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Rajiv Gandhi University of Health Sciences
First Year M. Pharm Degree Examination - Nov 2011
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[Time: 3 Hours]
[Max. Marks: 100]
GOOD MANUFACTURING AND LABORATORY PRACTICE
(RS 2 & RS 3)
Q.P. CODE: 9204
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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
- Explain the implementation of Good Manufacturing Practices in bulk manufacturing unit as per schedule M.
- Explain air - handling unit of a sterile manufacturing area
- Explain the Types, design and elements of good warehousing practices
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SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Classify ICH guidelines. Name at least four guidelines under each category
- Write a note on personnel training
- Explain the process of distribution and distribution control
- Define and classify validation. Explain the validation of equipments
- Explain the contents of a batch manufacturing record
- Write a note on label control
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SHORT NOTES 2 X 5 = 10 Marks
- Differentiate Quality Assurance and Quality Control
- Explain the importance of preventive maintenance
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