Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - May 2016
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[Time: 3 Hours] [Max. Marks: 100]
Pharmaceutical Technology and Validation
(Revised Scheme 4)
Q.P. CODE: 9362
Your answers should be specific to the questions asked.
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Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any TWO) 2 X 20 = 40 Marks
- What are the types of Compatibility Studies to be carried out during Preformulation and how is the Compatibility assessed? Explain in detail.
- Classify Drug Substances as per BCS. Explain the approaches adopted to increase the Dissolution of Class III and Class IV drugs.
- What are the types of Qualifications? Explain the types of Qualifications and Records there of for a Capsule Filling Machine.
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Differentiate Stability Testing of a Drug Product and Drug Substance as per ICH Q2A (R1).
- Write a note on SUPAC.
- Explain the Quality Control Testing of Type II Glass Containers along with Acceptance criteria.
- Write a Representative MVP (Master Validation Plan) for a Tunnel Sterilizer.
- What are the Innovative Packaging Technologies available for Oral Dosage Forms? Explain.
- Write a Typical Process Validation Protocol for "Diclofenac Sodium Gel".
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SHORT NOTES 2 X 5 = 10 Marks
- Explain the terms "Clean in Place” and “Sterile in Place".
- Write a note on GAMP Good Practice guidelines?
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