INDUSTRIAL PHARMACY-II (BP702TT)
Assignment 2
MCQ
Industrial Pharmacy-II
(BP702TT)
Name of Student: Ravirajsinh Hardevsinh Gohil
Enrollment No.: 172870290011
1) Following are facts about technology transfer in pharmaceutical industry except
a. Government labs to private sector firms.
b. private sector firms of same country.
c. private sector firms of different country.
d. private sector firm to academia
Ans : D
2) What are the reasons behind the technology transfer in pharmaceutical industry?
a. Due to lack of manufacturing capacity
b. Exploitation in different field of application
c. to lack of resources to launch product commercially
d. All of the above
Ans: D
3) Process of technology transfer is primarily devided in to how many phases?
a. 1
b. 2
c. 3
d. 4
Ans: C
4) Which of the following is a phase of technology transfer process is considered as a last phase?
a. Development phase
b. Production phase
c. Research phase
d. Quality testing phase
Ans : B
5) Master formula card consist of ?
a. Product strength
b. Generic name
c. MFC number
d. All of the above
Ans: D
6) Master formula card include following except?
a. Product name
b. Stability profile of drug
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INDUSTRIAL PHARMACY-II (BP702TT)
c. Generic name
d. Effective date
Ans : B
7) The technology transfer team consist of ?
a. QA technologist
b. Production representative
c. Both A and C
d. None of these
Ans : C
8) Which of the following is the responsibility of process technologist during technology
transfer?
a. Reviews documentation to determine compliance with marketing authorization (MA).
b. Reviews analytical methods with QC to determine capability, equipment training
requirements.
c. conversion of donor site documentation into local systems or format.
d. Collect documents from donor site
Ans : D
9) Following are the responsibilities of the QC representative except?
a. Consider impact on local standard operating procedure.
b. Reviews analytical requirement
c. Availability with instruments.
d. Responsible for analytical method transfer for drug substance and drug product
Ans : A
10) Generally which kinds of problems are associated with technology transfer in pharmaceutical
industry?
a. Transferror does not fully understand transferre needs.
b. Inadequate tracking of technology during implementation.
c. Lack of trust between transferor and transferee.
d. All of the above
Ans : D
11) The success of technology transfer in pharmaceutical industry depends upon following factors
except?
a. Open communication between all team members.
b. Direct communication between technical members
c. Technology transfer is a one way process
d. Teamwork at all time
Ans : C
12) There are how many principles of quality risk management?
a. 1
b. 2
c. 3
d. 4
Ans : B
13) There are how many steps in process of quality risk management?
a. 5
b. 6
c. 7
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INDUSTRIAL PHARMACY-II (BP702TT)
d. 8
Ans : A
14) According to ICH which guideline is given for quality risk management in pharmaceutical
industries?
a. Q6
b. Q8
c. Q7
d. Q9
Ans : D
15) It is the qualitative or quantitative process of linking the likelihood of occurrence and severity
of harms is called?
a. Risk identification
b. Risk analysis
c. Risk evaluation
d. Risk control
Ans : B
16) Risk control might be focus on which parameters?
a. What can be done to reduce or eliminate risks?
b. What is the appropriate balance among benefits, risks and resources?
c. Are new risks introduced as a result of the identified risks being controlled
d. All of the above
Ans : D
17) A systematic process for the assessment, control, communication, and review of risks to the quality of
the drug product across the product lifecycle is known as?
a. Quality system
b. Quality risk management
c. Risk acceptance
d. Risk assessment
Ans : B
18) HACCP consist of how many steps?
a. 5
b. 6
c. 7
d. 8
Ans : C
19) Which of the following is not meaning of risk?
a. Risk is a cognitive and emotional response to expected loss.
b. Risk is a societal expression of expected harm tempered by expected benefits.
c. Risk is usually based on the expected value of the conditional probability of the event occurring
times the consequence of the event given that it has occurred.
d. Risk is situation which places an individual's life or health in immediate jeopardy.
Ans : D
20) Which of the following is the most difficult area in technology transfer in pharmaceutical industry?
a. Pricing
b. Publicity
c. Paper work
d. People's acceptance
Ans : A
21) The institute which is not associated with providing assistance in technology transfer in pharmaceutical
industry?
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INDUSTRIAL PHARMACY-II (BP702TT)
a. Technology bureau for small Enterprise(TBSE)
b. Asia Pacific centre for transfer of technology (APCTT)
c. Indian institute of technology Bombay (IITM)
d. National research and development corporation
Ans : C
22) Following are the approaches to overcome barriers in technology transfer except?
a. Commercializing publicly funded technologies
b. Web access and scientific publication
c. Inadequate funding in important areas and possible treaties
d. Improper treaty on scientific access
Ans : D
23) Following are the approaches to overcome barriers in technology transfer in pharmaceutical industry?
a. Research tool patent and freedom to operate for the public sector.
b. Web access and scientific publication
c. Proper treaty on scientific access
d. All of the above
Ans : D
24) Master packaging card gives information about?
a. Strength
b. Generic name
c. Stability profile
d. MFC number
Ans : C
25) Technology transfer checklist consists of?
a. Dispensing instructions
b. Analytical methods
c. Packaging instructions
d. All of the above
Ans : D
26) Problem in tablet are either related imperfections is due to which factor during technology transfer?
a. Tableting process
b. Excipients
c. Machines
d. Any of the above
Ans : D
27) As a part of development whaich of the following is not considered as a purpose of quality risk
management?
a. To design a quality product and its manufacturing process to consistently deliver the intended
performance of the product.
b. To assess the critical attributes of raw materials, solvents, active pharmaceutical ingredient (API)
starting materials, APIs, excipients, or packaging materials
c. To increase variability of quality attributes
d. To establish appropriate specifications, identify critical process parameters, and establish
manufacturing controls
Ans : C
28) Which annexure provides examples of situations in which the use of the quality risk management process
might provide information that could then be used in a variety of pharmaceutical operations?
a. Annexure I
b. Annexure II
c. Both of the above
d. None of these
Ans : B
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INDUSTRIAL PHARMACY-II (BP702TT)
29) Following are the supporting tools for the process of quality risk management?
a. Histogram
b. Pareto charts
c. Process capability analysis
d. All of the above
Ans : D
30) The technology transfer protocol is prepared by integrated inter-disciplinary team of cross functional
experts from______?
a. Research and development department
b. National institute of pharmaceutical research and organisation
c. QA & QC department
d. A and C both
Ans : d
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