Short Answer Type Questions

1. Explain the following with respect to general “considerations”

a. Reporting responsibilities

b. Space requirements

c. Review of the formula

d. Process evaluation

2. Explain preparing of master manufacturing procedures.

3. What are the types of oral liquids?

4. Explain different steps in liquid manufacturing process.

5. What is the importance of documentation during pilot-plant scale-up process?

Objective Type Questions

1. Which of the following items of GMP are to be considered under general

consideration?

a. Reporting responsibilities b. Space requirements

c. Equipment d. All of the above

24 Industrial Pharmacy II

2. Which of the following items of GMP are to be considered under GMP

consideration?

a. Validation b. Equipment qualification

c. Training d. All of the above

3. Storage area and physical testing area requirements comes under which of the

following general considerations?

a. Equipment b. Production rate

c. Space requirements d. None of the above

4. Product loss data during using a specific equipment and process comes order

which of the following general considerations?

a. Process evaluation b. Raw material

c. Production rate d. Transfer of analytical methods to QA