ICH, USFDA, WHO, ISO, CDSCO, BIS, OECD, MHRA, TGA
TOP 10 MCQ
1. Which of the following climatic zones can be categorized into the hot & dry zone: [GPAT 2024]
(a) Zone I
(b) Zone III
(c) Zone IV
(d) Zone II
2. Which of the following Climatic Zones (as per WHO criteria) refers to “Hot and Humid climate”? [GPAT 2023 Shift I]
(a) Zone I
(b) Zone II
(c) Zone III
(d) Zone IV
3. Which of the following ICH Harmonized Tripartite Guidelines related to stability provides the general requirements for stability testing of new drug substances and products? [GPAT 2023 Shift II]
(a) Q1A (R2)
(b) Q1B
(c) Q1D
(d) Q1E
4. The “Up and Down” method for a projected LD₅₀ determination is described in the: [GPAT 2022]
(a) OECD Guideline 401
(b) OECD Guideline 420
(c) OECD Guideline 423
(d) OECD Guideline 425
5. Which of the following ICH Harmonized Tripartite Guidelines related to stability provides approaches that allow for bracketing and matrixing designs for stability testing? This is especially important when a new drug product is to be commercialized with multiple strengths in multiple packaging configurations. [GPAT 2021]
(a) Q1F
(b) Q1D
(c) Q1B
(d) Q1A
6. In International Organization for Standardization (ISO), the standard pertaining to quality system model for quality assurance in production, installation and servicing is given under: [GPAT 2020]
(a) ISO 9002
(b) ISO 9000
(c) ISO 9001
(d) ISO 9004
7. As per US FDA, NDA for new chemical entities are classified as either: [GPAT 2019]
(a) ‘P’ for product review or ‘S’ for standard review
(b) ‘P’ for priority review or ‘S’ for standard review
(c) ‘P’ for product review or ‘S’ for safety review
(d) ‘P’ for priority review or ‘S’ for safety review
8. Testing of chemicals by OECD Guideline No. 420 refers to which of the following? [GPAT 2019]
(a) Acute oral toxicity by acute toxic class method
(b) Acute oral toxicity by Up-and-Down procedure
(c) Repeated dose 28-day toxicity study in rodents
(d) Acute oral toxicity by fixed dose procedure
9. Headquarters of Bureau of Indian Standards is situated at: [GPAT 2014]
(a) New Delhi
(b) Mumbai
(c) Kolkata
(d) Chennai
10. Study conditions for long-term stability testing of new drugs is: [GPAT 2013]
(a) 30°C ± 2°C / 65% RH ± 5% RH
(b) 40°C ± 2°C / 65% RH ± 5% RH
(c) 30°C ± 2°C / 75% RH ± 5% RH
(d) 40°C ± 2°C / 75% RH ± 5% RH
ANSWER KEY
| 1-b | 2-d | 3-a | 4-d | 5-b | 6-a | 7-b | 8-d | 9-a | 10-a |
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