Define Pilot plant and scale up. Discuss importance of pilot plant study.
[6 marks]Explain in brief SUPAC guidelines for immediate release solid oral dosage forms.
[5 marks]Write a detail note on pilot plant scale up of tablets.
[5 marks]Write a note on scope and organization management as per WHO guideline.
[6 marks]Describe documentation requirement for transfer the technology from R & Dto manufacture level.
[5 marks]Briefly describe technology transfer protocol.
[5 marks]What is Investigational New Drug (IND) Application? Explain Requirement and types of an IND.
[6 marks]Explain Clinical trial Management Studies in details.
[5 marks]Describe the role and responsibility of regulatory affairs professionals.
[5 marks]Write a brief note on ISO 9000 series of quality standards
[6 marks]Explain purpose, benefits and elements Total Quality Management.
[5 marks]Discuss on NABL certification in detail.
[5 marks]Write a note on Certificate of Pharmaceutical Product (COPP).
[6 marks]What is CDSCO? Explain function of CDSCO in details.
[5 marks]Explain Organization and Responsibilities of State Licensing Authority in India. Q. 6 (a) Explain platform technology with respect to pilot plant scale up technique.
[6 marks]Describe the importance of Investigator’s Brochure.
[5 marks]Explain review process for New Drug Application (NDA).
[5 marks]Write a note on “Approved regulatory bodies and agencies of India for TT”.
[6 marks]Write a note on Out of Specifications (OOS).
[5 marks]Briefly discuss approval procedures for new drugs.
[5 marks]