M Pharm Il Semester Regular & Supplementary Examinations, August 2014
CURRENT PHARMACEUTICAL ASPECTS OF INDUSTRY
(Pharmaceutics)
Time: 3 hours Max Marks: 60
Answer any FIVE questions
All questions carry equal marks
All questions carry equal marks
1. (a) Write a note on construction and working of freeze dryer
(b) Describe the design, specifications and applications of air filtration systems
2. (a) compare the regulatory affair aspects in the context of india European and United States norms.
(b) Describe the processes for equipment validation,
3. (a) Write a note on ideal characteristics of packaging materials. How is the interaction between dosage forms and packaging materials studied
(b) Compaire the advanced packaging materials with the conventional packaging materials with suitable examples.
4. (a) Write a note on method of least square and its applications,
(b) Describe methods of collection and classification of data and importance of statistical treatment.
5. Write a detailed note on ICH guidelines for stability testing of dosage forms.
6. (a) write a note on causes of industrial hazards. Describe the monitoring and prevention of hazards due to mechanical and electrical equipments
(b) What are the measures to prevent accidents due to chemical exposure.
7. (a) write a note on regulatory requirements for use of animals in laboratory for new drug development
(b) write a note on ethical consideration in the studies on human volunteers what type of documentation is necessary in the human studies?
8 (a) Give a detailed note on applications of radiopharmaceuticals
(b) Describe the safety precautions for radiopharmaceuticals
