What is Six Sigma. Describe the importance of six sigma in achieving “zero defect”?
[6 marks]Describe in general out of specifications with respect to quality management?
[5 marks]Introduce ISO 9000 as a series of quality system standards.
[5 marks]Describe documentation required for changes is batch size as per SUPAC guidelines.
[6 marks]Discuss pilot plant scale up consideration for semi-solids.
[5 marks]Write a note on significance of space requirement for scale up techniques.
[5 marks]Discuss platform technology for scale up techniques with appropriate examples.
[6 marks]Describe importance of raw materials with respect to pilot plant scale up.
[5 marks]Write a note on certificate of pharmaceutical product (COPP).
[5 marks]Discuss the scope of WHO guidelines on transfer of technology in pharmaceutical manufacturing.
[6 marks]Write a detailed note on various level of changes in SUPAC guidelines.
[5 marks]Describe the organization and responsibilities of CDSCO.
[5 marks]Write a note on various agencies involved in technology transfer in India.
[6 marks]Discuss technology transfer related documentation for confidentiality agreement.
[5 marks]Briefly discuss approval procedures for new drugs in CDSCO. Q. 6 (a) Introduce quality risk management with respect to technology transfer.
[6 marks]Explain the importance of Investigator’s Brochure.
[5 marks]Convey historical overview of Regulatory Affairs.
[5 marks]What is IND Application. Discuss Emergency use IND Application.
[6 marks]Briefly describe Management of Clinical trials.
[5 marks]Describe the responsibility of regulatory affairs professionals.
[5 marks]