37 Important MCQs

Unit –V
(With Solutions)
Pharmaceutical Quality Assurance
BP 606T
By
Dr. Mahendra Pratap Singh
Assoc. Prof. & Vice Principal
Krishnarpit Institute of Pharmacy
Prayagraj, India
 Question.1:- Which of the following is an important
aspect of Equipment validation?

a) Instructional Qualification
b) Performance Qualification
c) Process Qualification
d) Process Validation

Answer: b) Performance Qualification

Question.2:- According to FDA “Validation is defined
as establish documented evidence which provides a
high degree of assurance that a specific process will
consistently produce a product meeting its
predetermined specifications and quality attributes.

a) True
b) False

Answer: a) True
Question.3:- Calibration is a process that
demonstrates a particular instrument or device
produces results within specified limits, as compared
to those produced by a traceable standard over an
appropriate range of measurements.

a) True
b) False

Answer: a) True
Question.4:- Company has purchased 3 capsule filling
machines, all are exactly alike. What type of
qualification studies do you need to perform?
a) IQ & OQ in all and PQ in only one
b) IQ,OQ and PQ in all three
c) Only PQ
d) Only IQ

Answer: a) IQ & OQ in all and PQ in only one

In similar equipments Installation Qualification and
Operational Qualification are performed on all but
Performance Qualification will be on any one
Question.5:- Cleaning validation is the methodology
used to assure that a cleaning process removes
chemical and microbial residues of the active,
inactive or detergent ingredients of the product
manufactured in a piece of equipment
a) True
b) False

Answer: a) True
Question.6:- Which of the following is not a General
Requirement in a cleaning validation program
a) Written procedures on how cleaning processes
will be validated
b) Written validation protocols in advance
c) FDA approval of new drug application (NDA)
d) Validation report stating whether or not cleaning
process is valid
Answer: c) FDA approval of new drug
application (NDA)
Question.7:- The current FDA Guideline for industry
addressing process validation was issued in-
a) 2005
b) 2008
c) 2011
d) 2013

Answer: c) 2011 (January 2011)

Question.8:- Accuracy of an analytical method is
expresses in terms of?
a) % relative error
b) Mean
c) % relative standard deviation
d) Median

Answer: a) % relative error

Question.9:- Which is/ are the type of process validation-

a) Prospective validation
b) Retrospective validation
c) Concurrent validation
d) Re- validation
e) All

Answer: e) All
Question.10:- Equipment validation is also called-

a) Process Validation
b) Qualification
c) Both a and b
d) None

Answer: b) Qualification
Question.11:- Qualification is broken down in how
many phases-

a) 1 c) 3
b) 2 d) 4

Answer: d) 4
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Question 12:- Process validation involves a series of
activities taking place over the entire lifecycle of the
product and process. How many stages of activities have
been identified in the FDA lifecycle approach to process
validation
a) One c) Three
b) Two d) Four
Answer: c) Three
The Three Stages of Process Validation are:
Stage 1 – Process Design.
Stage 2 – Process Validation or Process Qualification.
Stage 3 – Continued Process Validation.
Question 13:- How many batches we need for
validation?

a) 1 c) 3
b) 2 d) 4

Answer: c) 3
Consideration of validation batches fewer than
three will require more statistical and scientific
data to prove the consistency of process to meet
quality standards.
Question 14:- Which type of process validation we
perform Periodic and After Change

a) Prospective Validation.
b) Concurrent Validation.
c) Retrospective Validation.
d) Revalidation

Answer: d) Revalidation
Question 15:- Process Performance Qualification (PPQ) is
the final stage in the development of the manufacturing
process, and enables all process problems to be
corrected
a) True
b) False
Answer: b) False
The process performance qualification (PPQ) is the
second element of Stage 2, process qualification.
Question.16:- It is also called as pre market validation

a) Retrospective validation
b) Prospective validation
c) Design qualification
d) Concurrent validation

Answer: b) Prospective validation

 Question 17 :- Batches made for process validation
should be
a) same size as the intended industrial scale batches
b) ten times greater than intended industrial scale batches
c) ten times smaller than intended industrial scale batches
d) can't say

Answer: a) same size as the intended industrial

scale batches
Question 18:- When a previously validated process is
being transferred to a third party contract manufacturer
or to another manufacturing site which type of
validation can be done
a) Retrospective validation
b) Design qualification
c) Concurrent validation
d) Prospective validation

Answer: c) Concurrent validation

Question 19:- The guidelines that describe the Analytical
Method Validation – Text & Methodology are?

a) ICH Q2
b) ICH Q1
c) ICH Q8
d) ICH Q9

Answer: a) ICH Q2
ICH Q2 R1 - Analytical Method Validation
– Text & Methodology
Question 20 :- Equipment Validation must be always
done by?
a) User
b) Vendor
c) Manufacturer
d) Dealer

Answer: a) User
Question 21 :- Regulatory basis of process validation
is available in-

a) FDA
b) USP
c) IP
d) BP

Answer: a) FDA (Food and Drug Administration)

Question 22 :- Providing documented evidence that a
method/product does what it intends to do is termed as
a) Qualification
b) Validation
c) Calibration
d) Verification

Answer: b) Validation
Question 23 :- Which process validation is validation of a
process for a product already in distribution based upon
accumulated production, testing and control data.
a) Retrospective validation
b) Design qualification
c) Concurrent validation
d) Prospective validation

Answer: a) Retrospective validation

Question 24 :- If the purchaser has specified that the
equipment is going to run in a range of 50-150 RPM
and will draw a specific amount of power, how will he
verify that the equipment is achieving those
operational requirements?
a) Design Qualification
b) Installation Qualification
c) Operational Qualification
d) Performance Qualification

Answer: c) Operational Qualification

Question 25 :- Precision is independent of accuracy

a) True
b) False

Answer: a) True
Question 26 :- Warehouse serve as a key connection
between manufacturing and ________ for finished
products
a) Employees
b) Customers
c) Storage facilities
d) Warehouses

Answer: c) Storage facilities

Question 27 :- Climate-controlled warehousing
space include control of-

a) Temperature
b) Humidity
c) Both a and b
d) None of the above

Answer: c) Both a and b

Question 28 :- Many warehouses utilize a ________ to
receive, store, and retrieve products.
a) Serial Process
b) Warehouse management system (WMS)
c) Storage system
d) Bill of lading

Answer: b) Warehouse management system (WMS)

Question 29 :- FIFO stands for-

a) First in first out

b) Far in far out
c) First invent first out
d) First envintory first outstanding
Answer: a) First in first out
FEFO = First Expire First Out
LIFO = Last In First Out
Question 30 :- A common saying in GMP that "if it is
not documented it never _________ .

a) Happened
b) Reported
c) Analysed
d) Taught
Answer: a) Happened

“If it is not documented it never Happened”

Question 31 :- The documents should be retained for
____ year after the expiry date of the product
concerned.
a) 3 Months
b) 6 Months
c) 1 Year
d) None

Answer: c) 1 Year
Question 32 :- Material management is an important
management tool which will be very useful in getting-

a) Quality
b) Quantity of supplies
c) Right time
d) All of the above

Answer: d) All of the above

Question 33 :- Basic principles of material management
include-
a) Effective management & supervision
b) Sound purchasing methods
c) Effective purchase system
d) Simple inventory control programme
e) All of the above

Answer: e) All of the above

Question 34 :- Functional areas of material management
are-
a) Purchasing
b) Central service supply
c) Central stores
d) pharmacy
e) all of the above

Answer: e) All of the above

Question 35 :- Economic order of quantity(EOQ) can be
understood as-
EOQ= Average Monthly Consumption X Lead Time [in
months] + Buffer Stock- Stock on hand

a) True
b) False

Answer: a) True
Question 36 :- In ABC analysis "C" items have-

a) Tight control
b) Moderate control
c) Ordinary control
d) None

Answer: c) Ordinary control

“A" items have- Tight control
“B" items have- Moderate control
Question 37 :- In VED analysis “V" stand for-

a) Validation
b) Validity
c) Vital
d) None

Answer: c) Vital – Shortage can not be tolerated

“E“ Essential– Shortage can be tolerated for a short period
“D" Desirable- Shortage will not adversely affect