RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Second Semester Examination
Audits and Regulatory Compliance
Q.P. CODE: 5163
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[Time: 3 Hours] [Max. Marks: 75]
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
- What are the roles of organizational and personnel as per Schedule M of the Drug and Cosmetic Act, how are they audited?
- Explain in detail on how you audit the supplier of a critical excipient.
- Give a comprehensive audit checklist of pharmaceutical production systems and their rationale.
- Give the comprehensive objectives of pharmaceutical audits and their necessity in ensuring the quality.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write a note of auditing of building and facilities of a pharmaceutical production unit.
- Briefly explain the responsibilities of auditors of auditees during a regulatory audit.
- Explain the auditing procedure of auditing water systems in a pharmaceutical production facility.
- Explain how tableting procedures of a solid oral pharmaceutical product are audited against the BMR.
- Explain the auditing of a blister packing line.
- How are Good Warehousing practices audited?
- Give a brief overview of auditing roles of the QAU.
- Explain the audits of pharmaceutical water systems.
- How are audit checklists prepared?
- Give a brief overview of auditing pharmaceutical manufacturing operations.
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