answer: d) All of above

Question.3:- Clean rooms are classified According to the

a) The number and size of atoms.

b) Air checks per hour

c) Material being processed

d) All of the above

Answer: a) The number and size of particles Permitted per volume of air.

Question.4:- The size of airborne particles that serve As a parameter for environmental monitoring and Classification of clean rooms include

a) ≥0.5 µm and ≥ 5.0 µm

b) ≥ 0.10 µm and ≥ 15.0 µm

c) ≥ 0.87 µm and ≥ 50.0 µm

d) ≥ 1 µm and ≥ 15.0 µm

Answer: a) ≥0.5 µm and ≥ 5.0 µm

Question.5:- Class 100 clean room is Equivalent to which ISO class clean room.

a) Class 5

b) Class 6

c) Class 7

d) Class 8

Answer: a) class 5

Question.6:- Service bay is maintained at which class

a) Class 1 or class 10

b) Class 50 or 10

c) Class 1000 or class 10000

d) None of the above

Answer: c) Class 1000 or class 10000

Question.7:- The purpose of environment modeling is

a) Microbiological control

b) Environment control

c) Both

d) None

Answer: c) Both

Question.8:- The efficiency of HEPA filter should be ___ at 0.12 micron particle size

a) 99.99%

b) 95.55%

c) 93.22%

d) 90.99%

Answer: a) 99.99%

Question.9:- Air pressure differentials should be Checked –

a) Yearly

b) 6 months

c) 5 days

d) Daily

Answer: d) Daily

Question.10:- Major types of contaminants Found in pharma industry

a) Bacteria

b) Air molecule contaminants

c) Chemicals

d) Metallic Particles

e) All of the above

Answer: e) All of the above

.11:- Contamination may be caused by

a) Poor hygiene practices

b) Inadequate cleaning

c) Residual cleaning agents

d) All of the above

Answer: d) All of the above

12:- Highest air pressure is maintained in

a) Clean room

b) Gowning area

c) Factory hallway

d) None of the above

Answer: a) Clean room

13:- 5P’s covers People, Premises, Product, Processes and Procedures

a) True b) False

Answer: a) True

Question 14:- Manufacture of sterile medicines does not Require strict controls on Line clearance and Line opening

a) True b) False

Answer: b) False

15:- Quality is built into every step of the Process (quality-by-design) as products cannot be 100% tested at the end of manufacture

a) True

b) False

Answer: a) True Question.

16:- HVAC System is used for

a) Premises maintenance

b) Environmental Control

c) Sanitization control

d) Aseptic area

Answer: b) Environmental Control

17 :- Batch Records must be Legible, Accurate, Factual, Timely, Permanent, Traceable and retained.

a) True

b) False

Answer: a) True

18:- Good Manufacturing Practice is Concerned with

a) Production

b) Quality control

c) Both

d) None

Answer: c) Both

19:- Quality Control is concerned with

a) Sampling

b) Specifications and testing

c) Documentation and release procedures

d) All of the above

Answer: d) All of the above

20 :- Airlock doors should be equipped With systems that

a) Prevent simultaneous opening of both doors

b) Allow simultaneous opening of both doors

c) Both as necessary

d) Not specified

Answer: a) Prevent simultaneous opening Of both doors

21 :- Grade B area comes under which ISO Standard?

a) ISO 5

b) ISO 6

c) ISO 7

d) ISO 8

Answer: c) ISO 7

22 :- Bioburden defined as the number of Bacteria living on a surface that can not been sterilized.

a) True b) False

Answer: a) False

23 :- What should be frequency of HEPA Filter integrity testing?

a) Daily

b) Weekly

c) 6 month

d) Yearly

Answer: d) Yearly

QA mcq with answers

Question.1:- Type II glass is called as-

a) General soda lime glass

b) NP glass

c) BS glass

d) Treated Soda lime glass

Answer: d) Treated Soda lime glass

Question.2:- What is tamper evident package

a) Indicate the evidence of opening of package

b) Opened package

c) Unsealed package

d) Envelop or pouch

Answer: a) Indicate the evidence of opening of package

Question.3:- Thermoplastics are

a) Gets softened on heating

b) Can be molded

c) Does not degraded by repeated heating

d) All of the above

Answer: d) all of the above

Question.4:- The package that comes in contact with Formulation directly is called-

a) Primary package

b) Secondary package

c) Primary and Secondary package

d) Tertiary package

Answer: a) Primary package

5:- Following is not a primary packaging.

a) Ampoule

b) Bottle

c) Cartoon

d) Strip packaging.

Answer: c) Cartoon

Question.6:- Edge protection is required in-

a) Primary pack

b) Secondary pack

c) Tertiary pack

d) None of these

Answer: c) Tertiary pack

Question.7:- The yellow colour glass is manufactured By adding

a) Feric oxide

b) Cupric oxide

c) Cadmium Sulfide

d) Cobalt

Answer: c) Cadmium Sulfide

Question.8:- Number ‘6’ on plastic containers refers That it is manufactured using-

a) Polyethylene

b) Polystyrene

c) Polyvinyl

d) Polypropylene

Answer: b) Polystyrene (PS)

Question.9:- Water attack test is used to identify the Alkalinity in-

a) Type-I glass

b) Type-II glass

c) Type-III glass

d) Umber coloured glass

Answer: b) Type-II glass

Question.10:- As per ICH Stability Zone India Falls under which stability zone-

a) Zone I Temperate Zone b) Zone II Mediterranean/Subtropical Zone

c) Zone III Hot Dry Zone

d) Zone IV a Hot Humid/Tropical Zone & Zone IVb Hot /Higher humidity

Answer: d) Zone IV a Hot Humid/Tropical Zone & Zone IVb Hot /Higher humidity

Question.11:- Light transmission test for glass is Measured at spectral region of

a) 290nm to 450nm

b) More than 500 nm

c) 500nm- 900 nm

d) None

Answer: a) 290nm to 450nm

12:- Annealing is a process of-

a) Cooling

b) Heating

c) Melting

d) Titrating

Answer: a) Cooling

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Conclusion

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