Discuss platform technology for scale-up techniques with appropriate examples.
[6 marks]Write a note on various technology transfer agencies in India.
[5 marks]Write a detailed note on various levels of changes in SUPAC guidelines.
[5 marks]Write in brief about qualification and validation in technology transfer.
[6 marks]Describe the documentation requirement for transferring the technology from R & Dto the manufacturing level.
[5 marks]Write a note on COPP.
[5 marks]Write on Quality Risk Management.
[6 marks]Explain the importance of the Investigator’s Brochure.
[5 marks]Write a note on Out of Specifications (OOS).
[5 marks]What is Six Sigma? Discuss the importance of the Six Sigma concept
[6 marks]Introduce ISO 9000 as a series of quality system standards.
[5 marks]Describe the basic concepts of TQM.
[5 marks]Describe the procedure for new drug approval from CDSCO in India.
[6 marks]Explain the purpose, benefits, and elements of Total Quality Management
[5 marks]Explain the Organization and Responsibilities of the State Licensing Authority in India. Q. 6 (a) Describe pilot plant scale-up considerations for semi-solid dosage forms.
[6 marks]How Bioequivalence is documented?
[5 marks]Write in brief about APCTD and NRDC.
[5 marks]Describe Pilot plant scale-up considerations for solid dosage forms.
[6 marks]Write a note on TIFAC
[5 marks]Discuss the responsibilities of regulatory affairs professionals.
[5 marks]