Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2010 May (Master of Pharmacy) 1st Year 9204 Good Manufacturing And Laboratory Practice Revised Scheme 2 Previous Question Paper
Rajiv Gandhi University of Health Sciences
First Year M.Pharm Degree Examination ? May 2010
[Time: 3 Hours]
[Max. Marks: 100]
GOOD MANUFACTURING AND LABORATORY PRACTICE
(Revised Scheme 2)
Q.P. CODE : 9204
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
1.
a) Discuss the Environmental control in the factory
b) Give the qualification, experience, hygiene and training of recruit
2.
a) Elaborate the utilities and facilities required by bulk drug industry
b) Controls to be imposed for Drug substance
3.
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
SHORT ESSAY (Answer any FIVE)
5 X 10 = 50 Marks
4.
In a manufacturing unit they are supposed to receive chloroform, ether, pesticides and
MORTEIN RAT KILLER, how to handle it. Explain
5.
Explain the certificate for stability testing of pharmaceuticals
6.
Describe the requirements for animal testing facility
7.
What are the differences present between FDA guidelines and schedule M proposed by Govt. of
India?
8.
What is statutory certificate of suitability? Explain the trade mark act
9.
Describe in detail about the applications of modern equipments in practical GLP
SHORT NOTES
2 X 5 = 10 Marks
10. Discuss the ICH guidelines for efficacy
11. Write short notes on construction and maintenance of material store room
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This post was last modified on 11 June 2021