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Industrial Pharmacy II BP702T MCQs With Answers

Industrial Pharmacy II BP702T

Semester VII Semester

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

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
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

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

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

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