Define Pilot plant and scale up. Discuss importance of pilot plant study.
[6 marks]Discuss various levels of changes under distinct headings of any two changes in context to SUPAC - Immediate Release Solid Oral Dosage Form.
[5 marks]What is pilot plan study? Discuss objective and steps for pilot plan scale up study.
[5 marks]Write a note on Certificate of Pharmaceutical Product (COPP).
[6 marks]Describe documentation requirement for transfer the technology from R & Dto manufacture level.
[5 marks]Discuss SUPAC guidelines for semisolid dosage forms with reference to the components and composition changes.
[5 marks]What is Investigational New Drug (IND) Application? Explain Requirement and types of an IND.
[6 marks]Write a note on ANDA.
[5 marks]Explain Clinical trial Management Studies in details.
[5 marks]Explain ISO 9000 series of quality systems standards for pharmaceutical product.
[6 marks]Write a note on Out of Specifications (OOS).
[5 marks]Explain purpose, benefits and elements Total Quality Management.
[5 marks]Explain review process for New Drug Application (NDA).
[6 marks]Write a note on scope and organization management as per WHO guideline.
[5 marks]Describe steps in technology transfer process for pharmaceutical industry. Q. 6 (a) What is CDSCO? Explain function of CDSCO in details.
[6 marks]Write a note on Certificate of Pharmaceutical Product (COPP).
[5 marks]Explain Regulatory requirements and approval procedures for New Drugs in India.
[5 marks]Write a note on Change control in pharmaceutical company with examples.
[6 marks]Explain Organization and Responsibilities of State Licensing Authority in India.
[5 marks]How to Data Presentation for FDA Submissions? Explain in details.
[5 marks]