B.PharmSemester 62022-23Quality AssuranceBP-606T

Quality Assurance (BP-606T) - AKTU Question Paper 2022-23

B.Pharm · Semester 6 · Free PDF Download

This is the official AKTU Quality Assurance Previous Year Question Paper for B.Pharm Semester 6, academic session 2022-23. Published by Dr. A.P.J. Abdul Kalam Technical University (AKTU/UPTU), Lucknow. Free PDF download — no login required.

Course:B.Pharm
Semester:Semester 6
Session:2022-23
University:AKTU / UPTU

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Questions Asked in 2022-23

Quality Assurance (BP-606T) — complete question paper

Section AAttempt all questions in brief. 10 x 2 = 20
  • a
    Name the participants of ICH
  • b
    Differentiate QA and QC
  • c
    Name the Ancillary areas
  • e
    What is Cobb’s test?
  • f
    What refer to the subpart K in GLP?
  • h
    Outline the role of recalling. (i) Give importance and scope of validation. (j) Discuss general principles of qualification
Section BAttempt any two parts of the following: 2 x 10 = 20
  • a
    Explain ISO14000: overview, benefits, elements and steps of registration
  • b
    Discuss Design, construction and plant layout along with maintenance of organization premises in detail
  • c
    Define calibration. Elaborate general principles of calibration, qualification and validation, types of validation along with validation master plan
Section CAttempt any five parts of the following: 7 x 5 = 35
  • a
    Describe in detail ICH Guidelines: purpose, process of harmonization, overview of QSEM and Q-series Guidelines
  • b
    Write short note Definition, elements, philosophies of Total Quality Management (TQM)
  • c
    Write short note on: (i) Quality control tests for Plastic Containers (ii) Quality control tests for Metal Containers
  • d
    Discuss purchase specifications and maintenance of stores for raw materials
  • e
    Discuss about Protocol for conduct of Non-Clinical Laboratory study
  • f
    Explain in detail about Master Formula Record and SOP
  • g
    Elaborate method of Qualification of UV-Visible spectrophotometer andGeneral principles of Analytical method Validation

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.

Repeated Questions — BP-606T

Questions that appeared in more than one session, found by comparing 2 years of Quality Assurance papers (2022-23, 2024-25)

2x

Discuss about Protocol for conduct of Non-Clinical Laboratory study

Appeared in: 2022-23 · 2024-25

Quality Assurance — Other Year Papers

AKTU Quality Assurance PYQs from other sessions