Questions on Technology development and Transfer

 

10 Marks Questions:

1. Explain the key components of the WHO guidelines for Technology Transfer (TT) and how they contribute to ensuring the quality and safety of pharmaceutical products. Provide examples where relevant.
2. Discuss the process of transferring technology from Research and Development (R&D) to production, particularly focusing on the challenges and risk management strategies involved. Use specific examples from the pharmaceutical industry.

5 Marks Questions:

1. Define and elaborate on the concept of "Granularity of TT Process" as it relates to pharmaceuticals. How does it impact the technology transfer of finished products?
2. What role do premises and equipment play in ensuring successful technology transfer in the pharmaceutical industry? What is importance of qualification and validation in this context?
3. Describe the quality control measures that need to be in place during the technology transfer process. How does analytical method transfer contribute to quality assurance?
4. Explain the significance of approved regulatory bodies and agencies in the context of technology transfer for pharmaceutical products. Provide examples of such regulatory bodies and their roles.
5. Using case studies or real-world examples, discuss the practical aspects and common problems associated with the commercialization of pharmaceutical technologies. Highlight the role of technology transfer in this process.
6. Briefly introduce the technology transfer agencies in India, including APCTD, NRDC, TIFAC, BCIL, and TBSE/SIDBI. Describe their primary functions and contributions to technology transfer in the country.

2 Marks Questions:

1. What is the purpose of a confidentiality agreement in technology transfer, and why is it important in the pharmaceutical industry?
2. Differentiate between licensing and Memorandums of Understanding (MoUs) in the context of technology transfer. When might each be more appropriate?
3. What is the significance of quality risk management in technology transfer within the pharmaceutical industry?
4. How does documentation play a crucial role in ensuring the success of technology transfer processes in pharmaceutical manufacturing?
5. Explain the importance of legal issues in technology transfer, particularly in the context of pharmaceutical products.
6. What is the role of packaging materials in technology transfer, and why is it essential to consider them in the process?
7. Describe the primary objectives of technology transfer protocols and their role in ensuring consistency in pharmaceutical manufacturing.