B.PharmSemester 72021-22Industrial Pharmacy IiBP-702T

Industrial Pharmacy Ii (BP-702T) - AKTU Question Paper 2021-22

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 2021-22. 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:2021-22
University:AKTU / UPTU

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Questions Asked in 2021-22

Industrial Pharmacy Ii (BP-702T) — extracted question text

Section AAttempt all q u e s t i o n s i n b r i e f . 10 x 2 = 20
  • a
    Mention two major appli cations of platform technology
  • b
    Mention the basic role of SUPAC guidelines
  • c
    Name at least 4 agencies responsible for successful technolo gy transfer in India
  • d
    State the role of one maj or TT agency of India
  • e
    State to important functions of the Regulatory Affairs Department
  • f
    What do you mean by ‘Non-Clin ical Drug Development’?
  • g
    What do you mean by ‘Six Sigma concept,’?
  • h
    Mention the specifications of ISO 14000 series of quality systems standards. i. State the responsib ilities of CDSCO. j. Mention the signi ficance of COPP
Section BAttempt any two p a r t s o f t h e f o l l o w i n g : 2 x 10 = 20
  • a
    State and explain the Technol ogy transfer protocol following WHO guidelines
  • b
    Describe the steps of data pres entation for FDA Submissions
  • c
    Give a brief idea on regulat ory requirements and approval procedures for new drugs
Section CAttempt any five p a r t s o f t h e f o l l o w i n g : 7 x 5 = 35
  • a
    Explain the significance of pe rsonnel requirements in pilot plant scale up
  • b
    Describe the steps for tec hnology transfer from RD to production
  • c
    State and explain the lega l issues during technology development and transfer
  • d
    Explain the responsibilities of the regulatory affairs professionals
  • e
    Define clinical research a nd state the clinical research protocols
  • f
    Write a brief note on the c oncept of Quality by Design (QbD)
  • g
    Describe the functionalities of the Central Drug Standard Control

Question text is extracted from the official AKTU question paper PDF above. Check the original PDF for equations, diagrams and complete wording. Extracted: 2026-08-23.

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