Question Bank with Answer key

Subject: Pharmaceutical Quality Assurance (BP 606T)

Year and Sem: T. Y. B. Pharm. (Sem VI)

Multiple choice-based questions

1 ICH Q 7 represents ________ guidelines.
a. Quality Risk Management
b. Good Manufacturing Practices
c. Lifecycle management
d. Pharmaceutical Development
2 Testing of raw materials and finished products is the responsibility of ______.
a. Stores department
b. Quality Assurance department
c. Production department
d. Quality Control department
3 ___________ is a managerial tool.
a. Quality Control
b. Quality Assurance
c. Production
d. Accreditation
4 Following are tools of QbD except ______.
a. Critical Quality Attributes
b. Process Analytical Technology
c. Risk assessment
d. Design of Experiments
5 ICH Q 8 represents ________ guidelines.
a. Quality Risk Management
b. Good Manufacturing Practices
c. Lifecycle management
d. Pharmaceutical Development
6 Maintaining reference standard and retained samples is the responsibility of ________
department.
a. Stores
b. Quality Assurance
c. Production
d. Quality Control

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7 The validity of NABL accreditation is for ______.
a. Six months
b. One year
c. Two years
d. Three years
8 PDCA cycle consists of ___________.
a. Plan Do Check Act
b. Plan Develop Create Act
c. Plan Develop Correct Act
d. Plan Do Correct Act
9 Bracketing design for stability testing includes _______.
a. Testing samples of all design factors at all time points
b. Testing samples of extreme design factors at all time points
c. Testing samples of all design factors at half time points
d. Testing samples of extreme design factors at half time points
10 Investigation deviations in the manufacturing process is the responsibility of ______
department.
a. Stores
b. Quality Assurance
c. Production
d. Quality Control
11 NABL is an autonomous body established under the aegis of ______.
a. Department of Health & allied sciences
b. Department of Science & Technology
c. Department of Food & Drug testing
d. Department of Pharmaceutical Sciences
12 ___________ is a subset of Quality Assurance.
a. Quality Control
b. Quality Management System
c. Quality Policy
d. Quality Framework
13 ISO 14000 relates to __________.
a. Quality Assurance System
b. Environmental management systems
c. Quality Management System
d. Product Management System

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14 According to Juran, Quality is ________.
a. Customer satisfaction
b. Management's objective
c. Fitness for Use
d. Meeting standards
15 Critical quality attributes and critical process parameters are crucial part of ______ .
a. ISO
b. GMP
c. NABL
d. Quality by Design
16 Which department holds responsibility of quality audits?
a. Quality Assurance
b. Quality Control
c. Production
d. Human Resource
17 Regulatory audit is also known as __________.
a. First party audit
b. Second party audit
c. Third party audit
d. Fourth party audit
18 The buildings used for the manufacture of drugs should conform to all the conditions
laid down in __________.
a. Pharmacy Act
b. Factories Act
c. Drug and Cosmetic Act
d. Companies Act
19 Room classification tests in the “at-rest” condition should be carried out ______.
a. With the equipment installed, HVAC operational, but without any
operators.
b. In the empty room, in the absence of any equipment or personnel.
c. During the normal production process with equipment operating under normal
conditions.
d. With the normal number of personnel present in the room.
20 A job description is an organized factual statement of the _____ of a specific job.
a. Report
b. Policy
c. Schedule
d. Responsibilities

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21 ________ help the managers to make salary revisions, allowances and other benefits
related to salaries.
a. Audit records
b. Deviation records
c. Personal records
d. Master records
22 The highest air pressure is maintained in _____________.
a. Clean Room
b. Gowning room
c. Factory Hallway
d. Store room
23 Air pressure differentials in a clean room should be checked _________.
a. Daily
b. Yearly
c. Biannually
d. Weekly
24 The efficiency of HEPA filters should be _________at 0.22micron particle size.
a. 95.55%
b. 99.99%
c. 93.22%
d. 90.99%
25 The recommended size of area to be swabbed for environmental monitoring of
equipment and apparatus is _________.
a. 10 – 15 cm2
b. 100 – 200 cm2
c. 24 – 30 cm2
d. 2 – 3 cm2
26 Key positions in a pharmaceutical company should be occupied by _____.
a. Consultants
b. Full time personnel
c. Part time personnel
d. External auditors
27 Installation qualification of an equipment verifies that ____.
a. Equipment is operating consistently
b. User requirements are incorporated into equipment design
c. Equipment is installed and calibrated
d. Installed equipment gives quality product consistently for long period

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28 Following products cannot be manufactured in the same manufacturing facility
a. Penicillin products & Antidiabetic products
b. Antiviral product & Anti-inflammatory product
c. Antiviral product & Antihypertensive product
d. Antimalarial product & Anti-inflammatory product
29 The dispensing of raw materials from Stores must follow the principle of _____.
a. First Out Then In
b. Fast Out Fast In
c. Fast In Fast Out
d. First In First Out
30 Approval of release of finished product is the responsibility of ____.
a. Head of Stores
b. Head of Quality Control
c. Head of Quality Assurance
d. Head of Production
31 The following is verified during operational qualification of an equipment.
a. Equipment is installed and calibrated
b. Equipment operates consistently within operational limit
c. Equipment shows satisfactory performance over long period.
d. Equipment is installed and connected to utilities
32 Service bay is maintained at ____________.
a. Class 10
b. Class 20
c. Class 50
d. Class 1000
33 Airlock doors should be equipped with systems that__________.
a. Prevent simultaneous opening of both the doors
b. Allow simultaneous opening of both the doors
c. Prevent simultaneous opening of doors by unauthorized persons
d. Allow simultaneous opening of both the doors by authorized persons
34 Personal records are records of _____ in an organization.
a. Employer
b. Employees
c. Visitors
d. Auditors

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35 In sterile area (Grade A), the limit on microbial contamination in air sample is ____.
a. < 1 CFU/mm3
b. < 200 CFU/mm3
c. < 100 CFU/mm3
d. < 10 CFU/mm3
36 Cleaning of the equipment is a part of ________.
a. Periodic maintenance
b. Predictive maintenance
c. Corrective maintenance
d. Curative maintenance
37 Calibration of an equipment should be performed using _______.
a. Test sample
b. Certified Standards
c. Inhouse standards
d. Reference sample
38 Minimum number of glass containers of 3 ml nominal capacity used for hydrolytic
resistance test are _____.
a. 20
b. 10
c. 5
d. 2
39 Subpart G of GLP for non- clinical laboratory study is _____.
a. General Provision
b. Equipment
c. Facilities
d. Protocol for and Conduct of a nonclinical laboratory study
40 Grammage is used to determine the physical dimensions of the ______ material.
a. Paper and paperboard
b. Thermosetting plastic
c. Glass
d. Metal

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41 The person who approves the protocol for conduct of nonclinical laboratory study is
_____.
a. Sponsor
b. Scientist
c. Study director
d. Quality Assurance Head
42 As per USP, the limit of fragments visible to the naked eye in fragmentation test for
rubber closures is
a. Not more than 500
b. Not more than 100
c. Not more than 50
d. Not more than 5
43 The OECD stands for
e. Organization for Environmental Coordination and Discussion
f. Organization for Economic Cooperation and Development
g. Organization for Environmental Cooperation and Development
h. Organization for Economic Cooperation and Discussion
44 For evaluation of metal container, sample complies with specification limit if
a. Total score is <1000
b. Total score is 100-150
c. Total score is > 150
d. Total score is < 100
45 As per USFDA GLP guidelines, Subpart C is _______.
a. Equipment
b. Facilities
c. Records and Reports
d. Organization and personnel
46 Cobb test measures the ____ of paper and board
a. Ink absorbency
b. Water absorbency
c. Acid absorbency
d. Alkali absorbency
47 The _____ is responsible for the conduct of a nonclinical laboratory study.
a. Study Director
b. Scientist
c. Quality Assurance Unit
d. Laboratory Technician

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48 In the test for volatile sulphides in rubber closure, ______ paper is used.
a. Litmus paper
b. Starch paper
c. Lead acetate paper
d. Mercuric chloride
49 Records of a nonclinical study should be retained for _____ after termination /
discontinuation of the study.
a. One year
b. Two years
c. Three years
d. Five years
50 Neutral glass is also called as ______.
a. Type I glass
b. Type II glass
c. Type III glass
d. NP glass
51 As per USFDA GLP guidelines, Subpart F is _______.
a. Facilities
b. Equipment
c. Records and Reports
d. Test and Control Articles
52 Tear strength measures the _____.
a. Energy required to make puncture in the paper
b. Force that a paper withstands before breaking
c. Degree of resistance offered by paper when it is folded
d. Force required to tear an initial cut in the paper
53 Changes in an approved protocol for conduct of nonclinical laboratory study are
signed by _______.
a. Sponsor
b. Scientist
c. Quality Assurance Personnel
d. Study Director
54 Self sealability test is intended for _____.
a. Rubber closures of single dose container
b. Rubber closures of multi dose containers
c. Plastic closures of single dose containers
d. Plastic closures of multidose containers

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55 The principles of GLP applies to ______.
a. Conduct of clinical studies
b. Conduct of nonclinical studies
c. Conduct of analytical studies
d. Conduct of microbiological studies
56 GLP regulations were implemented by FDA in ______.
a. 1978
b. 1971
c. 1968
d. 1981
57 Type III glass is also known as ________.
a. Soda lime glass
b. Borosilicate glass
c. Treated Soda lime glass
d. Treated borosilicate glass
58 Limit of 0.02 N sulphuric acid for Type III glass in powdered glass test is ________.
a. 8 ml
b. 1 ml
c. 7.5 ml
d. 8.5 ml
59 ______ is the test in which test piece is folded back and forth until rupture occurs
a. Folding endurance
b. Tensile strength
c. Burst Resistance
d. Tear Strength
60 Water attack test is performed on _______ glass
a. Type I
b. Type II
c. Type III
d. Type IV
61 ____ test is specifically used for testing glass containers used for aqueous parenterals.
a. Light transmission test
b. Arsenic test
c. Thermal Shock test
d. Internal bursting pressure test

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62 Corrections to the final report by study director are in the form of _______.
a. Revised edition
b. Oral communication
c. Amendment
d. Revised Version
63 The primary documentation to be reviewed during technical investigation of
complaints is __________.
a. Name, address, phone number and email of a customer.
b. Distribution records
c. Deviation records
d. Complaint files and batch records
64 The final Tier in the Quality documentation system is _____________.
a. Records
b. Work instructions
c. Quality Procedures
d. Quality Policies
65 _____ is at the apex of Quality Management System.
a. Quality Records
b. Quality Manual
c. Working instructions
d. Quality procedures
66 Which is the second step in Handling of complaints?
a. Monthly trend analysis
b. Corrective action
c. Technical investigation
d. Receiving of complaints
67 Microbial contamination of non-injectable product results in _______.
a. Class I recall
b. Class II recall
c. Class III recall
d. No recall
68 The SOP’s are reviewed after _____.
a. One year
b. Two years
c. Three years
d. Five years

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69 The disposal of printed packaging material of pharmaceuticals is done using ______.
a. Incineration
b. Autoclaving
c. Recycling
d. Landfill
70 Complaint investigation is the responsibility of ______.
a. Marketing department
b. Quality Assurance department
c. Production department
d. Quality Control department
71 Documents should be retained for atleast _______ years after the expiry of the
product.
a. One
b. Two
c. Three
d. Five
72 The good material management system ensures the following except _____.
a. Right quality of the product.
b. Stocking large amounts of materials
c. Minimize inventory costs
d. Right delivery time
73 Retrospective validation is performed using data from minimum ________
consecutive batches
a. One
b. Three
c. Five
d. Ten
74 During the qualification of UV-visible spectrophotometer, resolution is measured
using ____.
a. Holmium perchlorate
b. Potassium chloride
c. Potassium dichromate
d. Toluene in hexane
75 The signal to noise ratio in the determination of LOD is _____.
a. 3:1
b. 5:1
c. 10:1
d. 15:1

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76 ____ is the closeness of agreement between a series of measurement obtained from
multiple sampling of same homogenous sample.
a. Accuracy
b. Precision
c. LOD
d. Linearity
77 In the qualification of UV-visible spectrophotometer, photometric accuracy is
determined using _______.
a. Potassium dichromate
b. Holmium perchlorate
c. Sodium iodide
d. Potassium chloride
78 Prospective validation is performed on atleast ______ successive batches.
a. Ten
b. Five
c. Three
d. Seven
79 __________ is carried out in connection with the introduction of new drug products.
a. Retrospective validation
b. Prospective validation
c. Concurrent validation
d. Revalidation
80 _________ is a process that demonstrates a particular instrument produces results
within specified limits, as compared to those produced by a traceable standard.
a. Validation
b. Qualification
c. Calibration
d. Verification

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Descriptive Questions:
Please note important points to be covered fin the answer are mentioned below the
question.

1 Enlist the ICH Q series guideline titles. Write in brief about Stability testing of
new drug substances.

(Ref: ICH guidelines Q1)

ICH Q series guidelines: Enlist no. and title of the guideline
Stability Testing of New Drug Substance:
No. of batches, Types of tests to be conducted, Frequency of Testing with conditions:
(For long term studies, accelerated storage, Intermediate storage condition),
Evaluation of Stability Data
2 Enlist the participants of ICH. Write in brief about photostability testing of drug
products.

Participants of ICH: Representatives from six parties, Additional members (non-

voting members)
Photostability testing of drug products (Ref: ICH guidelines Q1B):
Types of studies: exposed drug product, product in the immediate pack, drug product
in the marketing pack.
Light Source:
Procedure
Sample presentation
Evaluation
3 Define QbD. What are key elements of QbD? Differentiate between ISO 9000 &
ISO 14000.

Definition
Key Elements: Quality target product profile (QTPP), Critical quality attributes
(CQAs), Critical Process parameters, Design space
Differentiate between ISO 9000 & ISO 14000: Any 2 -3 points
4 Define TQM & write a note on elements and principles of TQM. Give the
process for NABL accreditation.

TQM: Definition as per any one of the philosophies

Elements & Principles: Focus on the Customer, Employee Total Involvement,
Continuous improvement
Briefly describe the philosophies by Deming, Juran, Feigenbaum, Philip Crosby
NABL accreditation: Process from application to issuance of certificate & renewal

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5 Define QbD. Write a note on tools of QbD. Explain the benefits and process of
ISO 9000 registration.

Define QbD
Tools of QbD: Design of Experiments, Risk Assessment, Process Analytical
Technology
Benefits of ISO
Process of ISO 9000 registration: All the steps
6 Define TQM & write a note on philosophies of TQM. Differentiate between
Quality Control & Quality Assurance.

Definition
Philosophies: Feigenbaum, Juran, Deming, Philip Crosby
Difference between QA & QC (any 4 points)
7 State the purpose of ICH. Write in brief about bracketing and matrixing design
for stability testing of new products.

Purpose of ICH
Bracketing and Matrixing (Ref: ICH guidelines Q1D): Reduced design, Definition of
bracketing, Application, Example – table, Definition of matrixing, Application,
Example – table
8 Define Quality Assurance. Give the importance of NABL accreditation and
explain the process of accreditation.

Definition
NABL: Advantages (any 4 points), Process from application to issuance of certificate
Renewal
9 What is Quality management System? Give the role of Quality Control and
Quality Assurance departments in a Pharmaceutical Industry

Quality management System – Definition, Elements of QMS

Functions of QC department & Functions of QA department
10 Discuss the key elements of QbD. What is ISO? Discuss its benefits and the
process of ISO registration.

Key Elements: Quality target product profile (QTPP), Critical quality attributes
(CQAs), Critical Process parameters, Design space
Explain ISO 9000, 14000, Benefits of ISO
Process of ISO 9000 registration – All steps

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11 What is NABL accreditation and its benefits? State the role of TQM in
pharmaceutical industry and discuss its philosophy.

NABL accreditation: Accreditation body, Purpose & advantages of accreditation

TQM – Advantages, Philosophies -Feigenbaum, Juran, Deming, Philip Crosby
12 What is Quality management system? Give the difference between QA & QC.

Definition, Relationship between QMS, QA, QC, GMP, Benefits of QMS

Difference (four points)
13 Discuss the training, hygiene and personal records with reference to GMP in a
pharmaceutical industry.

Ref: GMP schedule M

Types or training
Job responsibility
Health checks, Clothing, Personal hygiene
Disease reporting
Personal record and their purpose
14 Explain the process of equipment selection and maintenance in the
pharmaceutical manufacturing unit.

Criteria for equipment selection

Purchase specification
DQ, IQ, OQ, PQ
Periodic maintenance
Predictive maintenance
15 Write a note on utilities and maintenance of sterile areas. Illustrate a layout of
injection manufacturing unit.

Explain utilities (compressed air, gas, steam, heating, ventilation and air conditioning)
Control of utilities/periodic checks
Clean room classification
Control of clean room/Maintenance of sterile area (particle count, microbial
contamination, air pressure differentials)
Draw a layout mentioning class, air pressure / air flow, material entry, gowning area,
personal entry etc.
16 Explain in detail the equipment selection and maintenance of stores for raw
materials

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 Criteria for equipment selection: Purchase specification, DQ, IQ, OQ, PQ, Periodic
maintenance, Predictive maintenance
Maintenance of store for raw material: Layout & Storage, Receiving, Sampling,
Dispensing, Cleaning & sanitation
18 Explain the design and construction of building for a pharmaceutical
manufacturing unit.

(Ref: GMP schedule M)

Material of construction, Design & Layout, Measures to avoid cross contaminations
Sanitation & Cleaning, Drains & waste disposal, Environmental control measures
19 Discuss the process of equipment selection and its maintenance.

Criteria for equipment selection, Purchase specification, DQ, IQ, OQ, PQ

Periodic maintenance, Predictive maintenance
20 Write a note on maintenance of sterile area. Illustrate a layout for
manufacturing of injectables.

Clean room criteria, Maintenance/control measures & testing frequency,

Design/layout with reference to air flow and air pressure.
21. Write in brief about personal training. Discuss the responsibilities of key
personnel.

Types of training
Responsibilities of Head of Production, QA & QC
22 What is the role of Quality Assurance Unit in a testing facility? Write in brief
about animal care for conduct of nonclinical study.

Role of Quality Assurance Unit: Responsible for monitoring each study to assure
management that the facilities, equipment, personnel, methods, practices, records, and
controls are in conformance with the regulations in this part.
Animal care: (Ref: 21 CFR GLP Subpart C & subpart E): Animal housing, Health
Cleaning, Sanitization, Pest Control, Labelling & Identification of animals,
Documentation – Diagnosis, treatment, date, health record, Feed, water, bedding
23 Define GLP. Write in brief about disqualification of testing facility.

Definition: As per OECD

Disqualification of testing facility (Ref: 21 CFR GLP subpart K): Grounds for
disqualification, Notice and Opportunity for Hearing on Proposed Disqualification,
Final Order, Actions upon disqualification

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24 Enlist the quality control tests for glass containers. Write in brief about
powdered glass test.

Quality control tests for glass containers: Hydrolytic Resistance Test, Surface Test
Water Attack Test, Powdered Glass Test, Light Transmission Test, Arsenic Test etc.
Powdered glass test: Purpose, Procedure, Limits
25 Enlist the quality control tests for glass containers. Discuss in brief the
hydrolytic resistance test.

Enlist the Quality control tests for glass containers

Hydrolytic resistance test: Purpose, Process, Limits & Surface test
26 Explain in brief quality control test for metal containers used for eye ointment.

(Refer IP): Enlist the tests, Procedure, Limits

27 Write a note on quality control tests for secondary packaging.

Enlist, brief tests for paper & paperboard

28 Define GLP. Discuss in brief the protocol for conduct of nonclinical study.

Definition as per OECD

Protocol for conduct of nonclinical laboratory tests (Ref 21 CFR GLP subpart G)
Every study – approved protocol
Contents of protocol
All changes in or revisions of an approved protocol and the reasons therefore shall be
documented, signed by the study director, dated, and maintained with the protocol
29 Discuss the quality control tests for plastic containers.

Enlist the tests, Procedure for each test with limit

30 Discuss the QC tests for rubber closures

Enlist, Procedure, Limit for all tests

31 What is Complaint? Discuss the steps involved in handling of complaints in a
pharmaceutical company.

Definition, Types, Steps for handling of complaints – Receipt to monthly trend

analysis
32 What is product quality review? Discuss “Quality audit” in pharmaceutical
industry.

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 Product Quality Review: Definition, Purpose
Quality audit: Definition, Types, Objectives, Principles
33 Discuss Quality Review and Quality documentation in pharmaceutical industry.

Quality Review: Definition, Objective, Process/Phases

Quality Documentation: Write about each tier of documentation
34 Define SOP. Discuss the general format of SOP

Definition
General Format of SOP: Header, Footer, Validity, Contents, Signatures &
Authorizations
Illustrate Sample SOP
35 Explain the process of recall. Write a note on disposal of waste in
pharmaceutical industry.

Recall types, Recall process

Disposal of waste: Types of waste, Different process of disposal
36 Enlist the types of documents maintained in pharmaceutical company. Write in
brief about batch formula record.

Ref: Pharmaceutical Quality Assurance by Manohar Potdar

Types of documents (enlist any 4-8)
Batch Formula record: Contents, Sample batch record
37 Define SOP. Explain the general format of SOP and its implementation.

Definition
Contents – Company name and pagination, Title, Identification, Effective Date,
Review Period/Validity, Scope, Responsibility, Procedure, Review and approval
Implementation – Training & distribution
38 What is recall? Explain in detail the process for handling of complaints.

Definition of recall, Enlist types of recall, Steps – Handling of complaints

39 State the purpose of distribution records. Write a note on Master Formula
Record.

Purpose
Master Formula Record – Definition, Purpose, Contents, Sample format

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40 What is recall and returned product? Write in brief about handling of
complaints.

Definition recall
Explain returned product
Complaint handling steps
41 Write a note on handling of returned goods. Discuss the disposal of waste in
pharmaceutical industry

Explain Returned goods, handling, documentation

Disposal of waste – discuss different methods
42 Define Validation. Give the process for qualification of UV-visible
spectrophotometer.

Definition
Qualification of UV-visible spectrophotometer: (Ref USP/IP)
Write in detail about the reference/standards used and acceptance criteria for
following tests: Control of Wavelength, Limit of Stray light, Resolution, Control of
Absorbance
43 What are good warehousing practices? Write a note on material management.

Good warehousing practices: Layout & segregation, Sanitation, Control of stock

Documentation, Maintenance of stock – system, Identification & labelling,
Warehouse staff and access to warehouse
Material Management: Planning and procuring materials, Vendor selection,
Purchasing, Receipt of materials (including sampling for quality control), Inventory
management, Dispensing of materials.
44 Enlist the types of process validation. Explain the process for calibration of pH
meter.

Types of Process validation: Prospective validation, Retrospective validation

Concurrent validation
Process of calibration of pH meter: Three point or two-point calibration, Buffers used,
Electrode care & storage
45 State the importance of inventory management. Discuss the Good warehousing
practices in detail.

Inventory management: List advantages of inventory control

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 Good warehousing practices: Layout & segregation, Sanitation, Control of stock,
Documentation, Maintenance of stock – system, Identification & labelling,
Warehouse staff and access to warehouse
46 Define validation. Explain in brief the types of process validation.

Definition, Prospective validation, Retrospective validation, Concurrent validation

Revalidation
47 Explain in brief the objectives and elements of material management.

Material Management: Benefits & Purpose, Planning and procuring materials,

Vendor selection, Purchasing, Receipt of materials (including sampling for quality
control), Inventory management methods, Dispensing of materials.
48 Define validation. Write a note on analytical method validation

Ref: ICH Q2 R guidelines

Definition
Analytical method validation – Accuracy, precision, LOD, LOQ, Linearity & Range,
Robustness
49 Define validation. Give the difference between validation & calibration. Write a
note on prospective validation.

Definition, Difference (2 points), Prospective validation – purpose, no. of batches

studied, process.
50 Write the difference between Prospective, Concurrent & retrospective
validation. Discuss calibration of pH meter

Difference (two points)

Calibration: three-point method

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