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
