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

Binding to die walls can also be overcome by designing the die to be inch wider
2.
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

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

1
Full form of HVAC
0.

A Heating, ventilation, and air cooling

B Heat, ventilation, and air conditioning

C Heating, ventilation, and air conditioning

D None of above

1
APCTT Was established in
1.

A Pune

B Delhi

C Geneva

D Bangalore

1
DIB stands for
2.

A Drug information board

B Drug investigational board

C Drug information branch

D None of above

1
In NDA Classification of drugs is done in
3.
 A 7 class

B 5 class

C 6 class

D 4 class

1
ANDA takes
4.

A 2-5 years

B 5-10 years

C 1-2 years

D 5-8 years

1
There are ….. Phases of clinical trials
5.

A 4

B 3

C 2

D 5

1
Food, drug and cosmetic act (FD&C Act)comes in
6.

A Since 1938

B since 1945

C since 1935

D since 1940

1
Kefauver-Harris Amendments to the FD & C Act comes in
7.
 A 1956

B 1968

C 1972

D 1962

1
CoPP format is recommended by the
8.

A GMP

B FDA

C WHO

D all of the above

1
pilot CoPP is issued by
9

A GMP

B U S FDA

C WHO

D CDSCO

2
NDA Can consist of as many as ……. Sections.
0.

A 17

B 16

C 15

D 13

2
Which of following is certification system for laboratory accreditation?
1.
 A ISO

B WHO

C NABL

D GMP

2
. --------Guideline of ICH describes Quality management system
2.

A ICH Q8

B ICH Q9

C ICH Q10

D ICH Q11

2
The words Quality comes from
3.

A Latin word

B English word

C Greek words

D Sanskrit words

2
What Is The Meaning Of User Based Quality?
4.

A fitness for use

B at right time

C accurate measurement

D right quality for use

2
Who gave definition of quality?
5.
 A Joseph M. JURAN

B Philip Crosby

C John Ruskin

D Armand Feigenbaum

2
Who is the father of quality evaluation?
6.

A Dr. W Edward Deming

B John Ruskin

C Armand Feigenbaum

D Joseph M. Juran

2
TQM is ______ oriented system.
7.

A personal

B method

C system

D procedure

2
the drug and cosmetic act comes on
8.

A 1940

B 1950

C 1955

D 1960

2
the headqoter of CDSCO is located at
9.
 A New Delhi

B Kolkata

C MUMBAI

D Chennai

3
Which one is not the zonal office o0f CDSCO.
0.

A Bangalore

B Kolkata

C Mumbai

D Chennai

3
sub zonal office of CDSCO
1.

A Goa

B Indoor

C Varanasi

D All Of The Above

3
Central drug laboratory of CDSCO is situated at.
2.

A kasauli

B Kolkata

C both A and B

D Chennai

3
Price charged for a technology should depend upon following:
3.
 A Technology

B High profit

C Research cost

D Market force

3
Research phase of technology transfer involves:
4.

A Design of procedure

B Selection of excipients

C identification of excipients

D All of above

3
Colored Ribbon Is Design dated The
5.

A Certificate of COPP

B color of COPP

C Type Of COPP

D None of the above

3
For easy handling order which system should be followed?
6.

A LIFO

B FIFO

C Above both

D None of above

3
State the other name of dry granulation?
7.
 A Mixing

B Reduction

C Slugging

D Blending

3 Which of the following is not a part of space requirement in general consideration

8. of pilot plant?

A Physical testing area

B Standard equipment floor space

C Storage area

D Raw material

3
What the term scale up means:
9.

A Increasing batch size

B Decreasing batch size

C Increasing production rate

D Increasing quality of batch

4
What the term scale down means:
0.

A Increasing batch size

B Decreasing batch size

C Increasing production rate

D Increasing quality of batch

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

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

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

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

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.
.

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