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MCQ-30 - Short questions for practice the subject knowledge.

Industrial Pharmacy II (Saurashtra University)

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Industrial Pharmacy II BP702T

Semester VII Semester
MODEL QUESTION BANK

1. Technology transfer is
A Purpose-oriented
B Process- oriented
C Technology- oriented
D Commercial- oriented
2. Binding to die walls can also be overcome by designing the die to be inch
wider the upper than at the centre in order to relieve pressure during
ejection.
A 0.001 to 0.005
B 0.01 to 0.05
C 0.001 to 0.05
D 0.01 to 0.005
3. Parameter to be considered for scale up of Fluidized bed dryer
A Optimum load
B Air flow rate
C Inlet air temperature and humidity of the incoming air
D All of above
4. NDA takes
A 12 years
B 15 years
C 10 years
D 5 years
5. Types of TT involves
A Vertical
B Horizontal
C A & b BOTH
D None
6. Design space includes
A Variables and process parameters
B Attributes
C DMF

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D Process parameters
7. Identification of critical elements of a process is also known as
A Design space
B Gap analysis
C IPQC
D Acceptance criteria
8. Which of the following guideline provides principles for QRM ?
A Q8
B Q9
C Q10
D Q11
9. The art of designing of prototype using the data obtained from the pilot
plant model
A Scaling
B Art work
C Scale up
D Model design
10. Full form of HVAC
A Heating, ventilation, and air cooling
B Heat, ventilation, and air conditioning
C Heating, ventilation, and air conditioning
D None of above
11. APCTT Was established in
A Pune
B Delhi
C Geneva
D Bangalore
12. DIB stands for
A Drug information board
B Drug investigational board
C Drug information branch
D None of above
13. In NDA Classification of drugs is done in
A 7 class
B 5 class
C 6 class

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D 4 class
14. ANDA takes
A 2-5 years
B 5-10 years
C 1-2 years
D 5-8 years
15. There are ….. Phases of clinical trials
A 4
B 3
C 2
D 5
16. Food, drug and cosmetic act (FD&C Act)comes in
A Since 1938
B since 1945
C since 1935
D since 1940
17. Kefauver-Harris Amendments to the FD & C Act comes in
A 1956
B 1968
C 1972
D 1962
18. CoPP format is recommended by the
A GMP
B FDA
C WHO
D all of the above
19 pilot CoPP is issued by
A GMP
B U S FDA
C WHO
D CDSCO
20. NDA Can consist of as many as ……. Sections.
A 17
B 16
C 15
D 13

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21. Which of following is certification system for laboratory accreditation?

A ISO
B WHO
C NABL
D GMP
22. . -------- Guideline of ICH describes Quality management system
A ICH Q8
B ICH Q9
C ICH Q10
D ICH Q11
23. The words Quality comes from
A Latin word
B English word
C Greek words
D Sanskrit words
24. What Is The Meaning Of User Based Quality?
A fitness for use
B at right time
C accurate measurement
D right quality for use
25. Who gave definition of quality?
A Joseph M. JURAN
B Philip Crosby
C John Ruskin
D Armand Feigenbaum
26. Who is the father of quality evaluation?
A Dr. W Edward Deming
B John Ruskin
C Armand Feigenbaum
D Joseph M. Juran
27. TQM is ______ oriented system.
A personal
B method
C system
D procedure
28. the drug and cosmetic act comes on

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A 1940
B 1950
C 1955
D 1960
29. the headqoter of CDSCO is located at
A New Delhi
B Kolkata
C MUMBAI
D Chennai
30. Which one is not the zonal office o0f CDSCO.
A Bangalore
B Kolkata
C Mumbai
D Chennai
31. sub zonal office of CDSCO
A Goa
B Indoor
C Varanasi
D All Of The Above
32. Central drug laboratory of CDSCO is situated at.
A kasauli
B Kolkata
C both A and B
D Chennai
33. Price charged for a technology should depend upon following:
A Technology
B High profit
C Research cost
D Market force
34. Research phase of technology transfer involves:
A Design of procedure
B Selection of excipients
C identification of excipients
D All of above
35. Colored Ribbon Is Design dated The
A Certificate of COPP

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B color of COPP
C Type Of COPP
D None of the above
36. For easy handling order which system should be followed?
A LIFO
B FIFO
C Above both
D None of above
37. State the other name of dry granulation?
A Mixing
B Reduction
C Slugging
D Blending
38. Which of the following is not a part of space requirement in general
consideration of pilot plant?
A Physical testing area
B Standard equipment floor space
C Storage area
D Raw material
39. What the term scale up means:
A Increasing batch size
B Decreasing batch size
C Increasing production rate
D Increasing quality of batch
40. What the term scale down means:
A Increasing batch size
B Decreasing batch size
C Increasing production rate
D Increasing quality of batch

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41 Factories act comes on

A 1948
B 1945
C 1940
D 1943
42. Rules and guidelines for regulation of drugs in India are:
A ICMR guideline
B schedule Y guideline
C ICH GCP guideline
D All of the above
43. Which of the following is part of pilot plant operation?
A validation
B training
C process and manufacturing activity
D all of the above
44. Which of the following not a part of process evaluation in pilot plant
operation?
A Raw Material
B Mixing Speed
C Mixing Time
D Heating And Cooling Rates.
45. Empty gelatin capsule have recommended storage condition at:
A 15 to 25 0C
B 05to 25 0C
C 15 to 35 0C
D 05 to 10 0C
46. Addition and dispersion of suspending agent in lab scale is known as:
A Sprinkling Method
B Shaking Method
C Suspending Method
D Addition Method
47. Rules or concepts governing the operation of the system is
A Operating Principal
B Operating Procedure
C Operating Scale
D Operating Program
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48. For which level changes being effected supplement or prior approval
supplement are filed according to SUPAC
A Level1
B Level 2
C Both Of Above
D None
49. Drug development team connects with?
A global regulatory affaire
B scientific affairs
C clinical development
D all of the above
50. Non-clinical development is known as?
A post clinical development
B clinical development
C pre-clinical development
D None of the above
51. For which level prior approval supplement are filed according to SUPAC
A Level 1
B Level2
C Level 3
D None
52. Level 2 changes vary depending on which factor:
A Therapeutic Range
B Solubility
C Permeability
D All Of The Above
53 What is the British technology group ?
A combination of NRDC with TIFAC
B combination NRDC with NEB
C combination ESCAP with BTG
D combination of APCTT with SME
54. Quality information of drug submission for new drug approval includes
A control of drug product
B .characterization
C drug substance
D all of the above

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55. Requirement for permission of new drug approval ,CTD has

A .5 stage
B .4srage
C .3 stage
D 2 stage
56. Full form of FAT is……
A Factory Acceptance Test
B Formulation Acceptance Test
C Factory Achieved Test
D None
57 CQAs are generally associated with……..
A Process Methodology
B Drug Substance
C Quality Management
D Drug Profile
58. Which ISO series is a management tool to improve the environmental
performance of the organization
A ISO9001
B ISO14000
C ISO 15000
D ISO 45001
59. Confidentially agreement can be……
A One Way
B Two Way
C Both Way
D None
60. ____no of studies performed in non-clinical drug development
A .2
B .5
C .3
D .4
61. In transfer process their presence of …
A Receiving Unit
B Sending Unit
C Unit Manufacturing Process
D All of the above

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62. For the assay of potency how much replicate test per site should be
performed?
A 12
B 10
C 18
D 20
63. Relevant document for equipment include……
A Drawing
B Standard Operating Procedure
C Manual
D All of the above
64. Name of regulatory of USA?
A FDA
B CDSCO
C TGA
D MHRA
65. Material attributes and process parameter are crucial part of………
A Design Of Experiment
B PAT
C Risk Management Methodology
D Preliminary Hazard Analysis
66. WTO stands for
A World Trade Organization
B World Teaching Organization
C Work Trade Office
D None of The Above
67. Full form of ICH
A Indian Conference on Harmonization
B International Conference of Harmonization
C International Conference on Harmonization
D International committee On Harmonization
68. _______is the regulatory authority of India.
A EMEA
B CDSCO
C MPA
D .MHRA

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69. The main focus on QbD is in …..

A Reproducibility
B Quality Assurance
C Robustness
D Quality Management
70. The clinical trials were further divided into two categories in.
A 2006
B 2003
C 2007
D .2008
71. Which of the following is CPP for small molecule?
A Temperature
B Feed Type And Rate
C Dissolved Oxygen
D Medium Constitute
72. Six sigma equals ____________%accuracy
A 99
B 97.99
C 99.79
D 99.99
73. _______is the first company to developed the six sigma methodology.
A Sci Test Lab
B Motorola
C Hyundai
D Atos
74. The Phase I of OOS include ……..
A Laboratory Investigation
B Full Scale Investigation
C Clinical Investigation
D Animal Care Investigating
75. Act for narcotic drug and psychotropic substances comes on
A 1981
B 1982
C 1983
D 1985
76. Act for drug price control order come on.

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A 1992
B 1995
C 1993
D 1998
77. . Technology vision 20354 was released by__
A Shri Narendra Modi
B Dr. A P J Abdul Kalam
C TIFAC
D .NRDC
78. TBSE is a result of the cooperative initiative of ……
A .APCTT, SIDBI and SSI
B TIFAC and SIDBI
C APCTT and SSI
D NRDC and APCTT
70. Parameter of drug regulatory affaire?
A Design
B National Laws
C Construction
D All of The Above
80. In drug development NDA is.
A New Drug Application
B New Dose Application
C National Drug Application
D None Of The Above
81. MFC stand for
A Master Formality Card
B Master Formula Card
C Manufacturing Formula Card
D Management Formula Card

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