Write about the uses of Platform Technology.
[6 marks]Write on Quality Risk Management.
[5 marks]Discuss responsibilities of regulatory affairs professionals.
[5 marks]Discuss historical overview of regulatory affairs.
[6 marks]Write a note on TIFAC.
[5 marks]Write in brief about APCTD and NRDC.
[5 marks]Write a note on SUPAC guidelines.
[6 marks]Write the protocol to conduct non clinical testing.
[5 marks]Discuss Investigational New Drug (IND) Application
[5 marks]Describe pilot plant scale up considerations for semi-solid dosage forms.
[6 marks]What are the objectives and significance of pilot plants?
[5 marks]Write a note on Total Quality Management.
[5 marks]Write in brief about qualification and validation in technology transfer.
[6 marks]Discuss about technology transfer protocol.
[5 marks]Write a note on Certificate of Pharmaceutical Product (COPP). Q. 6 (a) Write about significance of documentation in technology development and transfer.
[6 marks]Write a note on Six sigma as a tool for quality management.
[5 marks]How Bioequivalence are documented?
[5 marks]Describe Pilot plant scale up considerations for solid dosage forms.
[6 marks]Write about the role of regulatory affairs department in industry.
[5 marks]Discuss selection of pharmaceutical packaging materials.
[5 marks]