2. Explain in detail the section that deals with changes in excipient in the drug product
3. What are SUPAC guidelines? What is the purpose of these guidelines? Explain the
contents of SUPAC guidelines in short.
1. Explain evolution and purpose of SUPAC guidelines.
2. Define the following as per SUPAC guidelines
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.
c. Recommend chemistry, manufacturing and control tests
2. The changes that are likely to have significant impact on quality and performance
3. How many types of changes that SUPAC guidelines deal with
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
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?
c. SUPAC-SS d. All of the above
7. SUPAC guidelines are issued by
8. A series of operations and/or actions used to produce a desired result is known as
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
11. SUPAC task force is established by
a. Antibiotic agents drug approval
b. Antibiotics agonists drug approval
c. Antibiotics application for drug approval
d. Abbreviated antibiotic drug applications
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
14. Mention the changes (as per SUPAC guidelines) to which the following
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.
1. d 2. c 3. b 4. b 5. a 6. d 7. b 8. b
13. (a) Level 1, (b) 10, (c) Changes, USFDA, (d) Platform
14. (a) Level 1, change in composition and components,
(c) Level 2, change in composition and components,
(d) Level 3, change in composition and components,
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