FirstRanker's AP
Rajiv Gandhi University of Health Sciences, Karnataka
First Year M. Pharm Degree Examination – May 2012
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[Time: 3 Hours]
[Max. Marks: 100]
QUALITY ASSURANCE
PAPER III
(RS 2 & RS 3)
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Q.P. CODE: 9293
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 content, format and control of master formula record, batch manufacturing record and batch packing record
- Name and explain different types of sterilization along with their merits and demerits
- Explain GLP in detail
SHORT ESSAY (Answer any FIVE)
5 X 10 = 50 Marks
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- What is total quality management? Explain
- What is clean in place? Explain the methods of attaining and ensuring the same
- Write a note on vendor validation
- Name different types of primary packing materials used for pharmaceuticals. Explain the sampling and quality control of labels
- Write a note on good warehousing practices
- What is a recall? What are the types of all and how are they handled
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SHORT NOTES
2 X 5 = 10 Marks
- What is the importance of personnel training in implementing GMP
- Write objectives and benefits of ISO 9000:2000
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