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Current Pharmaceutical Aspects of Industry M.Pharm Previous Question Paper , Feb 2016

M. Pharm Il semester supplementary Examinations, February 2016

Max Marks: 60                                                                                       Time: 3 hours
Answer any FIVE questions
All questions carry equal marks
1. Write in detail about advances and various techniques used in pharmaceutical packaging and its lmportance.
2. Explain about the validation of equipment process regulatory requirements as per GMP, GLP and CGMP specifications,
3. Discuss about
(a) Quality control charts and its application in process control.
(b) Test of significance and statistical quality control.
4. Write importance of the following equipment in manufacturing of formulations and its description.
(a) High pressure homogenizer.
(b) Tray dryer.
(c) Rapid mixers in granulation process.
5. Explain about
(a) Protocols and requirements for new drug approval.
(b) Production storage and applications of radio pharmaceuticals
6. Give an account on.
(a) correlation coefficient and multiple regressions.
(b) Laws of probability and method of teast squares and its uses.
7. Write short note on.
(a) Regulatory affair procedures in Europen and united States context,
(b) Monitoring and prevention methods due to fire accidents in pharmaceutical industries
8. Write detailed note on
(a) Collection of experimental data and its statistical treatment.
(b) Pan coating equipment description.
(c) Significance of t- test.

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