This download link is referred from the post: RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Examination - 2023
[Time: 3 Hours] [Max. Marks: 75]
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Audits and Regulatory Compliance -II
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
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- What is cGMP? Explain cGMP Regulations and management responsibilities during audit in pharmaceutical manufacturing environment.
- Give the questionnaire list in the auditing of warehouse and weighing department.
- Describe product and process information auditing in the microbiological laboratory.
- Explain the auditing of engineering department in the pharmaceutical industry.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- What are different types of auditing? Describe the planning process of the Auditing.
- What is the importance of the auditing and discuss on the auditing reports.
- Explain the auditing of the manufacturing operations in vendor production department.
- Write about the GMP evaluation activities for audit in manufacturing environment.
- Write a note on auditing check list for capsule manufacturing department.
- Give the audit check list for tablet coating in manufacturing department.
- What are different types of waters? Write a brief note on auditing of water in the microbiology laboratory.
- Write a note on auditing of ‘raw material’ control in the microbiology laboratory.
- Explain HVAC audit.
- Write a note on the audit check list of ‘environment treatment plant’?
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This download link is referred from the post: RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
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