Shivaji University, Kolhapur

Question Bank for March 2022 (Summer) Examination

Subject Code: 80897 Subject Name: Industrial Pharmacy-II

OBJECTIVE TYPE QUESTIONS (02 Marks)

1. What is pilot plant?

2. What do you mean by SUPAC?
3. Give difference between pilot scale sand scale up.
4. Mention the benefits of platform technology.
5. What are the current requirements of post approval changes?
6. Give the reasons to conduct pilot plant studies.
7. What are the objectives of scale up?
8. Define platform technology.
9. What is the purpose of SUPAC guidelines?
10. What do you mean by GMP and cGMP?
11. Enumerate various aspects of pilot plant operation.
12. Mention four areas in which training of pilot plant can be calculated.
13. Define technology transfer according to WHO.
14. What are the goals of technology transfer?
15. Give advantages of technology transfer.
16. Highlight constituents of technology transfer.
17. What do you mean by receiving unit (RU) and sending unit (SU)
18. Define quality risk management.
19. Give the meaning of process validation.
20. What is validation protocol and validation report?
21. What do you mean by FMECA?
22. Give the meaning of drug master file.
23. What do you mean by analytical method transfer?
24. What is design qualification and installation qualification?
25. Give the difference between NDA and ANDA.
26. What is operational qualification and performance qualification?
27. What is regulatory affairs?
28. Enumerate parameters of drug regulatory affairs.
29. Mention non clinical regulatory guidelines.
30. Highlight sections contained in INDs.
31. What do you mean by clinical trial?
32. What is clinical trial protocol?
33. What is drug master file?
34. What is orange book?
35. Summarize the concept of quality management system.
36. Enumerate steps to implement an effective quality management system.
37. What do you mean by quality in pharmaceutical industry?
38. Give the importance of quality.
39. What is analytical method transfer?
40. What are the objectives of TQM?
41. Enlist various characteristics of TQM.
42. Mention major regulatory bodies in the world.
43. What are the advantages of TQM?
44. What are the disadvantages of TQM?
45. Give the meaning of Quality by design.
46. What is the main objective of Quality by design?
47. Mention the benefits of Quality by design.
48. Mention the benefits of Quality by design to industry.
49. Mention the benefits of Quality by design to FDA.
50. Mention ICH guidelines of Quality by design foundation.
51. Enumerate various softwares used for six sigma.
52. What are the phases of investigating out of specification?
53. What is the impact of out of specification on regulatory?
54. What is NABL accreditation?
55. What is six sigma?
56. What do you mean by process analytical technology?
57. What are the benefits of NABL accreditation?
58. Write vision and mission of CDSCO.
59. What are the different types of certificate of pharmaceutical products?
60. What are the types of drugs for which certificate of pharmaceutical products may be
issued?
61. Who can apply for certificate of pharmaceutical products?
62. How to obtain certificate of pharmaceutical products?
63. Mention different phases of clinical trial.
64. Enumerate the names of laboratories of CDSCO.
65. Define Indian pharmacopoeial commission.

SHORT ANSWER QUESTIONS (05 Marks)

1. What are the objectives and significance of pilot plant?

2. Discuss about WHO guidelines for technology transfer.
3. What is the importance of platform technology?
4. Give schematic presentation of various steps in scale up.
5. Describe unique operational aspects of pilot plant.
6. Explain different level of changes according to SUPAC.
7. What are the types of INDs?
8. Give classification of drugs in NDA. Highlight fundamentals of NDA submission.
9. What is the general requirement for filing NDA?
10. Explain technology transfer sample protocol in pharmaceuticals.
11. Discuss technology transfer from R & D to production as per WHO guidelines.
12. Discuss documentation, premises and equipments for technology transfer as per
WHO guidelines.
13. Discuss qualification and validation for technology transfer as per WHO guidelines.
14. How analytical methods are exchanged in a technology transfer?
15. Write a note on Quality Assurance and Quality control activities in pilot plant
operation.
16. Elaborate different problems in technology transfer.
17. What is technology transfer? Write factors that affects the process of technology
transfer in pharmaceutical industry.
18. Discuss about various technology transfer agencies in India.
19. Discuss role and responsibilities of RA professionals.
20. Elaborate various phases of drug development and drug approval process.
21. How to design clinical research protocol?
22. Discuss comparison between traditional approach and TQM in terms of different
elements.
23. Describe key elements of TQM.
24. What is the importance of TQM in pharmaceutical industry?
25. What are the key elements of QbD? How to implement it?
26. Describe various tools used for QbD.
27. Elaborate six sigma methodologies.
28. What is ISO? Write its aim and objectives. Enlist common challenges faced by ISO.
29. Summarize various steps of ISO registration. What are the key elements of ISO
9000 series?
30. Write a note on NABL accreditation process.
31. What is GLP? Give its objectives and the reasons of GLP creation?
32. Write process and benefits of change control system.
33. What is ISO 14000? Give its objectives. Highlight reasons to adopt ISO 14000.
34. Explain PDCA cycle for ISO 14001.
35. What are the principles of GLP?
36. Discuss Central Drug Laboratory under CDSCO alongwith its functions.
37. Illustrate with the help of flow diagram process of NDA approval.
38. Write a note on ICH guidelines.
39. Explain the features of finished product technology transfer as per WHO guidelines.
40. Discuss responsibilities and functions of CDSCO.
41. Discuss about regulatory requirements and approval procedures for New Drugs.
42. Elaborate the process of drug approval in India.
43. Give the organizational structure of state licensing authority alongwith
responsibilities and functions of state drug control organization.
44. What is investigators brochure? Comment on its content.
45. What is GMP? Write basic outline of GMP.

LONG ANSWER QUESTIONS (10 Marks)

1. Demonstrate and discuss pilot plant scale up considerations for solid.

2. Demonstrate and discuss pilot plant scale up considerations for semisolid.
3. Demonstrate and discuss pilot plant scale up considerations for liquid orals.
4. What are the general considerations during pilot plant scale up?
5. What are the guidelines available for ANDA?
6. What is platform technology? What are the pathways for its development?
7. What is the importance and constituent of Technology transfer?
8. What are ICH guidelines? Write role of ICH guidelines in technology transfer.
9. Elaborate the role of biostatistics in pharmaceutical product development. How it
will help in drug development and manufacturing process.
10. What are the different types of clinical research? Write a note on BE study design.
11. What is clinical trial management system? Write its purpose and functions.
12. What are the tools, regulations, guidelines and standards in clinical data
management system?
13. Discuss in details various technology transfer agencies in India.
14. Describe granularity of technology process in the form of API, excipients, finished
products and packaging materials.
15. What is ISO 14000? Enlist various standards of ISO 14000 based on organization
and product. Write its principles and benefits.