First Year M. Pharm Degree Examination - Oct/Nov 2014
[Time: 3 Hours] [Max. Marks: 100]
GOOD MANUFACTURING AND LABORATORY PRACTICE
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(RS 2 & RS 3)
Q.P. CODE: 9204
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
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- Explain the process of recovered goods, remarking and reprocessing
- Write a note on good warehousing practices
- Explain the elements of ISO 9000 : 2000 in detail
SHORT ESSAY (Answer any FIVE) 5 X 10 = 50 Marks
- Explain the stability testing of drug product as per ICH guidelines
- Explain the premises requirement for a non-sterile dosage from manufacturing unit as per schedule M
- Write a note on inventory control
- Explain the process of handling returned goods
- Explain the analytical method validation as per ICH guidelines
- Explain clean in place and sterile in place
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SHORT NOTES 2 X 5 = 10 Marks
- Differentiate the GLP requirements of formulation plant and bulk drug plant
- What is quarantine? Explain its significance
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