Rajiv Gandhi University of Health Sciences
First Year M Pharm Degree Examination
Preformulation and Production Management
(Revised Scheme 4)
Q.P. CODE: 9337
[Time: 3 Hours] [Max. Marks: 100]
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Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary. Answer any ten questions.
LONG ESSAY (Answer any TEN) 10 X 10 = 100 Marks
- Explain different methods to enhance the solubility of a poorly soluble drug.
- a) Write short note on parameters for physical stability testing.
b) Explain the different tools used in quality by design. - Compare and contrast the formulation variables between sublingual and buccal tablets.
- Explain photostability and oxidative stability studies.
- Explain safety stock, stock out, lead time and modern inventory management system.
- Explain (a) Validation of HVAC system (b) Validation protocol for water system.
- Explain (a) Centralized and decentralized purchasing (b) Different methods of buying techniques.
- a) Define and explain trademark protection law.
b) Explain non-obviousness in patent law. - Explain in detail about mechanical hazards and its control and preventive measures.
- Explain the general procedure for pilot plant scale up technique in pharmaceutical industries.
- Discuss the role of (a) WIPO (b) TRIPS.
- Define optimization. Explain about statistical design of experiment by simplex and factorial design.
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