Describe the procedure for new drug approval from CDSCO in India.
[6 marks]Describe the investigator’s brochure for IND.
[5 marks]Write short note on Six sigma as a tool for quality management.
[5 marks]Write the benefits of ISO to an organization. Write a note on ISO 9001:2008.
[6 marks]Describe the basic concepts of TQM.
[5 marks]Discuss change control in quality management system.
[5 marks]Explain in brief SUPAC guidelines for immediate release solid oral dosage forms.
[6 marks]Write a note on platform technology citing appropriate example.
[5 marks]Write briefly on NABL certification.
[5 marks]Write a detail note on pilot plant scale up of tablets.
[6 marks]Discuss selection of pharmaceutical packaging materials.
[5 marks]Explain the documentation in technology transfer.
[5 marks]Write a note on “Approved regulatory bodies and agencies of India for TT”.
[6 marks]Write about role of regulatory affairs department.
[5 marks]Write a note on COPP. Q. 6 (a) What is Technology transfer? Write importance of Technology transfer in pharmaceutical industry.
[6 marks]Discuss in detail various factors affecting design of a pharmaceutical pilot plant facility.
[5 marks]Write a note on clinical research protocol.
[5 marks]Write a brief note on qualification and validation in technology transfer.
[6 marks]Write a note on state licensing authority under Indian regulatory requirements.
[6 marks]Write the protocol to conduct non clinical testing.
[6 marks]