INDUSTRIAL PHARMACY-2(B pharm 7 sem) question bank

B pharmacy 7 semester INDUSTRIAL PHARMACY Questions bank:


2 MARKS Questions

  1. Define pilot and scale up?
  2. What is the difference between pilot scale and scale-up?
  3. Why to conduct pilot plant studies?
  4. What are the advantages of pilot studies?
  5. What is SUPAC?
  6. What is the purpose of SUPAC guidelines?
  7. Define platform technology?

5 MARKS short Assay

  1. What are the objectives and significance of pilot plants?
  2. Explain SUPAC guidelines?
  3. Discuss the uses of platform technology?

10 MARKS Long Assay

  1. Discuss the general factors to be considered in pilot plant scale up technology?
  2. Discuss pilot plant scale up consideration for solids dosage solids.
  3. Discuss pilot plant scale up consideration for liquid orals.
  4. Discuss pilot plant scale up consideration for semi-solids.
  5. what are difference platform technology and explain.



  1. Define the technology transfer according to WHO and how it is classified?
  2. What are the goal of technology transfer?
  3. What are the advantage of technology transfer?
  4. What is good manufacturing practices (GMP)?
  5. What do you mean by SU &RU
  6. Define quality risk management (QRM) and write its principle
  7. What do you mean by intercompany and intracompany?
  8. What is standard operating procedure (SOP) ?
  9. What is validation and process validation?
  10. What is validation protocol (VP) and validation report (VR) ?
  11. what is the drug master file (DMF) ?
  12. What is analytical method transfer?
  13. What is design qualification (DQ) and installation qualification ( IQ) ?
  14. What is operational qualification (OQ) and performance qualification (PQ) ?


  1. Explain technology transfer sample protocol in pharmaceuticals
  2. Discuss technology transfer from R & D to production as per WHO guidelines?
  3. Discuss granularity of TT process (API, excipients, finished products, packaging material) as per WHO guidelines for TT ?
  4. Discuss about documentation, premises, and equipments for TT as per WHO guidelines
  5. Discuss about qualification and validation for TT as per WHO guidelines?
  6. How analytical methods are exchanged in a technology transfer ?


  1. Discuss stage involved in TT in pharmaceutical industry?



  1. What is regulatory affairs ? what its goal?
  2. what is investigational new drug and application?
  3. what is New drug application (NDA) /
  4. what is clinical trial?
  5. what is clinical trial protocol?
  6. what are BE & BA studies? why they are required?
  7. Mention the major regulatory bodies in the world?
  8. What is the organisational structure of regulatory affairs ?
  9. Which is the health care product regulated by RA ?
  10. What is CTD ?


  1. Discuss the role and responsibilities of RA professional.
  2. Write a note on Drug development team and their functions.
  3. Discuss regulatory authorities and their responsibilities.
  4. Write a note on Non-clinical drug development process.
  5. Write a note on Investigator’s Brochure (IB).
  6. Discuss the different phase of clinical trial.
  7. How Bioequivalence are documented.
  8. Write a note on clinical Research protocol.
  9. Discuss about Management of clinical studies.
  10. Discuss the various Modules in CTD.


  1. Explain Regulatory Requirement Approval for obtaining NDA.
  2. Discuss general consideration of Investigational New drug Application.

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