Biosafety Class S.Y.B.T. Past Paper PDF

# QUESTION BANK ## Class: S.Y.B.T. ## SEMESTER III ## SUBJECT PAPER: BIOSAFETY ### Descriptive Questions (8 Marks/7 Marks) / Short Notes (5 Marks) **UNIT I** 1. Give an account on laboratory associated Infections (LAIs). 2. Comment on Agent Summary Statements. 3. Give classification of infectious...

# QUESTION BANK ## Class: S.Y.B.T. ## SEMESTER III ## SUBJECT PAPER: BIOSAFETY ### Descriptive Questions (8 Marks/7 Marks) / Short Notes (5 Marks) **UNIT I** 1. Give an account on laboratory associated Infections (LAIs). 2. Comment on Agent Summary Statements. 3. Give classification of infectious microorganisms as per the risk groups according to hazardous characteristics. 4. Discuss - Genetically Modified Agent Hazards. 5. Discuss the risk of hazardous agents from cell cultures. 6. Discuss the risk of hazardous agents from laboratory procedures. 7. Explain the potential risk hazards associated with work practices. 8. Explain the potential risk hazards associated with facility safeguards. 9. Discuss - Approach of assessment of risk and selection of appropriate safeguards. 10. What is GLP? Explain the risk of resources like organization, facilities and equipment in GLP. 11. What is GLP? Explain the risk of resources like animal facilities in GLP. 12. What is GLP? Explain the risk of personnel management for the effective implementation of 13. Explain the twelve quality system essentials of laboratory quality management system. 14. What is Laboratory Audit? Explain External Audit of Laboratory. 15. What is Laboratory Audit? Explain Internal Audit of Laboratory. E plain continuous quality management process as a part of action taken after audit results. **UNIT III** 1. What is microbial contamination? Explain manifestation of microbial contaminants with respect to toxic effects and metabolic products. 2. What is microbial contamination? Explain manifestation of microbial contaminants with respect to change of activity and visible effects. 3. What is microbial contamination? Explain manifestation of microbial contaminants with respect to colour change and gas production. 4. What is microbial contamination? Explain manifestation of microbial contaminants with respect to irritancy, olfactory effects and texture. 5. What is microbial contamination? Explain manifestation of microbial contaminants with bioburden test. 6. What is microbial contamination? Explain manifestation of microbial contaminants with sterility testing. 7. What is microbial contamination? Explain manifestation of microbial contaminants with LAL test for bacterial endotoxins. 8. What is microbial contamination? Explain manifestation of microbial contaminants with water testing for pharmaceutical products. 9. Explain water, simple aqueous solutions, emulsions and suspensions as the sources of contamination. 10. Explain creams and syrups as the sources of contamination. 11. Explain raw materials and packaging materials as the sources of contamination. 12. What is pharmaceutical regulation? Explain in brief following pharmaceutical testings: stability testing for preservatives and total bacterial count. 13. What is pharmaceutical regulation? Explain in brief following pharmaceutical testings: sterility testing, bacterial endotoxin testing and microbiological water testing. 14. What is pharmaceutical regulation? Explain in brief following pharmaceutical testings : microbial limit test and total fungal counts. 15. Explain the disc diffusion and turbidimetric microbial assay methods. 16. Explain urease assay and luciferase microbial assay methods. 17. Discuss water, air and raw material as the sources of microbial contamination. 18. Discuss human resource and personnel as the sources of microbial contamination. **(Yogesh Salvi)** **(Subject Teacher)**