RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- a) Discuss the Environmental control in the factory
b) Give the qualification, experience, hygiene and training of recruit - a) Elaborate the utilities and facilities required by bulk drug industry
b) Controls to be imposed for Drug substance - a) How to handle the complaints received. Detail its evolution and discuss the rectification
b) Quality audit of manufacturing plant
c) Discuss the phases of certification of ISO 9000 series
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- In a manufacturing unit they are supposed to receive chloroform, ether, pesticides and MORTEIN RAT KILLER, how to handle it. Explain
- Explain the certificate for stability testing of pharmaceuticals
- Describe the requirements for animal testing facility
- What are the differences present between FDA guidelines and schedule M proposed by Govt. of India?
- What is statutory certificate of suitability? Explain the trade mark act
- Describe in detail about the applications of modern equipments in practical GLP
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SHORT NOTES 2 X5 = 10 Marks
- Discuss the ICH guidelines for efficacy
- Write short notes on construction and maintenance of material store room
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