LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
1. List and explain the objectives of auditing pharmaceutical facilities.
2. Give a brief overview of auditing pharmaceutical production and process controls in a cGMP environment.
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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.
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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.
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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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