FINAL YEAR UNIVERSITY EXAMINATION 2019-2020  
                  Final Year B. Pharm. Semester VIII 
             Subject: Pharmaceutical Regulatory Affairs (BPH_E_809_T) 
                    PRACTICE QUESTION BANK 
                            
        1.  Select the responsibility/s of RA personnel  
           a.  To analyze the content of the active ingredient in the formulation  
           b.  Work with federal, state and local governing agencies to get the approval for drug  
           c.  To undertake stability studies of the drug products  
           d.  To supervise the production of the formulation 
        2.  How many drugs can be imported under single Form11 license?  
           a.  20 
           b.  5 
           c.  10 
           d.  15 
        3.  List of approved drugs and their associated IPR is available in ________ 
           a.  Pink book  
           b.  Orange book  
           c.  Red book  
           d.  Black book 
        4.  Identify the relevant regulatory body in USFDA for approval of drugs.  
           a.  BLA  
           b.  IND  
           c.  CBER  
           d.  CDER 
        5.  In US the Orphan Drug Exclusivity (ODE) last for ……years 
           a.  5 
           b.  6 
           c.  7 
           d.  8 
        6.  In Europe, variations are classified as Type-IA for ….........change  
           a.  Minor  
           b.  Major 
           c.  Moderate  
           d.  Relative 
        7.  …….. are the committees related to EU Regulations  
           a.  TGA 
           b.  CDER 
           c.  CBER  
           d.  COMP 
        8.  The “Certificate of Suitability” as per EU guidelines is valid for…... years from the date 
          when the original certificate was granted. 
           a.  5 
           b.  10 
           c.  15 
           d.  20 
        9.  CTD is divided into …..modules 
           a.  3 
           b.  4 
           c.  5 
           d.  6 
        10. Schedule ….....of the D&C Act 1940 and Rules 1945 deals with the guidelines for Good 
          Manufacturing Practices 
           a.  Y 
           b.  M 
           c.  P 
           d.  X 
        11. The entry in Batch Manufacturing Record is done by 
           a.  Quality control department 
           b.  Quality assurance department 
           c.  Warehouse department 
           d.  Production department 
        12. In pharmacovigilance the term ADR stands for _________ 
           a.  Adverse Drug Reaction 
           b.  Adverse Dose Reaction 
           c.  Absolute Drug Reaction 
           d.  Absolute Dose Reaction 
        13. BCS classification for Class III drugs is 
           a.  High solubility high permeability  
           b.  Low solubility high permeability  
           c.  High solubility low permeability  
           d.  Low solubility Low permeability  
        14. As per ANDA requirements the bioequivalence of test to reference formulation is 
          _________ 
           a.  80-120% 
           b.  100-150% 
           c.  70-130% 
           d.  70-80% 
        15. Which of the following is regulatory authority of Australia 
           a.  Pharmaceutical and Medical Devices Agency  
           b.  Therapeutic Goods Administration 
           c.  Medicines and Healthcare Products Regulatory Agency  
           d.  Central Drug Standard Control Organization  
        16. Which of the following is an International regulatory authority for drug regulation 
           a.  CDSCO 
           b.  US-FDA 
           c.  WHO 
           d.  EMA 
        17. The oldest quality control laboratory of the Drug Control Authorities in India is 
           a.  Central Drugs Testing Laboratory, Kolkata  
           b.  Central Drugs Testing Laboratory (CDTL) Chennai , Tamil Nadu  
           c.  Central Drugs Testing Laboratory (CDTL) Hyderabad, AP  
           d.  Central Drugs Testing Laboratory (CDTL), Mumbai 
        18. Which of the following is a branch of CDL- 
           a.  New Delhi 
           b.  Kolkata 
           c.  Faridabad 
           d.  Bangalore 
        19. Indian Pharmacopoeia Commission headquarter is located at  
           a.  Delhi 
           b.  Mumbai 
           c.  Hyderabad 
           d.  Ghaziabad  
        20. Central drug Testing Laboratory is located at _____________ 
           a.  Kasauli 
           b.  Delhi  
           c.  Bangalore 
           d.  Lucknow 
        21. The 1st edition of Indian Pharmacopoeia was published in the year 
           a.  1966 
           b.  1955 
           c.  1950 
           d.  1960 
        22. The objective of FDA- India office is-  
           a.  To  ensure  the  safety,  quality,  and  effectiveness  of  medical  products  and  food 
             produced in India for export to the United States. 
           b.  Approval of medical products for marketing in India 
           c.  Import of drug in India for test and examination  
           d.  Manufacture of drugs in USA for the purpose of export to India 
        23. The chairman of Indian Pharmacopoeial commission is- 
           a.  Chairman-Scientific Body 
           b.  The Drugs Controller General 
           c.  Directorate General of Health Services 
           d.  The Secretary, Ministry of Health and Family Welfare 
        24. In PCT, patent application enters national phase at- 
           a.  12 months 
           b.  24 months 
           c.  30 months 
           d.  36 months  
        25. The term of patent is valid for the period of 20 years from the