Download RGUHS M.Pharm 2nd Year 2020 5163 Audits And Regulatory Compliance Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharm (Master of Pharmacy) 2nd Year (2nd Semester) 2020 5163 Audits And Regulatory Compliance Previous Question Paper

Rajiv Gandhi University of Health Sciences, Karnataka
Second Semester M. Pharm Degree Examination - 16-Jan-2020
Time: Three Hours
Max. Marks: 75 Marks
AUDITS AND REGULATORY COMPLIANCE
Q.P. CODE: 5163
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.
List and explain the objectives to be attained during compliance audits of pharmaceutical
facilities.
2.
Give a brief overview of auditing pharmaceutical production and process controls in a cGMP
environment.
3.
Give an overview of auditing procedure of a supplier of API.
4.
Explain the procedure of auditing water quality in a pharmaceutical production facility.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
With a flow chart explain the auditing procedure of control of drug product containers and
closures.
6.
Explain the auditing procedure of holding and release of finished products to the market.
7.
Explain how granulation procedures of a pharmaceutical product are audited against the BMR.
8.
Explain the auditing of a HCG capsule filling line.
9.
Write a short note on the audits of active and inactive raw material control.
10. How do you audit the efficacy of a pharmaceutical product by PET?
11. Write a note on auditing ETPs by pollution control authorities.
12. Give a brief overview of management responsibilities during a regulatory audit.
13. Explain the methodological perspective of a pharmaceutical audit.
14. Why are audits essential in assuring pharmaceutical quality?
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