Important Questions for IP 2
I) Write a note on pilot plant scale up for semi-solid dosage forms.
II) Discuss about documents prepared for pilot plant scale up.
III) Describe the change in component and composition for Immediate release solid dosage forms as per SUPAC guidelines.
I) Discuss considerations for premises and equipments in context of transfer of from R & D to production scale.
I) Write a note on management of clinical studies.
II) Discuss the non-clinical drug development process.
III) Discuss the roles and responsibilities of drug development team.
II) Explain all the sequential steps of quality risk management.
III) Which information must be provided from sender unit to receiver unit in context of API as per WHO guidelines of technology transfer?
I) Write full form of the following abbreviations and define them as per WHO guideline on transfer of technology:
a. IQ, b. OQ, C. PQ, d. IPC and e. SOP
II) What do you mean by transfer of technology? Enlist reasons for need of technology transfer?
III) Discuss responsibilities of regulatory affairs professionals.
I) Write short note on (a) Cause-and-effect diagram and (b) Pareto diagram.
II) Discuss the scope and types of change control in pharmaceutical industries.
III) What is ISO 9000? Describe ISO 9000 series of standards.
1. What is pilot plant scale up? Discuss the significance and requirements for scale up of pharmaceutical product from R and D to plant.
2. What do you mean by the term “Technology Transfer”? Discuss in detail about WHO guidelines for technology transfer.
3. Define the term “Regulatory Affairs”. Discuss about role of regulatory affairs department and responsibility of regulatory affairs professionals.
4. Discuss the concept of quality, total quality management and Quality by Design (QbD).
5. Give a detailed account on regulatory requirements and approval procedures for new drug.
6. Discuss general considerations of Investigational New Drug(IND) Application. Explain the role of biostatistics in pharmaceutical product development.
7. Discuss in detail about ISO 9000 and ISO 14000 series of quality systems standards.
8. Write short notes on any three of the following:
a) Technology transfer agencies in India
b) SUPAC guidelines
c) Six Sigma concept
d) Management of clinical studies