MULTIPLE CHOICE QUESTIONS

'
1. According to dictionary Quality is Degree of___.
A) Excellence 8) Agreement C) Greatness D) None of these
2. According to WHO QC is part of___.
A) GLP B) GCP C) GMP D) None of these
3. QC activities focus on identifying ___ in actual product produced.
A) Defects B) Strengths C)Both A& B D) None of these
4. To iden tify and prep are the nece ssary SOP 's related to the cont rol of qua lity is a resp onsi bilit y
of ___ Department.
A) Production B) QA C) QC D) None of these

5. GMP e�sures which of the following Parameters___.

A) Quality B) Safety C) Efficacy D) All
6. During sampling and testing in - process materials should be tested for which of the following
para met er?
A) Identity B) Strength C) purity D) All
7. Which of the following department holds responsibilities for Quality_ monitoring or audit?
A) QC B) QA C) production D) All
8. To Approve or reject the starting materials, packaging materials, and intermediate, bulk and
finished products is responsibility of which department?
A ) QC B) QA . C) production D) All
'
A high leve l of pers onal hygi ene shou ld be follo wed and obse rved by all thos e concerned
9.
w ith ___ processes.
, A) Man uf ac tu ring B) Tra nsp orting C) Warehousing D) None of these
10. Duri ng exam inati on and testin g of samp le at least.__ test shou ld be cond ucted on each lot of
•,, component drug product to verify identity.
A) Two 8) _Three C) One D) None of these
ll. is re�erve sample should contain at leas
??'e t the quantity needed for all tests required to
temune the sterility and pyrogen testing
·-. --
A) Twice B) Thrice
. C) similar D) None of these
12. The scope of sani·tati· on anct hy
giene covers---·
A) Personnel B) prenu.ses C) Equipments D) All
13 . . .
!;'; � hed �roducts co_ntaining active ingredients should comply with -- composition
h ar k eting authonzation.
-
A) �ualitative B) Quantitative C) Both A& B D) None of these
l4. Which department 1· s respo
nsible for evaluation of Ba tch records?
A) QA B) QC
· C) Both A& B D) None of these
15. Generally k ey posts should be occupi
_ _ ed by --- personnel.
A) Part time B) Full time . C) Both A& B D) None of these

. .
KEYS
1. A 2. C 3. A 4. B 5. D 6. D
7. A 8. A 9. A 10. C
' 11. A 12.D
13. C 14. B 15. B
 MULTIPLE CHOICE QUESTIONS
1. Total Quality Management is a description of the .
A) Culture B) Attitude C) organization D) All
2. TQM aims at long term success through .
A) Customer satisfaction · B) Owner Satisfaction
C) Management Satisfaction D) All
3. Which of the following is the binding mortar in elements of TQM?
A) Communication B) Ethics C) Recognition D) Training
4. Which of the following is the Roof in elements of TQM?
A) Integrity B) Trust C) Recognition D) Leadership
S. Which of the following is not the foundation element of TQM?
A) Ethics B) Integrity C) Trust D) Communication
6. Which of the following is building block of TQM?
A) Training B) Teamwork C) Leadership D) All
7. TQM does not work in an environment where employees __ each other.
A) Appreciate B) Criticize C) Support D) None of these
8. - is one of the most important factors necessary to implement TQM.
A) Trust B) Recognition C) Leadership D) None of these
9. To become successful in business __ is a key element.
A) Motivation B) Teamwork C) Appraisal D) None of these
10. Quality, improvement team deals with problems.
A) Specific B) General C) both A& B D) None of these
11. Provides direction to the entire process of TQM.
A) Trust B) Leadership C) Communication D) Integrity
12. From Foundation to the roof of TQM are bound together by .
A) Communication B) Recognition C) Leadership D) None of these
•

13. Kaoru Ishikawa is best known for the development of quality tools called diagrams.
A) cause-and-effect B) Fishbone C) Ishikawa D) All
14. is often referred to as the "father of quality control.''
A) Kaoru Ishikawa B) W. Edwards Deming ·
C) Genichi Taguchi D) None of these
15. In which Year Joseph M. Juran went to Japan to work with manufacturers and teach classes on
quality?
A) 1945 B) 1964 C) 1954 D) 1925

KEYS
1. D
2. A 3. A.
7. B 4. C 5. D 6. D
8. A 9. B
13. D 10. A 11. B 12. D
14. B 15. C
 •

MULTIPLE
•
CHOICE QUESTIONS
1. ICH a unique project that brings together the regulatory authorities of Europe, Japan
and .
A) USA B) Brazil
C) Australia India
D) I
•

2. ICH discusses __ aspects of product registration.

A) Scientific B) Technical
C) Both A & B D) None of these
3. ICH is a joint initiative involving based industry representatives of the EU,
Japan and the US.
A) Regula tor B) Research
C) Both A & B D) None of these
The purpose of ICH is to make recommendation on ways to achieve greater .
4.
A) Quality B) Harmonization
C) Safety · D) Optimization
The focus of ICH has been on the technical requirements for medicinal products
5.
containing .
B) New Drug
A) Prodrug
D) Potent drug
C) Effective drug
6. ICH Qt guideline is for__ .
B) Animal testing
A) Stability testing
D) None of these
C)ADR •

7. ICH Q2 guldeltne is for

A) Cleaning validation --· B) Calibration
C) Analytical validation D) None of these
8. iC)HlmQ3 guideline is for .
purities -- B) Raw materials
C) API D) None of these
9. IC)HT Q4 guideline is for
A est methods --··
C) N B) Pharmacopoeias
ew products development D) None of these
10. iC)H 95 guideline is .for Products.
B1otechnological --
.. C) Cytotxic B) Potent drug
D) None of these
Purpose ofof
influence · t o provide
stability testi ng is · evidence
. how quality varies with time under
A) Temperature · B) Humidity
C) L.ight
.·. D) All
12.
IICH
ike has.produced
. a comprehensl rve set of safety Guidelines to uncover potential risk

A) Carcinogenecity B) Genotoxicity
C) Reprotoxivity D) All
13. ICH Q7 guideline is for Good Manufacturing Practice Guide for •
A) Raw materials B) Excipients
C) API D) None of these

14. The aim of pharmaceutical development is to design a product.

A) Optimized B) Effective
C) Quality D) None of these
15. ICH Q9 guideline is for .
A) Safety assessment B) Quality risk management
C) Product development D) None ofthese

KEYS
1. A 2. c 3.c 4.B s.B 6. A
7. c 8. c 9.B lo.A . 11. D 12.D
13. C 14. C 15.B
 .
MULTIPLE CHOICE QUESTIONS
1. A Systematic approach to development begins with __ objectives.
A) Predefined B) Established
C) Future D) Historical
2. Concept of QbD is based on __ .
A) Validation .B) Calibration
C) Quality risk management D) None of these
3. QbD ensures knowledge gained during development.
A) Process B) Process
C) Both A&B D) None of these
4. . The main objective of QbD is to ensure the of products.
A) Validity B) Quality
C) Efficacy D) None of these
..
5. . Quality by Design is a concept firstly outlined by .
A) Joseph M. Juran. B) Robert Nash
C) Sidney Wiling D) Ishikawa
- 6. FDA in its current Good Manufacturing Practices in __ century initiated QbD.
A) 21'1 B) zo-
C) 19th D) None of these
7. In which ICH guideline Qbd is described?
A) QB B) Q9
C) QlO 0) All
.
8. has encouraged the application of QbD principles to pharmaceutical development.
A)TGA B)FDA
C) MHRA D) None of these
9. QbD Process begins with -----·
... A) Optimization B) Validation
C) Target product profile D) None of these .·
,. 10. forms the basis for design and development of the product.
A) QTPP B) Design Space
C)Pre-formulation D) None of these
11. Which of the following tools are used in QbD Process?
A)PAT B)DOE
C) Risk Assessment D) All
12. Inks the drug development activities with the labeled specifications.
A)PAT B)QTPP
C) Risk Assessment D) All
13. QbD focuses on building quality into __ .
A) Product B) Manufacturing process
C) Both A&B ) None of these
14. CQAs are identified by using .
A) Experimentation B) Quality risk management
•
C) Both A&B D) None of these
15. Which of the following guideline defines Quality risk management?
A) ICH Ql B) ICH Q9
C) ICH QS D) None of these

KEYS
5. A 6. A
1. A 2. C 3. C 4. B
11. D 12. B
7. D 8. B 9.C 10. A
13. C 14. C 15. B
MULTIPLE CHOICE QUESTIONS
1. ISO is a organization.
A) Non-governmental B) Government
C) Semi-government D) None of these
2. Headquarter of ISO is situated in .
A) Delhi B) Geneva
C) Mexico D) London
3. In which year ISO was established?
A)1926 B) 1936
C) 1946 D) 1956
4. ISO is the world's largest developer of .
A) Products B) Standards
C) Software's D) None of these
5. Whose principal activity is to develop technical document?
A) ISO B) TGA
C) WHO D) None of these
6. ISO standards ensure __ of products and services to customers and other users.
A) Quality B) Safety
C) Both A & B D) None of these
7. Greek word ''isos'' means -- .
A) Full B) Total
•
C) Equal D) None of these
•
8. ISO helps in transferring.__ to developing countries.
A) Data B) Technology
C) Documents D) None of these
9. ISO 9000 deals with the fundamentals of .
A) Risk Assessment B) Quality management system
C) Optimization D) None of these
10. ISO 9000 was originally published in year.
A)1987 B) 1967
C) 1977 D) 1947
11. ISO 9003 is for Quality assurance in .
A) Final inspection B) Testing
C) Both A & B • D) None of these
 12. is lite primary focus of a business.
A) Retailer B) Super stockiest
C) Custon1er D) None of these
13. · The ISO 14000 series of standards effectively address the needs of ·
A) Organization B) Mediator
C) Customer D) None of these
14. Guidelines for environmental aspects in product· standards are contained in ISO .
A) 14060 B) 14001
C) 14004 D) None of these
15. ISO 14040, 14041, 14042 and 14043 provide information about topics related to .
A) LCA B) EPE
C)EAPS D)EL

KEYS
1. A 2.B 3.C 4.B 5.A 6.C
7. C 8.B 9.B 10. A 11.C 12.C
13A 14.A 15.A
MULTIPLE CHOICE QUESTIONS
1. NABL is body.
A) Autonomous B) Private
C) Both A & B D) None of these
2. NABL comes under the aegis of__ .
A)DBT B) DST
C)SERB D) None of these
3. NABL is registered under___ act,t
A)D&C B) Societies
C) environmental protection D) None of these
4. NABL was established with the objective to provide
party assessment. with a scheme for third-

A) Government B) Industry
C) Society D) All
5. Government of has authorized NABL as th l · ·
Calibration laboratories. . e so e accreditation body for Testing and
A) Australia B)US
C)Japan D) India
6. N ABL provides services to laboratories that ·
accordance with NABL. are performing tests I calibrations in

A) Utility support B) Emergency

C) Laboratory accreditation D) None of these

7. NABI: has agreements with .

A) ILAC B) APLAC
C) Both A&B · 0) None of these
8. NABL specifies the general requirements for the competence to carry out __ and--·
A) Calibration & validation Tests & Calibration
B)
C) Data collection & Documentation D) None of these
9. NABL Secretariat is functioning from its office situated in .
A) New Delhi B) Mumbai
C) Nagpur D) Lucknow
10. Laboratory Accreditation enhances in accepting testing I calibration reports
issued by accredited laboratories.
•
A) Customer satisfaction B) Customer satisfaction
C) Customer confidence D) All
11. NABL reduces trade barriers and providing greater thrust to__ .
A) Import B) Export
C) Both A & B D) None of these • •
A copy of __ Report will be provided to ~aboratory for taking necessary corrective
12.
action.
A) Formal assessment B) Final Assessment
C) Pre-Assessment D) None of these
13. Laboratories are required to submit sets of duly filled in application forms for each
field of testing I calibration.
A) Seven B) Three
.
C) Five D) Nine
14. Accreditation to a laboratory shall be valid for a period of Years.
A) Five B) Three
C)Six D)Two
15. Laboratory shall apply for Renewal of accreditation lo it at least months before the
expiry of the validity of accreditation.
A) Eighteen B) Twelve
C) Six D) Three

KEYS
1. A 2.B 3.5 4. D 5. D
rc 8.B 9. A 10. C .11. B
13. C 14. C 15. C
 MULTIPLE CHOICE QUESTIONS
1. In pharmaceutical industry an employee should have of the job description.
A) Clarity B) Understanding
C) Both A & B D) None of these
2. A job description is an organized and factual statement of the of a specific job.
A) Responsibilities B) Tasks
C) Work schedule D) None of these
3. Basically the job description should indicate .
A) what is done B) why it is done
C) where it is done D) All
4. Key personnel positions in the organization have a impact on the working of the
organization and quality of the products produced.
A) Direct B) Indirect
C) Both A & B D) None of these
s. Trained person means person having __ towards work.
A) Knowledge B) Skill
C) Attitude D) All
6. Personnel Records are records pertaining to of an organization.
A) Management B) Personnel
C) Structure D) None of these

7. T~ approve or reject starting, packaging material is a responsibility of .

A) Head of Q.C department B) Head of production Department
C) Both A & B D) None of these
8. Knowledge refers to the background expected in a person.
A) Theoretical B) Practical
C) Both A & B D) None of these
9. A high level of personal hygiene should be maintained by staff working in.__ areas.
A) Warehousing B) Manufacturing
C) Both A & B D) None of these
10. Personnel records Contain information related to personnel.
A) Factual B) Comprehensive
C) Both A & B D) None of these

KEYS
1. C 2. A 3. D 4. A 5. D 6. B
7. A 8. A 9. B 10. C
MULTIPLE CHOICE QUESTIONS
1. The factory building used for manufacturing of drug product shall be so situated and shall
have such measures to avoid the risk of . .
A) M"ixmg
· B) Contamination
C) Hazard D) None of these
2. Which of the following is included in External environment?
A) Open sewage B) Drain
C) Public lavatory D) All
3. The premises/ building shall conform to all conditions laid down in
A) Pharmacy Act B) Factories Act ---· .
C) Drug and Cosmetic act D) None of these
4. In which year Factories act came into existence?
A) 1958 B) 1948
C) 1968 D) 1978
5. The premises used for manufacturing, proce · .
testing should be compatible with ssmg, ~arehousmg, packaging, labeling and
____ operations carried t ·
A) Quality control B) F . ou in same area.
uf . ormulation development
C) Man ac t unng • D) none of th ese
b. Adequate space should be provided for logi ca 1 an d orderly pl
A) Raw materials B) E . acement of .
qwpments
C) Packaging materials D) s
.. . . . . pare parts
1. The premises/building should be designed an d constructed t
O prevent the entry of insects,
bi rd s, ro d ents
A) Insects B) Birds
C) Rodents D) All
s. Which of the f~l.lo_w;~g-~ondition is required in Storage areas to meet the environmental
conditions?
• I
' I
A) . Temperature B) Humidity
C) Both A& 8 D) None of these
9. Facilities for Toilets should not communicate directly with area.
A) Production 8) Storage
· ' C) Both A&:B D) None of these
10. A detailed __ should be there for cleaning and sanitation of drains.
· A) Protocol B) Report
C) SOP D) None of these
11. Facilities where sterile products are manufactured air should be supplied under,
___ differential pressure.
A) Constant B) Positive
C) Negative· D) None of these
12. Products which are filled aseptically, the filling room shall meet condition.
A) Grade A B) Grade B
C) Grade C D) Grade D

KEYS
2. D 3. B 4. B 5. C 6. B
1. B
9. C 10. C 11. B 12.B
. 7. D 8. C
MULTIPLE CHOICE QUESTIONS
1. Size of the equipment is decided based on the of materials.
A) Volume . B) Nature
C) Chemical composition D) None of these
2. Which of the following is not an example of equipment?
A)HPLC B)Mixer
C) Dryer D) Aspirin
3. The design of the equipment should be according to its__ .
A)SOP B)URS
C) Working D) None of these

4. __ Sizes are directly related to the size of the processing equipment.

A) Batch B) Particle
C) Both A & B D) None of these
s. Which of the following is the operation criterion for equipment?
A) Size B) Speed
C) Effectiveness D) All
6. Material used for construction of equipment should be non reactive with .
A) Raw Materials B) API
C) Products D) All
7. Availability of from supplier with equipments is important for operating, handling,
validation and qualification.
A)SOP B) Design

C) Manual D) All

8. Which of the following is important for maintenance of equipment?

A) Frequency of maintenance B) calibration
C) validation D) All
9. Which of the following is important during purchase of raw materials?
A) Quality B) Purity
C) Identity D) All
10. For the storage of general product room temperature should be __ .
A) 30°C B) 50°C
C) 20°C D) 40°C
•
11. Light sensitive material should be stored in container.
A) Transparent B) Amber color
C) Plastic D) None of these ·

5. D 6. D
1. A 2. D 3. B 4. A
7. D 10. A 11. B
8. D 9. D
 MULTIPLE CHOICE QUESTIONS
1. Packaging is the of enclosing or protecting products for distribution, storage, sale,
and use.
A) Science B) Art
C) Technology D) All
2. Packaging also refers to the packages.
A) Designing B) Evaluating
C) Producing . · D) All
3. Secondary packaging materials are used to improve the of the product.
A) Therapeutic effectiveness B) Appearance
C) Quality D) Strength
4. In powdered glass test indicator is used.
A) Methyl red . B) Methyl orange
C) Eriochrome black T D) Phenolphthalein
5. In powdered glass test leached alkali is titrated with __ N Sulphuric acid.
A) 2 B) 0.01
C) 0.02 D) 1
6. Water attack test is only used for __ glass containers.
A) Type I B) Type II
C) Type m D)None of these
7. In water attack test each container is filled to % of its overflow capacity.
A) 60 B) 70
C) 80 D) 90
8. In ltydrolylic rcsl 8 t
__ M HCI. anco test of glass contalncr, tes! solutlon In conlcaJ flask Is titrated With
A) 0.01
C) t B) 0.02
9. I11
arsei,fc test the residue is dried
rn2
In an oven at p C for 30 min
A) 100 --
C) 130 B) 121 •
10. In arsenic t t Ab D) 200
es sorbance of lite solution was measured at nm
A) 840 --
C) 550 B) 746
11. In internal b i D) 210
urst ng pressure test the test bottle is filled wlth .
A) Water --
C) HNQJ B)HCL
12. In light tr . i . D) None of these
more tha:nsm s:~n test for coloured glass the observed light transmission should be not
A) 10
C) 30 B) 20
D) SO
 13. In Q.C test of metal container a sample of tubes are selected from the lot for testing.
A) 25 B) 50
C) 75 D) 100
14. In leakage test for plastic container no. of containers are filled with water.
A) 10 B) 15
C) 20 D) 25
15. In water vapor permeability test each container is allowed to stand for days.
A) 10 B) 14
C) 28 D) 30

KEYS
1. D 3. B 4. A 6. B
7. D 9.c 10. A 12. A
13.8 1s.8
 MULTIPLE CHOICE QUESTIONS
1. · ·
In non-cl1n1cal . cxpcnmcn
laboratory studies · t s ar e performed under __ conditions.
A) .Laboratory B) Atmospheric
C) Both A& B D) None of these
2. The term GLP is most commonly associated with the industry.
A) Pharmaceutical B) Petrochemical
C) Polymer . D) None of these
3. \Vhich subpart prescribes GLP for conducting non-clinical laboratory studies that supports
applications for research or marketing permits for product regulated by FDA?
A) Subpart B B) Subpart A
C) Subpart K D) None of these
4. Sub part B of GLP deals with. .
A) General provisions B) Organization & Personnel
C) Disqualification of testing facilities D) Records & Reports
5. In GLP, it is prescribed that study director should be a .
A) Doctor B) Pharmacist
•
C) Scientist D) None of these
6. Each individual engaged in the conduct of nonclinical study shouJd have .
A) Education B) Training
C) Experience D) All
7. From which source Audit information in laboratory is derived?
A) Personnel B) Documentation
C) Observation of testing procedures 0) All
8. Sub part C of GLP deals With .
A) Facilities
B) Organization & Personnel
C) Test & Control articles D) Disqualification of testing facilities
9. A minimum of sq. feet of floor space should be provided for each analyst.
A) 250 B) 150
C) 200 D) 100
10. Laboratory lighting should be even and should provide a minimum of foot candle
light intensity at all working surfaces. -
A) 100 B) SO
C) 150 D) 200
11. A noise level of around __ dB does not cause problem to animals.
A) 500 B) SO
C) 100 D) 250
12. According to animal care facilities, not more than __ single cages should be kept in one
room.
A) 50 B) 20
C}lO 0) 60

13. According to animal care facilities, Container for water should be made of __ material.
A) Glass B} Plastic
C) Iron 0) Both A &B
14. According to animal care facilities, Monkeys up to kg trapped together may be kept in
gang cages.
A) 10 B)3
C)6 D)9
15. Fore guinea pigs Floor pens should have area of cm2•
A) 100 B) 1000
C} 500 0) 550

KEYS
3.B 4.B 5. C 6. 0
1. A 2. A
10. A 11. B 12. D
7. D 8. A 9.B
13. D 14. B 15.B
 MULTIPLE CHOICE QUESTIONS
1. Complaint about product is an indicator of the Product __ .
A) Quality B) Efficacy
C) Safety D) None of these
2. Person handling complaint should be from Department.
A) Quality management B) Production
C) R&D D) None of these
•
3. Written records involving a drug product shall be maintained for tit least_ year after the
expiration date of lite drug product.
A) One B) Five
C) Three D) Ten

4. In case of certajn 0.T.C. products where ex1,JratJon date is nol glv~n the records should be
o1aint.1ined (or at least for years after the co1111,lclc distribution of the drug product.
A) One B) Two
C) Three seven
D)
5. All decisions and measures taken as a result of a complaint should be recorded and
referenced. in the corrcspondlng records.
A) Master production B) Batch
C) Labeling D) None of these
6.
___ should be performed In an event to identify possible recurrent causes leading to
a negative effect on a product.
•
•
• A) Q.C tests B) Validation
C) Trend analysis · D) None of these
7.
A should be available giving fuJI details about how to handle products complaints.
A)SOP
B) Report
C) Instruction D) None of these
8.
__ department should evaluate all aspects of the received material.
A)QA B)R&D

9. C) QC D) Production
A company may receive returned goods at any of its __ .
A) Production unit B) Warehouse

10. C) Bo~tiA&B D) None of these ·

Quan es rejected and destroyed must be recorded and reconciled in relevant
A) Production Document B) Batch Document ---·
C) Storage Document
D) None of these

KEYS
4. c 5. B
10. B