B.PharmSemester 72024-25Industrial Pharmacy IiBP702T
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Industrial Pharmacy Ii (BP702T) - AKTU Question Paper 2024-25

B.Pharm · Semester 7 · Free PDF Download

This is the official AKTU Industrial Pharmacy Ii Previous Year Question Paper for B.Pharm Semester 7, academic session 2024-25. Published by Dr. A.P.J. Abdul Kalam Technical University (AKTU/UPTU), Lucknow. Free PDF download — no login required.

Course:B.Pharm
Semester:Semester 7
Session:2024-25
University:AKTU / UPTU

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Questions Asked in 2024-25

Industrial Pharmacy Ii (BP702T) — complete question paper · 75 marks · 3 Hours

Section AAttempt all questions in brief. 10 x 2 = 20
  • a
    Explain in brief about confide ntial agreement checklist
  • b
    Enumerate the connection of re gulatory affairs department wi th other department in company
  • c
    What are the steps involving in Scale- up?
  • d
    Mention the various contents of technology transfer dossier
  • e
    Mention the dimensions of Quality
  • f
    Explain in brief about NABL and its scope
  • g
    Short note on Six Sigma Concept and its levels
  • h
    Enlist the reasons for occurre nce of OOS (Out of specifications). i. Enlist the principles a nd key elements of TQM. j. Explain in brief about application of Biostatistics in pharm aceutical product development
Section BAttempt any two parts of the following: 2 x 10 = 20
  • a
    Describe the organization a nd functions of Central drug regulatory Authority in India
  • b
    What are Bioequivalence studi es and Biowaivers? Describe in detail
  • c
    Define pilot-plant and relati on between pilot-plant and scal e -up. Describe pilot-plant scale -up considerations for solids in detail
Section CAttempt any five parts of the following: 7 x 5 = 35
  • a
    Explain QBD in detail. Discuss its importance in pharmaceuticals
  • b
    Describe in detail about general considerations of Investiga tional New drug (IND) application
  • c
    What is quality risk manageme nt? Explain QRM process along with its tool
  • d
    Explain the types and methods of technology transfer
  • e
    Explain the modules of CTD in detail
  • f
    Explain in detail the section that deals with changes in exc ipient in the drug product as per SUPAC guideline
  • g
    What are the steps in obtai ning ISO 9000 series certifications?

Question text is extracted from the official AKTU question paper PDF above. Hindi translations are omitted — every question is printed in English in the original paper. Last verified: 2026-08-23.

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