Industrial Pharmacy–II (7th Semester) – Question Paper
4
Time: 3 Hours
Maximum Marks: 75
Q.1 MCQs [20 × 1 = 20 marks]
(Attempt all)
1. SUPAC guidelines are primarily for:
a) Post-approval formulation or process changes
b) Clinical trial design
c) Marketing strategy
d) Packaging selection
2. Pilot plant scale-up helps in:
a) Reducing regulatory submissions
b) Scaling lab formulation to production batches
c) Distribution planning
d) Cost analysis only
3. QbD is based on:
a) Random trials
b) Process understanding and risk assessment
c) Marketing needs
d) Cost reduction
4. BMR documents:
a) Marketing plan
b) Batch manufacturing steps, raw materials, and specifications
c) Clinical trial results
d) Packaging approvals
5. In-process quality control includes:
a) Weight variation
b) Hardness test
c) Friability
d) All of the above
6. The Japanese regulatory authority is:
a) FDA
b) EMA
c) PMDA
d) WHO
7. Retrospective validation is performed:
a) On historical production batches
b) During lab formulation
c) On pilot plant batches only
d) During clinical trials
8. Technology transfer is:
a) Only equipment transfer
b) Transfer of knowledge, process, and technology from R&D to production
c) Marketing transfer
d) Packaging transfer
9. Critical Process Parameters (CPP) affect:
a) Critical Quality Attributes (CQA)
b) Marketing cost
c) Distribution plan
d) Packaging
10. Shelf life determination is part of:
a) Stability studies
b) Pilot plant studies
c) Technology transfer
d) Packaging evaluation
11. SUPAC–IR applies to:
a) Immediate release dosage forms
b) Modified release dosage forms
c) Injectable dosage forms
d) Oral liquids
12. Prospective validation is performed:
a) Before commercial production
b) During production
c) After product release
d) On pilot batches only
13. Revalidation is necessary:
a) When significant process changes occur
b) Never
c) Only on lab batches
d) For marketing approval
14. Granularity in technology transfer refers to:
a) Level of detail in process documentation
b) Particle size
c) Marketing plan
d) Packaging information
15. CPP is monitored using:
a) In-process checks
b) Market survey
c) Sales data
d) Packaging audit
16. R&D batch is different from production batch in:
a) Batch size and equipment scale
b) Packaging only
c) Labeling only
d) Sales plan
17. ICH Q8 deals with:
a) Pharmaceutical Development
b) Technology Transfer
c) Quality Risk Management
d) Regulatory Affairs
18. Pilot plant study does NOT include:
a) Process optimization
b) Equipment assessment
c) Marketing evaluation
d) Formulation trials
19. Purpose of QRM is:
a) Minimize risk to product quality
b) Reduce cost only
c) Approve vendors
d) Marketing evaluation
20. Technology transfer documentation includes:
a) SOPs
b) Batch records
c) Validation reports
d) All of the above
Q.2 Long Answer Questions [3 × 10 = 30 marks]
(Attempt any two)
1. Discuss scale-up considerations for tablet dosage forms, including
equipment, parameters, and challenges.
2. Explain Technology Transfer – types, documentation, and significance.
3. Write a detailed note on Quality by Design (QbD) and its application in
industrial pharmacy.
Q.3 Short Answer Questions [9 × 5 = 45 marks]
(Attempt any seven)
1. Define pilot plant and its objectives.
2. Write a short note on SUPAC–MR guidelines.
3. Explain Critical Quality Attributes (CQAs).
4. Differentiate between R&D batch and production batch.
5. Write short note on In-process Quality Control (IPQC).
6. Explain Granularity in technology transfer process.
7. Write a note on ICH Q9 guideline.
8. Define Design Space in QbD.
9. List the types of process validation.