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) — extracted question text
Section AAttempt all questions in brief. 10 x 2 = 20
- aName the participants of ICH
- bDifferentiate QA and QC
- cName the Ancillary areas
- eWhat is Cobb’s test?
- fWhat refer to the subpart K in GLP?
- hOutline 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
- aExplain ISO14000: overview, benefits, elements and steps of registration
- bDiscuss Design, construction and plant layout along with maintenance of organization premises in detail
- cDefine 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
- aDescribe in detail ICH Guidelines: purpose, process of harmonization, overview of QSEM and Q-series Guidelines
- bWrite short note Definition, elements, philosophies of Total Quality Management (TQM)
- cWrite short note on: (i) Quality control tests for Plastic Containers (ii) Quality control tests for Metal Containers
- dDiscuss purchase specifications and maintenance of stores for raw materials
- eDiscuss about Protocol for conduct of Non-Clinical Laboratory study
- fExplain in detail about Master Formula Record and SOP
- gElaborate 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. Check the original PDF for equations, diagrams and complete wording. Extracted: 2026-08-23.
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