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) — extracted question text · 75 marks · 3 Hours
Section AAttempt all questions in brief. 10 x 2 = 20
- aExplain in brief about confide ntial agreement checklist
- bEnumerate the connection of re gulatory affairs department wi th other department in company
- cWhat are the steps involving in Scale- up?
- dMention the various contents of technology transfer dossier
- eMention the dimensions of Quality
- fExplain in brief about NABL and its scope
- gShort note on Six Sigma Concept and its levels
- hEnlist 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
- aDescribe the organization a nd functions of Central drug regulatory Authority in India
- bWhat are Bioequivalence studi es and Biowaivers? Describe in detail
- cDefine 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
- aExplain QBD in detail. Discuss its importance in pharmaceuticals
- bDescribe in detail about general considerations of Investiga tional New drug (IND) application
- cWhat is quality risk manageme nt? Explain QRM process along with its tool
- dExplain the types and methods of technology transfer
- eExplain the modules of CTD in detail
- fExplain in detail the section that deals with changes in exc ipient in the drug product as per SUPAC guideline
- gWhat are the steps in obtai ning ISO 9000 series certifications?
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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