FirstRanker Logo

FirstRanker.com - FirstRanker's Choice is a hub of Question Papers & Study Materials for B-Tech, B.E, M-Tech, MCA, M.Sc, MBBS, BDS, MBA, B.Sc, Degree, B.Sc Nursing, B-Pharmacy, D-Pharmacy, MD, Medical, Dental, Engineering students. All services of FirstRanker.com are FREE

📱

Get the MBBS Question Bank Android App

Access previous years' papers, solved question papers, notes, and more on the go!

Install From Play Store

Download RGUHS M.Pharm 2019 Jan 2nd Year 5163 Audits And Regulatory Compliance II Question Paper

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

This post was last modified on 11 June 2021

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]

--- Content provided by FirstRanker.com ---

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

--- Content provided by FirstRanker.com ---

  1. What is cGMP? Explain cGMP Regulations and management responsibilities during audit in pharmaceutical manufacturing environment.
  2. Give the questionnaire list in the auditing of warehouse and weighing department.
  3. Describe product and process information auditing in the microbiological laboratory.
  4. Explain the auditing of engineering department in the pharmaceutical industry.

SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks

--- Content provided by FirstRanker.com ---

  1. What are different types of auditing? Describe the planning process of the Auditing.
  2. What is the importance of the auditing and discuss on the auditing reports.
  3. Explain the auditing of the manufacturing operations in vendor production department.
  4. Write about the GMP evaluation activities for audit in manufacturing environment.
  5. Write a note on auditing check list for capsule manufacturing department.
  6. --- Content provided by FirstRanker.com ---

  7. Give the audit check list for tablet coating in manufacturing department.
  8. What are different types of waters? Write a brief note on auditing of water in the microbiology laboratory.
  9. Write a note on auditing of ‘raw material’ control in the microbiology laboratory.
  10. Explain HVAC audit.
  11. Write a note on the audit check list of ‘environment treatment plant’?
  12. --- Content provided by FirstRanker.com ---

FirstRanker.com



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

--- Content provided by FirstRanker.com ---