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| Industrial pharmacy 2 most imp que |
1. What is pilot plant scale up? Discuss the significance and requirements for scale up of pharmaceutical products from R and D to plant.
2. What do you mean by the term Technology Transfer? Discuss in detail about WHO guidelines for Technology transfer.
3. Discuss the concept of quality, TQM, And Quality by design(QbD).
4. Define the term Regulatory Affairs. Discuss about the role of regulatory affairs department and responsibility of regulatory affairs professionals.
5. Give a detailed account on regulatory requirements and approval procedures for new drug.
6. Discuss general considerations of Investigational New Drug (IND) Application. Explain the role of biostatics in pharmaceutical product development.
7. Discuss in detail about ISO 9000 and ISO 14000 series of quality system standards.
8. Write short notes on:
A. TT agencies in india
B. SUPAC guidelines
C. Six sigma concept
D. Management of clinical studies.
9. Give a detailed account on regulatory requirements for drug approval.
10. What do you mean by quality risk management QRM? Write an exhaustive note on technology transfer agencies in India.
11. Discuss pilot plant scale up considerations for solids and semisolid.
12. Write an exhaustive note on Quality management system.
13. What are the different regulatory authorities? Discuss the role of regulatory affairs department and responsibility of regulatory affairs departments and responsibilities of regulatory affairs professionals.
14. Write short note on GLP.