50 MCQs on Pilot Plant Scale-Up Techniques and SUPAC Guidelines

1. What is the main purpose of a pilot plant?

a) To skip laboratory studies

b) To validate commercial-scale production directly

c) To develop viable manufacturing procedures

d) To avoid stability testing

Answer: c

2. What does scale-up in industrial pharmacy involve?

a) Transition from R&D to production scale

b) Direct marketing

c) Eliminating laboratory trials

d) Changing formulation without trials

Answer: a

3. Which of the following is NOT an objective of pilot plant studies?

a) Identifying critical process features

b) Optimizing equipment size

c) Avoiding regulatory approvals

d) Ensuring dosage stability

Answer: c

4. Why are pilot plant studies critical?

a) They skip R&D efforts

b) They assess full-scale production impact

c) They eliminate the need for product testing

d) They avoid documentation

5. What is the first step in scale-up?

a) Conducting stability studies

b) Designing the plant layout

c) Defining product economics

d) Validating cleaning procedures

Answer: c

6. Which general consideration involves ensuring sufficient workspace?

a) Reporting responsibility

b) Personnel requirements

c) Space requirements

d) Equipment selection

Answer: c

7. Who should ideally be part of the pilot plant team?

a) Only engineers

b) Scientists with manufacturing experience

c) Sales and marketing staff

d) Clinical trial experts

Answer: b

8. Which blending equipment is commonly used in pilot plants?

a) Ribbon blender

b) Fluidized bed dryer

c) Hammer mill

d) Sigma blade mixer

Answer: a
9. Which parameter is critical for evaluating drying efficiency?

a) Moisture content

b) Die cavity size

c) Capsule type

d) Granulation sequence

Answer: a

10. What is the purpose of master manufacturing procedures?

a) To summarize annual production

b) To provide clear instructions for batch production

c) To eliminate regulatory requirements

d) To evaluate market response

Answer: b

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