RGUHS M.Pharm 1st Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - Nov 2023
[Time: 3 Hours] [Max. Marks: 100]
Quality Assurance
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(Revised Scheme 4)
Q.P. CODE: 9361
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
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- Explain in detail quality audits of manufacturing processes and facilities. Write a note on audits of quality control.
- Write a typical standard operating procedure for a 16-station rotary tablet compression machine.
- Write a note on “Investigator Brochure” as per ICH E6 guidelines.
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Write a note on qualification and training of a new quality control chemist and new production chemist as per schedule M.
- A batch of enteric-coated tablets failed to meet disintegration specifications. Explain the investigation process and CAPA (Corrective and Preventive Actions) for the same.
- Name and explain the significance of any three “In Process Quality Control Tests” for injections and capsules.
- Write a standard testing protocol for the assay of Paracetamol tablets IP.
- Write a note on “Good Warehousing Practices”.
- Write a note on new drug product registration in United States of America.
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SHORT NOTES 2 X 5 = 10 Marks
- What are Trademarks and Copyrights?
- What are online, inline and atline testing as per PAT guidelines of USFDA?
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