RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - May 2013
[Time: 3 Hours] [Max. Marks: 100]
GOOD MANUFACTURING AND LABORATORY PRACTICE
(RS 2 & RS 3)
Q.P. CODE: 9204
--- Content provided by FirstRanker.com ---
Your answers should be specific to the questions asked.
Draw neat labeled diagrams wherever necessary. Answer all questions
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- a) Describe in detail about the applications of Modern equipments in practical GLP
b) What are the differences between FDA guidelines and schedule ‘M’ proposed by govt. of India. - a) Write the specific requirements for the manufacturing area of sterile products
--- Content provided by FirstRanker.com ---
b) Discuss the concepts of production planning and control - a) Distinguish between quality control and quality assurance
b) Give a note on ISO 9000.
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Discuss the product recall with reference to recall procedures
- List out the various responsibilities of a qualified personnel in a manufacturing unit.
- Explain briefly about utilities and facilities of organization
- What are the precautions to taken to maintain sanitation?
- Define the term process validation and explain the terms prospective and retrospective validation
- Give a note on ICH guidelines followed by industries while the preparation of sterile products
--- Content provided by FirstRanker.com ---
SHORT NOTES 2 X5 = 10 Marks
- Give an account of evaluation of complaints
- Write a note on master formula records
--- Content provided by FirstRanker.com ---
For more resources, visit: FirstRanker.com
--- Content provided by FirstRanker.com ---
This download link is referred from the post: RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences