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Industrial Pharmacy

This document contains questions related to four units of the course "Industrial Pharmacy -II". Unit 1 focuses on pilot plant studies, including objectives of pilot plants, GMP considerations, and scale-up approaches for different dosage forms. Unit 2 covers technology transfer guidelines, processes, documentation, and analytical method transfers. Unit 3 is about regulatory affairs, including the roles and responsibilities of regulatory professionals, the drug development and approval process, and clinical trial requirements. Unit 4 provides short questions on quality management approaches like TQM, QbD, and GLP. Unit 5 asks about regulatory bodies like CDSCO and ISO in India as well as biostatistics and state licensing.

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49 views3 pages

Industrial Pharmacy

This document contains questions related to four units of the course "Industrial Pharmacy -II". Unit 1 focuses on pilot plant studies, including objectives of pilot plants, GMP considerations, and scale-up approaches for different dosage forms. Unit 2 covers technology transfer guidelines, processes, documentation, and analytical method transfers. Unit 3 is about regulatory affairs, including the roles and responsibilities of regulatory professionals, the drug development and approval process, and clinical trial requirements. Unit 4 provides short questions on quality management approaches like TQM, QbD, and GLP. Unit 5 asks about regulatory bodies like CDSCO and ISO in India as well as biostatistics and state licensing.

Uploaded by

Ankan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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INDUSTRIAL PHARMACY -II

QUESTIONS FOR SMESTER


Unit -1
1) What is pilot plant and it’s objectives?
2) General consideration / Requirements During pilot plant.
3) Need pilot plant studies ?
4) State drug control organization?
5) GMP consideration and it’s advantages or disadvantages?
6) Objectives of scale up ?
7) Pilot plant design for tablet?
8) Pilot plant design for capsules?
9) Semi solid dosage form and its parameters?
10) Explain the pilot plant scale up considerations for liquid orals?
11) SUPAC guidelines.

Unit -2

12) Who guidelines for Technology Transfer ?


13) Different terminology for Technology Transfer?
14) Give a brief account on Technology transfers protocol?
15) Ouality Risk Management?
16) Discuss technology Transfer from R & D Production as
per who guidelins for TT ?
17) Information required for TT process?
18) Quality control?
19) Qualification and Validation?
20) What is Good Manufacturing Practices?
21) What do you mean by SU & RU?
22) What do you mean by intercompany & intracompany?
23) What is standard operating Process validation?
24) What is validation protocol & validation report?
25) What is Drug master file?
26) What is analytical method transfer?
27) What is Design qualification & installation qualification?
28) Discuss stage involved in TT in pharmaceutical industry?
29) Discuss about documentation, premises, and
equipments for TT as per WHO guidelines
30) How analytical methods are exchanged in a technology
transfer ?

Unit -3

31) Regulatory Affairs?


32) Role of Regulatory Affairs Department?
33) what is investigational new drug and application?
34) what is New drug application (NDA) ?
35) what is clinical trial?
36) what is clinical trial protocol?
37) what are BE & BA studies? why they are required?
38) Mention the major regulatory bodies in the world?
39) What is the organisational structure of regulatory affairs
?
40) Which is the health care product regulated by RA ?
41) What is CTD ?
42) Discuss the role and responsibilities of RA professional?
43) Write a note on Drug development team and their
functions?
44) Discuss regulatory authorities and their responsibilities?
45) Write a note on Non-clinical drug development process?
46) Write a note on Investigator’s Brochure (IB)?
47) Discuss the different phase of clinical trial?
48) How Bioequivalence are documented?
49) Write a note on clinical Research protocol?
50) Discuss about Management of clinical studies?
51) Discuss the various Modules in CTD?
52) Explain Regulatory Requirement Approval for obtaining
NDA?
53) Discuss general consideration of Investigational New
drug Application?

Unit -4

54) Write a short note on TQM?


55) Write a short note on QBD?
56) Write s short note on Six Sigma?
57) Write a short note on GLP?

Unit -5

58) Explain about CDSCO?


59) Summarize the biostatistics in pharmaceutical product
development?
60) Describe about the responsibilities of state licensing authority?
61) What is ISO 9000?
62) Role of ISO in pharmaceutical Industry?
63) What was given in the CDSCO regarding academic Research?

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