Standard Institutions & Regulatory Authorities | Pharmaceutical Management | GPAT Mock Test

Welcome to this focused mock test on Standard Institutions and Regulatory Authorities, a critical topic for the GPAT examination. This quiz is designed to test your understanding of key global and national bodies that shape the pharmaceutical landscape. You will face questions on the roles, functions, and importance of organizations like CDSCO, USFDA, WHO, ICH, ISO, and BIS. A strong grasp of these authorities is essential for a career in the pharmaceutical industry. This test consists of 25 multiple-choice questions to sharpen your knowledge and boost your preparation. After submitting your answers, you can review your score and download all questions with the correct answers in PDF format for future revision. Good luck!

1. The Central Drugs Standard Control Organization (CDSCO) in India is headed by the:

2. Which ICH guideline series deals with ‘Quality’ aspects of pharmaceuticals?

3. The headquarters of the World Health Organization (WHO) is located in:

4. The USFDA issues a ‘Form 483’ at the conclusion of an inspection to notify a company of:

5. Which ISO standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements?

6. The ‘ISI mark’ is a certification mark for industrial products in India, provided by which organization?

7. What is the primary mission of the International Council for Harmonisation (ICH)?

8. In the USFDA, which center is primarily responsible for the regulation of biologic products?

9. The WHO’s “Prequalification of Medicines Programme” ensures that medicines supplied by procurement agencies for diseases like HIV/AIDS, malaria, and tuberculosis meet acceptable standards of:

10. In India, the approval for conducting new clinical trials is granted by:

11. An Abbreviated New Drug Application (ANDA) is submitted to the USFDA for the approval of a:

12. The ICH was founded by the regulatory authorities and pharmaceutical industry associations of which three regions?

13. The Bureau of Indian Standards (BIS) is the National Standard Body of India established under the:

14. What is the primary purpose of the WHO Model List of Essential Medicines?

15. The ‘Orange Book’ published by the USFDA contains a list of:

16. The zonal and sub-zonal offices of CDSCO are responsible for:

17. Which ICH guideline addresses the topic of Good Clinical Practice (GCP)?

18. ISO is a non-governmental organization that develops and publishes international standards. What does ‘ISO’ stand for?

19. Which of the following is a primary function of the USFDA?

20. The WHO Good Manufacturing Practices (GMP) are an essential part of:

21. The Common Technical Document (CTD), an ICH initiative, is a format for:

22. The pharmacovigilance program in India is coordinated by the National Coordination Centre (NCC) under the aegis of:

23. ISO 9001 is a widely recognized standard for:

24. What is the main objective of the International Pharmacopoeia, published by WHO?

25. Which authority in India is responsible for regulating medical devices?

Author

  • G S Sachin
    : Author

    G S Sachin is a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. He holds a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research and creates clear, accurate educational content on pharmacology, drug mechanisms of action, pharmacist learning, and GPAT exam preparation.

    Mail- Sachin@pharmacyfreak.com

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