Download RGUHS M.Pharmacy First Year May 2016 9360 Chemical And Biological Evaluation Revised Scheme 4 Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M Pharma (Master of Pharmacy) First Year (1st Year) May 2016 9360 Chemical And Biological Evaluation Revised Scheme 4 Question Paper.

Rajiv Gandhi University of Health Sciences, Karnataka
First Year M. Pharm Degree Examination ? MAY 2016

Time: Three Hours Max. Marks: 100 Marks

CHEMICAL & BIOLOGICAL EVALUATION
(Revised Scheme 4)
Q.P. CODE: 9360

Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary

LONG ESSAYS (Answer any Two) 2 x 20 = 40 Marks
1.
Explain in detail about GLP and WHO certification for export of pharmaceuticals.
2.
a) Explain calibration of UV-Visible Spectrophotometer and HPLC.
b) Discuss Solid phase micro extraction and biological method validation as per ICH
guidelines. (10+10)
3
Explain microbiological validation with examples and sterility testing methods.
b) Discuss the concept of enzyme immuno assays with example. (10+10)

SHORT ESSAYS (Answer any FIVE) 5 x 10 = 50 Marks
4.
Discuss drug rules of Schedule M and reprocessing and salvaging of returned goods.
5.
Write in detail principle and procedure involved in the biological assay of streptokinase and
tuberculin purified protein derivative.
6.
Discuss Q
3
B and Q
3
C ICH guideline.
7.
Give source, chemistry and properties of endotoxins and explain official pyrogen testing
methods.
8.
Explain cleaning and personnel validation.
9.
Write on development of drug information profile and microbial assays of antibiotics.

SHORT NOTES 2 x 5 = 10 Marks
10.
Write a note on concepts of Laboratory Information Management System (LIMS).
11.
Write a note on test of antimicrobial preservatives.

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