Industrial Pharmacy 2 Important Questions with Answers (Unit-wise, BP702T)

By Vignesh, Pharma Graduate · Member of LBP · Updated November 2026

Industrial Pharmacy II is the Semester 7 paper students search for the most, and for good reason. It is less about memorising formulas and more about writing structured answers on pilot plants, technology transfer, regulatory approvals and quality systems. The good news: the same questions come back year after year.

Below are the Industrial Pharmacy 2 important questions, unit-wise, based on the PCI 2016-17 syllabus (BP702T). We have marked the most-asked ones with ★, added two sample answers in exam format and five practice MCQs so you can test yourself.

Want every answer written out? The Industrial Pharmacy II Exam Pack has model answers for all the ★ questions. Just ₹49. See the pack →

Industrial Pharmacy II exam pattern (BP702T)

Section	Questions	Marks
I. Objective (MCQs / fill in the blanks / one-word)	10 × 2 (or 20 × 1)	20
II. Long answers	Answer 2 of 3 × 10	20
III. Short answers	Answer 7 of 9 × 5	35
Total	3 hours	75

Long answers carry 10 marks, so one well-structured pilot plant or regulatory answer is worth as much as two short notes. Write definition → objectives → steps or flow chart → guidelines → advantages.

Industrial Pharmacy II important questions, unit-wise

★ marks the questions asked most often in university papers. Prepare these first.

Unit I: Pilot plant scale-up techniques

Long (10 marks)

• ★ Define pilot plant. Explain the general considerations (personnel, space, raw materials, equipment, process evaluation, GMP, master manufacturing procedures) and the scale-up of tablets.
• ★ Discuss the pilot plant scale-up of liquid orals and semisolids.

Short (5 marks)

• ★ SUPAC guidelines · Objectives of a pilot plant · Scale-up of capsules · Platform technology (introduction)

Unit II: Technology transfer

Long

• ★ Define technology transfer. Describe the WHO guidelines: transfer from R&D to production (process, packaging, cleaning), granularity of transfer, and documentation.

Short

• ★ Technology transfer agencies in India: APCTD, NRDC, TIFAC, BCIL, TBSE/SIDBI · Technology transfer protocol (TTP) · Quality risk management in transfer
• Legal issues: confidentiality agreements, licensing, MoUs

Unit III: Regulatory affairs

Long

• ★ Explain the drug development process and the regulatory requirements for IND, NDA and ANDA (US FDA).
• Describe the role of the regulatory affairs department and the responsibilities of a regulatory affairs professional.

Short

• ★ Clinical trial phases · Non-clinical (preclinical) drug development · Bioequivalence studies · Clinical research protocols
• Biostatistics in product development · Data presentation for FDA submission · Management of clinical studies

Unit IV: Quality management systems

Long

• ★ Explain the concept of quality. Discuss total quality management (TQM) and quality by design (QbD).

Short

• ★ Six Sigma (DMAIC) · OOS (out of specification) investigation · Change control · ISO 9000 and ISO 14000 · NABL accreditation · GLP

Unit V: Indian regulatory requirements

Short

• ★ CDSCO: organisation and responsibilities · Certificate of pharmaceutical product (CoPP) · Regulatory requirements and approval procedure for new drugs in India (New Drugs and Clinical Trials Rules 2019)

Sample model answers

Here are 2 answers written the way examiners like them. The pack has model answers for every ★ question.

SUPAC guidelines (5 marks)

SUPAC (Scale-Up and Post-Approval Changes): US FDA guidelines describing what documentation and tests are needed when changes are made to an approved product after approval (to components and composition, site of manufacture, batch size (scale-up / scale-down), manufacturing equipment and process).

Guidelines:

• SUPAC-IR (1995): immediate-release solid oral dosage forms.
• SUPAC-MR (1997): modified-release solid oral dosage forms.
• SUPAC-SS (1997): non-sterile semisolid dosage forms.
• SUPAC-IR/MR: equipment addendum (1999).

Levels of change:

Level	Likely effect on quality and performance	Requirement
Level 1	Unlikely to have any detectable impact	Annual report (minimal testing)
Level 2	Could have a significant impact	Changes being effected (CBE) supplement; dissolution profiles, stability data (e.g. 3 months accelerated on 1 batch)
Level 3	Likely to have a significant impact	Prior approval supplement (PAS); stability, dissolution, and possibly a bioequivalence study

Examples (SUPAC-IR):

• Batch size: an increase up to 10 times the pilot batch is Level 1; more than 10 times is Level 2.
• Site change: within the same facility (Level 1), within the same campus (Level 2), to a different campus (Level 3).
• Equipment change: same design and principle (Level 1); different design and principle (Level 2).
• Excipient change: small changes within limits, e.g. filler ±5%, disintegrant (starch) ±3%, binder ±0.5%, lubricant (Mg stearate) ±0.25%, glidant (talc) ±1% (Level 1).

Benefits: reduce the regulatory burden, speed up changes, give consistent review criteria, and ensure the quality and performance of the changed product.

Six Sigma (5 marks)

Six Sigma: a data-driven methodology for reducing variation and defects in processes. Developed by Motorola (Bill Smith, 1986) and popularised by General Electric (Jack Welch).

• Sigma (σ) is the standard deviation. A Six Sigma process produces no more than 3.4 defects per million opportunities (DPMO) (allowing for a 1.5σ shift of the process mean).

Sigma level	DPMO	Yield
3σ	66,807	93.3%
4σ	6,210	99.38%
5σ	233	99.977%
6σ	3.4	99.99966%

Methodologies:

• DMAIC (for improving existing processes):
  1. Define: the problem, the project goals and the customer requirements (CTQ: critical to quality); project charter; SIPOC.
  2. Measure: the current performance (data collection, process capability, measurement system analysis).
  3. Analyse: identify the root causes of defects (fishbone diagram, Pareto analysis, 5 Whys, hypothesis testing, regression).
  4. Improve: develop and test solutions (DoE, pilot implementation).
  5. Control: sustain the improvement (control charts, SPC, SOPs, training).
• DMADV / DFSS (Design for Six Sigma) (for new processes or products): Define, Measure, Analyse, Design, Verify.

Roles (belts): Champion (senior management sponsor), Master Black Belt (coach), Black Belt (full-time project leader), Green Belt (part-time), Yellow Belt (team members).

Lean Six Sigma combines Lean (removing waste: the 8 wastes, e.g. waiting, overproduction, defects, inventory, motion, transport, over-processing, unused talent) with Six Sigma (reducing variation).

Applications in pharma: reducing batch failures, tablet weight variation, OOS results, deviations, cycle time, documentation errors and complaints; improving yields and laboratory turnaround.

5 practice MCQs with answers

1. A pilot batch for a solid oral dosage form should be at least:

• a) 1% of the commercial batch
• b) 10% of the commercial batch or 100,000 units, whichever is larger
• c) 50% of the commercial batch
• d) 1000 units

Show answer

Answer: b. This makes it representative of production.

2. The granulation end point in a high-shear mixer is commonly monitored by:

• a) Power consumption (torque)
• b) pH
• c) Temperature only
• d) Colour

Show answer

Answer: a. It reflects the wet mass consistency.

3. Over-mixing with magnesium stearate during lubrication causes:

• a) Decreased hardness and slower dissolution
• b) Increased disintegration speed
• c) Better flow only
• d) Increased hardness

Show answer

Answer: a. Its hydrophobic film coats the granules.

4. SUPAC-IR applies to:

• a) Semisolids
• b) Immediate-release solid oral dosage forms
• c) Modified-release dosage forms
• d) Parenterals

Show answer

Answer: b. SUPAC-MR: modified release; SUPAC-SS: semisolids.

5. Under SUPAC, a change likely to have a significant impact on quality requires a:

• a) Prior approval supplement
• b) No documentation
• c) Annual report
• d) Changes being effected supplement

Show answer

Answer: a. It is a Level 3 change.

Free Industrial Pharmacy 2 notes, unit-wise

• Unit 1: Pilot plant scale-up
• Unit 2: Technology transfer
• Unit 3: Regulatory affairs
• Unit 4: Quality management systems
• Unit 5: Indian regulatory requirements

Frequently asked questions

Which unit is most important in Industrial Pharmacy 2?

Unit I (pilot plant scale-up) and Unit III (IND, NDA, ANDA and the drug development process) supply most of the 10-mark questions. Unit IV gives frequent 5-mark notes on Six Sigma, OOS, change control and ISO.

Is Industrial Pharmacy 2 a scoring subject?

Yes. It is theory-based and repetitive. If you can write SUPAC, technology transfer, IND/NDA/ANDA, QbD and CDSCO well, you cover most of the paper.

How many questions should I attempt in the Industrial Pharmacy 2 paper?

In the 75-mark pattern you answer all objective questions, 2 of 3 long answers and 7 of 9 short answers. Pick the long answers you can draw a flow chart for.

Is this based on the PCI syllabus?

Yes, it follows the PCI B.Pharm 2016-17 syllabus for BP702T. Check your university’s question paper pattern, as a few universities use a different marks split.