Write a detailed note on various level of changes in SUPAC guidelines.
[6 marks]Discuss pilot plant scale up consideration for oral liquids.
[5 marks]Discuss general consideration for space requirement for scale up techniques.
[5 marks]Discuss various documentation required for changes is batch size as per SUPAC guidelines.
[6 marks]Introduce platform technology with respect to pilot plant scale up technique.
[5 marks]What is Certificate of Pharmaceutical Product?
[5 marks]Discuss the scope of WHO guidelines on transfer of technology in pharmaceutical manufacturing.
[6 marks]Briefly describe technology transfer protocol.
[5 marks]Write a note on various technology transfer agencies in India.
[5 marks]Discuss confidentiality agreement in Technology Transfer.
[6 marks]Write in brief about Quality Risk Management with respect to Technology Transfer.
[5 marks]Describe in brief responsibilities of CDSCO.
[5 marks]What is IND Application. Discuss Emergency use IND Application.
[6 marks]Convey historical overview of Regulatory Affairs.
[5 marks]Briefly describe Management of Clinical trials. Q. 6 (a) Describe the responsibility of regulatory affairs professionals.
[6 marks]Describe the importance of Investigator’s Brochure.
[5 marks]Briefly discuss approval procedures for new drugs.
[5 marks]What is Six Sigma? Discuss the importance of Six Sigma concept.
[6 marks]Write a brief note on ISO 9000 series of quality standards
[5 marks]Write a note on procedure for change control.
[5 marks]