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M Pharm 2nd Semester Supplementary Examinations, April 2013

Time: 3 hours                                                                                               Max Marks: 60
Answer any FIVE questions
All questions carry equal marks
1 (a) Define the following
(i) Sterilization.
(ii) HEPA filters,
(iii) Homogenizer.
(iv) Granulators.
(v) Dryers.
(b) Write in detail about rotary tablet punching machines with neat labeled diagram and applications
2. Write in detail about validation of equipment and its regulatory requirements with reference to good manufacturing practices
3. Write in detail about advances in pharmaceutical packing and compare with the existing packing systems.
4. Explain stability protocols of pharmaceutical dosage forms as per ICTI guidelines.
5.  Classify different types of industrial hazards and write briefly about monitoring and prevention of various types of hazards.
6.  Explain in detail about process controls involved in manufacturing process of pharmaceutical dosage forms.
7. What are the regulatory requirements on animal and human studies for drug development requirements for new drug approval?
8. (a) write briefly about radio pharmaceuticals production control and safety precautions
(b) Applications of radio pharmaceutical,

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