Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharma 2019 June (Master of Pharmacy) 1st Year (First Year) 2nd Year 5163 Audits And Regulatory Compliance Previous Question Paper

Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Degree Examination - JUNE 2019
[Time: 3 Hours]
[Max. Marks: 75]
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.
What are the roles of organizational and personnel as per Schedule M of the Drug and Cosmetic
Act, how are they audited?
2.
Explain in detail on how you audit the supplier of a critical excipient.
3.
Give a comprehensive audit checklist of pharmaceutical production systems and their rationale.
4.
Give the comprehensive objectives of pharmaceutical audits and their necessity in ensuring the
quality.
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Write a note of auditing of building and facilities of a pharmaceutical production unit.
6.
Briefly explain the responsibilities of auditors of auditees during a regulatory audit.
7.
Explain the auditing procedure of auditing water systems in a pharmaceutical production
facility.
8.
Explain how tableting procedures of a solid oral pharmaceutical product are audited against the
BMR.
9.
Explain the auditing of a blister packing line.
10.
How are Good Warehousing practices audited?
11.
Give a brief overview of auditing roles of the QAU.
12.
Explain the audits of pharmaceutical water systems.
13.
How are audit checklists prepared?
14.
Give a brief overview of auditing pharmaceutical manufacturing operations.
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