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INDUSTRIAL PHARMACY II (BP702T) IMP QUESTIONS B-PHARMACY 7th SEMESTER

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INDUSTRIAL PHARMACY II (BP702T)
IMP QUESTIONS
B-PHARMACY 7th SEMESTER
1). What is Pilot plant scale up techniques? Write its objectives and importance.
2). Write a note on SUPAC guidelines.
3). Write a note on Platform- Technology.
4). Define the term TT. Write a note on technology transfer from R&D to Production
area.
5). Technology transfer agencies in India. Write a short note on role of TT agencies.
6). Definition of TT Documentation. Write a short note on practical aspects and case
studies of technology transfer.
7). Define Technology transfer protocols and write about WHO guidelines of TT.
8). Define the term Regulatory Affairs Authorities. Write the role of Regulatory affairs
authorities in pharmaceutical industry.
9). What is IND? Write a detailed note on New Drug Application (NDA).
10). Define drug development team. Write about role of biostatics n pharmaceutical
product.
11). Write a short note on Regulatory Requirement and approval procedures for new
drugs.
12). Definition of Quality Management. Write a note on Total Quality Management
(TQM).
13). Write a note on ISO 14000.
14). Note on CDSCO.
15). Write a short note on: (A) QbD (B) NABL (C) GLP (D) SNA
16). Write the role of regulatory requirements and approval procedure for new drugs.
17). Short note on COPP.
18). Explain Organization and Responsibilities of State Licensing Authority in India.
19). Write a note on clinical and Non clinical research protocol.

20). What is:
(A) Six Sigma Concept
(B) Out of Specification (OOS).
(C) Change Control
Note: –
• 1 to 15 Most IMP
• 15 to 20 Extra for Toppers

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