2. Explain in detail the section that deals with changes in excipient in the drug product

as per SUPAC guidelines.

3. What are SUPAC guidelines? What is the purpose of these guidelines? Explain the

contents of SUPAC guidelines in short.

Short Answer Type Questions

1. Explain evolution and purpose of SUPAC guidelines.

2. Define the following as per SUPAC guidelines

i. Batch ii. Equipment

iii. Drug product iv. Formulation

v. New drug substance vi. Validation

3. Explain different levels of changes under SUPAC guidelines.

4. Describe the type of changes under SUPAC guidelines.

5. What is the platform technology? Explain with an example.

Objective Type Questions

1. SUPAC guidelines deal with

a. Level of changes

b. Filing documentation

c. Recommend chemistry, manufacturing and control tests

d. All of the above

2. The changes that are likely to have significant impact on quality and performance

of formulations are

a. Level 2 b. Level 1

c. Level 3 d. Level 4

3. How many types of changes that SUPAC guidelines deal with

a. 1 b. 4

c. 2 d. 5

4. High permeability and high solubility drugs are if having

a. Dissolution of 75% in 20 min b. Dissolution of 85% in 15 min

c. Dissolution of 70% in 5 min d. Dissolution of 95% in 20 min

5. What does SUPAC stand for?

a. Scale-up and post-approval changes

b. South-western plant authorities

c. Scale-up and pre-approval changes

d. Scale-up and post-accreditation changes

6. Which of the following is a guidance document issued by USFDA regarding

SUPAC to guide industries regarding changes?

a. SUPAC-IR b. SUPAC-MR

c. SUPAC-SS d. All of the above

7. SUPAC guidelines are issued by

a. ICH b. USFDA

c. WHO d. None of the above

40 Industrial Pharmacy II

8. A series of operations and/or actions used to produce a desired result is known as

a. Pilot scale b. Process

c. Operating principles d. Scale-up

9. Change in the excipient (disintegrated) in which of the following percent ranges

comes under level 1, change in composition and component

a. 3% (starch), 2% (other) b. 2% (starch), 3% (other)

c. 3% (starch), 1% (other) d. None of the above

10. A group of technology which acts as a base upon which various other technologies,

process, applications can be developed is known as

a. Information technology b. Platform technology

c. Process d. Scale-up

11. SUPAC task force is established by

a. CDSCO b. CDER

c. WHO d. WTO

12. AADA stands for

a. Antibiotic agents drug approval

b. Antibiotics agonists drug approval

c. Antibiotics application for drug approval

d. Abbreviated antibiotic drug applications

13. Fill in the blanks

a. _______________ are the changes that are unlikely to have any impact, i.e.

detectable in nature or quality or performance of formulations.

b. The ____________ percentage change in filler concentration comes under level 2

of change in composition and control.

c. SUPAC guidelines are guidance document on ____________ issued by __________.

d. Immunotherapy platform for treating a range of cancer is an example of

__________ technology.

14. Mention the changes (as per SUPAC guidelines) to which the following

statements belongs

a. Changes in colour or flavour of the formulation or change in the printing ink.

b. The changes of manufacturing site between facilities in adjacent city block/

campus and other related factor kept constant.

c. Changes in technical grade of an excipient.

d. The changes in which the drug is not meeting dissolution criteria of level 2 changes.

e. Change from non-mechanical or non-automated equipment to an automated

equipment to move ingredients.

ANSWERS

1. d 2. c 3. b 4. b 5. a 6. d 7. b 8. b

9. c 10. b 11. b 12. d

13. (a) Level 1, (b) 10, (c) Changes, USFDA, (d) Platform

14. (a) Level 1, change in composition and components,

(b) Level 2, site changes,

(c) Level 2, change in composition and components,

(d) Level 3, change in composition and components,

(e) Level 1, changes in manufacturing.

PLANT