Write a note on personnel requirement, space requirement and responsibility in terms of pilot plant studies.
[6 marks]Write a note on SUPAC for IR dosage form.
[5 marks]Write a note on pilot plant scale up studies for liquid dosage form.
[5 marks]Differentiate IND and NDA. Brief considerations of IND.
[6 marks]Explain roles and responsibilities of regulatory affairs.
[5 marks]Write a note on clinical research protocol submission.
[5 marks]Briefly explain the brief Overview of Quality by Design Process.
[6 marks]Enumerate and briefly explain the various tools used in Total quality management.
[5 marks]Explain the six sigma methodology implementation.
[5 marks]What is CDSCO? Explain its role in regulatory requirement.
[6 marks]Brief about organization and responsibilities of COPP.
[5 marks]Explain Regulatory requirements and approval procedures for New Drugs.
[5 marks]Explain quality risk management in technology transfer.
[6 marks]Describe steps in technology transfer process for pharmaceutical industry
[5 marks]Brief various practical aspects and problems involved in commercialization process. Q. 6 (a) Explain importance of biostatistics in pharmaceutical product development.
[6 marks]Describe in detail elements of ISO 9000.
[5 marks]Write a note on platform technology.
[5 marks]Write a note on data presentation for submission to FDA.
[6 marks]Mention approved agencies for TT and explain them.
[5 marks]Describe the investigator’s brochure for IND.
[5 marks]