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1. How are ICH guidelines organized? Explain the milestones of ICH.
2. With a floor plan, illustrate the layout of a production facility for solid oral dosage forms as mandated by Schedule M.
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3. What is a Drug Master File? List its contents.
4. Explain the process of IPQC. Why is it essential? Illustrate the IPQC process for the manufacturing process of a capsule formulation.
SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
5. What details should the protocol for a GLP study encompass?
6. Compare the scope of QA and QC.
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7. Explain the environmental control requirements for various production areas.
8. Give the IPQC requirements for topical dosage forms as per IP.
9. Explain the QC tests prescribed for ophthalmic products.
10. How do you audit your vendor for ensuring your purchase specifications?
11. Explain the weight variation test for solid oral dosage forms as per IP.
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12. Explain the Common Technical Documentation triangle and its modules.
13. Explain how you will compute the expiry date of a drug product as per ICH requirements.
14. How will you handle the disposal of waste products incurred during a pharmaceutical production process?
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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