B.Pharma Important Question
BP-702T,
Industrial Pharmacy-II,
VII Sem, RGPV, B.Pharmacy
UNIT-I Pilot Plant Scale up Techniques
Q.1 Discuss the general factors to be considered in pilot plant scale up technology. (RGPV Dec 2024)
Q.2 Discuss pilot plant scale-up consideration for semi-solids. (RGPV Dec 2024)
Q.3 How analytical methods are exchanged in a technology transfer? (RGPV Dec 2024)
Q.4 Explain Pilot Plant Scale up for Solids and relevant documents. (RGPV Nov 2023)
Q.5 Briefly discuss about Platform Technology (RGPV Nov 2023)
Q.6 What is pilot plant scale up? Discuss the significance and requirements for scale up of pharmaceutical product from R and D to plant. (RGPV Jun 2020)
UNIT-II Technology Development and Transfer
Q.1 Discuss the granularity of TT process (API, recipients, finished products, packaging material) as per WHO guidelines for TT. (RGPV Dec 2024)
Q.2 Discuss documentation, premises and equipment for TT as per WHO guidelines. (RGPV Dec 2024)
Q.3 Discuss technology transfer from R&D to production as per WHO guidelines. (RGPV Dec 2024)
Q.4 Explain WHO Guidelines for Technology Transfer. (RGPV Nov 2023)
Q.5 Write a Short note on APCTD and NRDC. (RGPV Nov 2023)
Q.6 What do you mean by the term “Technology Transfer”? Discuss in detail about WHO guidelines for technology transfer. (RGPV Jun 2020)
UNIT-III Regulatory Affairs
Q.1 Explain Regulatory Requirement Approval for obtaining NDA. (RGPV Dec 2024)
Q.2 Write a note on a clinical Research protocol. (RGPV Dec 2024)
Q.3 Write a note on the Investigator’s Brochure (IB). (RGPV Dec 2024)
Q.4 Discuss Historical overview of Regulatory Affairs. (RGPV Nov 2023)
Q.5 Explain Investigational New Drug (IND) in detail. (RGPV Nov 2023)
Q.6 Explain New Drug Application (NDA) in detail. (RGPV Nov 2023)
Q.7 Discuss about Investigator’s Brochure (IB). (RGPV Nov 2023)
Q.8 What is Clinical Research protocol? (RGPV Nov 2023)
Q.9 What is the role of Regulatory Affairs Department? (RGPV Nov 2023)
Q.10 Define the term “Regulatory Affairs”. Discuss about role of regulatory affairs department and responsibility of regulatory affairs professionals. (RGPV Jun 2020)
Q.11 Discuss general considerations of Investigational New Drug (IND) Application. Explain the role of biostatistics in pharmaceutical product development. (RGPV Jun 2020)
UNIT-IV Quality Management Systems
Q.1 What is (RGPV Dec 2024)
- a) Six Sigma Concept
- b) Out of Specification (OOS)
- c) Change Control
Q.2 Define Quality Management. Write a note on Total Quality Management (TQM). (RGPV Dec 2024)
Q.3 Write a note on: (RGPV Dec 2024)
a) QBD
b) NABL
c) GLP
Q.4 Explain Quality Risk Management and Technology Transfer Protocol. (RGPV Nov 2023)
Q.5 Explain Six Sigma concept in detail. (RGPV Nov 2023)
Q.6 Write a Short note on GLP and NABL. (RGPV Nov 2023)
Q.7 Briefly discuss about ISO 9000 series. (RGPV Nov 2023)
Q.8 Discuss the concept of quality, total quality management and Quality by Design (QBD). (RGPV Jun 2020)
Q.9 Discuss in detail about ISO 9000 and ISO 14000 series of quality systems standards. (RGPV Jun 2020)
UNIT-V Indian Regulatory Requirements
Q.1 Explain the Organization and Responsibilities of the State Licensing Authority in India. (RGPV Dec 2024)
Q.2 Explain CDSCO in detail. (RGPV Nov 2023)
Q.3 Explain Certificate of Pharmaceutical Product in detail. (RGPV Nov 2023)
Q.4 Give a detailed account on regulatory requirements and approval procedures for new drug. (RGPV Jun 2020)
Extra Questions
Q.1 Discuss the various Modules in CTD. (RGPV Dec 2024)
Q.2 Write short notes on any three of the following: (RGPV Jun 2020)
a) Technology transfer agencies in India
b) SUPAC guidelines
c) Six Sigma concept
d) Management of clinical studies
— Best of Luck for Exam —
