23 Important MCQs

Unit –II
(With Solutions)
Pharmaceutical Quality Assurance
BP 606T
By
Dr. Mahendra Pratap Singh
Assoc. Prof. & Vice Principal
Krishnarpit Institute of Pharmacy
Prayagraj, India
Question.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

Question.2:- Which of the following is key
person
a) Head of Procuction
b) Head of QA
c) Head of QC
d) All of above

a) Answer: d) All of above

Question.3:- Clean rooms are classified
according to the
a) The number and size of particles permitted per
volume of air.
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
Explanation: 100 ISO 5
1,000 ISO 6
10,000 ISO 7
100,000 ISO 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

Question.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

Question 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

Question 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
 Question 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

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

a) True
b) False

Answer: a) True
Question 18:- Good Manufacturing Practice is
concerned with
a) Production
b) Quality control
c) Both
d) None

Answer: c) Both
Question 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

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

a) True
b) False

Answer: a) False
Question 23 :- What should be frequency of HEPA
filter integrity testing?

a) Daily
b) weekly
c) 6 month
d) Yearly

Answer: d) Yearly