RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Q.P. CODE : 9204
Your answers should be specific to the questions asked.
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Draw neat labeled diagrams wherever necessary. Answer all questions
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- Discuss the organizational set up of Quality Control unit, their responsibilities and various activities of the organization.
- a) What is the design of the air control system adopted in the manufacturing units of antibiotics?
b) Discuss the procedure to handle the complaints, its evaluation and rectification. - a) List out the ICH guidelines to qualify and quantify impurities in new drug substances.
b) What are precautions to be taken in handling the cytotoxic substances in the manufacturing unit?
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- What are the measures to be considered before constructing a manufacturing unit?
- List out the Good Laboratory Practice regulations to be followed in caring animals.
- What do you mean by compliance of policy guidelines?
- What is statutory certificate of suitability? Give its significance.
- Discuss the various warehousing procedure for drug products
- Write about validation equipments and documentation procedure to be followed in Industry.
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SHORT NOTES 2 X 5 = 10 Marks
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- What are the merits and short coming of using computer in maintaining Good Laboratory Practice and good Manufacturing practice?
- International Standards Organization standards 14642-14644
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