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Second Semester Degree Examination
[Time: 3 Hours] [Max. Marks: 75]
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Documentation and Regulatory Writing
Q.P. CODE: 5145
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 product development report (PDR)? Discuss the significance of PDR. (6+4)
- Define CTD and eCTD. Describe the modules of ICH-CTD format with granularity. (2+8)
- What are audits? Explain the process of preparation and conduct of Audits. (2+4+4)
- Discuss the Root cause analysis of a deviation. Describe corrective and preventive action (CAPA) process. (4+6)
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
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- Describe about Batch Manufacturing Record (BMR) and its calculations.
- What is Drug Master File (DMF)? Discuss the types of DMFs.
- Outline the contents and organization of dossiers.
- Discuss the Non eCTD electronic submission (NeeS) format and its difference with CTD.
- Differentiate internal, external, second party and external third party audits.
- Describe the quality systems requirements of national good distribution practices.
- Summarize the process and need in inspection of drug distribution channels.
- Discuss the Post Approval Changes (SUPAC) process for an approved drug product.
- Describe the process of post approval labeling changes.
- Discuss the electronic submission process and validating the submission.
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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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