Download RGUHS M.Pharm 1st Year 2020 5103 5103 Quality Control And Quality Assurance Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharm (Master of Pharmacy) 1st Year (First Semester) 2020 5103 5103 Quality Control And Quality Assurance Previous Question Paper

Rajiv Gandhi University of Health Sciences, Karnataka
First Semester M. Pharm Degree Examination - 14-Jan-2020
Time: Three Hours
Max. Marks: 75 Marks
QUALITY CONTROL AND QUALITY ASSURANCE
Q.P. CODE: 5103
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
How are ICH guidelines organized by scope? List and explain briefly the Q-series guidelines of
ICH.
2.
With a floor plan the layout of a production facility for solid oral dosage forms as mandated by
Schedule M.
3.
What is a Drug Master File? List its contents.
4.
Explain the process of IPQC. Why is it essential? Illustrate the IPQ process for manufacturing
process of a capsule formulation.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
What details should the protocol for a GLP study encompass?
6.
Compare the scope of QA and QC
7.
Explain the environmental control requirements for various production areas.
8.
Give the IPQC requirements for topical dosage forms as per IP.
9.
Explain the QC tests prescribed for ophthalmic products.
10. How do you audit your vendor for ensuring your purchase specifications?
11. Explain the weight variation test for solid oral dosage forms as per IP.
12. Explain the Common Technical Documentation triangle and it's modules.
13. Explain how you will compute expiry date of a drug product as per ICH requirements.
14. How will you handle disposal of waste products incurred during a pharmaceutical production
process?
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