Download RGUHS (Rajiv Gandhi University of Health Sciences) M Pharma (Master of Pharmacy) First Year (1st Year) Nov 2011 9293 Quality Assurance Paper Iii Rs 2 And Rs 3 Question Paper.
Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination ? Nov 2011
[Time: 3 Hours] [Max. Marks: 100]
QUALITY ASSURANCE
PAPER III
(RS 2 & RS 3)
Q.P. CODE: 9293
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. Explain the location, plan and layout requirement for a sterile dosage form manufacturing unit
2. Write a note on planning, execution and closing of regulatory audit of a pharmaceutical
manufacturing unit
3. Differentiate loan license manufacturing and contract manufacturing. Explain the
implementation of GMP for these activities
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
4. Write a note on personnel hygiene
5. Explain the methods and precautions for control of contamination in non sterile dosage forms
6. Write a typical purchase specifications and maintenance SOP for HPLC with UV detector
7. Explain the salient features of factory Act
8. What are batch release documents? Explain each document in detail
9. Write a note on cleaning validation
SHORT NOTES 2 X 5 = 10 Marks
10. Explain reprocessing of non ? sterile dosage forms with special emphasis on stability
11. Write a note on retention sample
* * * * *
FirstRanker.com - FirstRanker's Choice
This post was last modified on 20 December 2019