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Pharmaceutical Regulatory Affairs (BPH E 809 T) PRACTICE QUESTION BANK 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 a. Date of approval b. Date of examination c. Date of publication d. Date of filing of application 26. Copyrights is granted for- a. Pharmaceutical product b. Logo c. Music and Literature d. Radio isotopes 27. The guidelines for good manufacturing practice in India is- a. 21 CFR Part 4 b. Schedule M c. 21 CFR Part 211 d. Eudralex Volume 4 28. Which of the following is a part of 4 M’s of quality manufacturing- a. Machine b. Mechanism c. Manufacturing d. Modelling 29. The guideline ICH Q1A (R2) refers to a. Stability study of new molecular entities and associated drug products. b. Generation of photostability information c. Analytical validation d. Impurities 30. Impurity for which a structural characterization has not been achieved and that is solely defined by qualitative analytical properties is known as- a. Specified impurity b. Unidentified impurity c. Unspecified impurity d. Identified impurity 31. As per ICH guidelines Chloroform is classified as- a. Class I solvent b. Class II solvent c. Class III d. Class IV 32. Quality by design (QbD) is a concept introduced by the international conference on harmonization (ICH) as ____________guideline a. ICH Q5 b. ICH Q6 c. ICH Q7 d. ICH Q8 33. Prior to 2004, EMA was known as a. European Agency for the Evaluation of Medicinal Products b. European Medicines External Agency c. European Medicine Examination and Assessment d. European Medicine Examination Agency 34. Marketing Authorization Application (MAA) is an application to the relevant authority to market a drug or medicine in a. US market b. Europe market c. Canadian market d. All countries 35. If any organization wishes to market their product only in one EU country then_______ is preferred procedure. a. National Procedures b. Mutual recognition Procedure c. Centralized Procedure d. decentralized Procedure 36. Drug regulatory body of Brazil is a. TGA b. SFDA c. MHLW d. ANVISA 37. ASMF stands for- a. Active substance master file b. Assessment of substance master file c. Active substance master formula d. Assessment of substance main formula 38. Variations that are the minor variations which have only a minimal impact or no impact at all, on the quality, safety or efficacy of the medicinal product are called as a. Type IA variation b. Type IB variation c. Type II variation d. Extension applications 39. As per EU guidelines post approval changes including replacement of a chemical active substance by a different salt/ester complex/derivative with the same therapeutic moiety, where the efficacy/safety characteristics are not significantly different is known as- a. Type IA variation b. Type IB variation c. Type II variation d. Extension applications 40. Variation approval timeline for II type of variation as per EU guideline is a. 30- 90 days b. 150- 180 days c. 210 days d. 120 days 41. Name the type of NDA application that needs to be filed in united states for combination of two or more active moieties a. Type 2 b. Type 4 c. Type 5 d. Type 6 42. cGMP regulations for pharmaceutical manufacturing comes under which organization domain of US FDA a. Center for Biologics Evaluation and Research b. Center for Food Safety and Applied Nutrition c. Office of Regulatory Affairs (ORA) d. Center for Drug Evaluation and Research (CDER) 43. _______ product does not require a BLA a. Serum b. Glucagon c. Blood, blood component or derivative d. Vaccine 44. A competitor can file for ANDA before its expiry under _______ clause of ANDA certification clause a. Para I b. Para II c. Para III d. Para IV 45. Animal studies, clinical trials, bioavailability studies are part of which application process a. IND b. NDA c. ANDA d. BLA 46. Under GAIN Title VIII of the FDA Safety and Innovation Act, FDA can grant an additional ________ years to certain exclusivity periods for products that have been granted a Qualified Infectious Disease Product (QIDP) designation a. 6 months b. 4 years c. 5 years d. 7 years 47. Type I DMF deals with a. Packaging materials b. Manufacturing Site c. Drug substance d. Excipients 48. CFR stands for a. Code of Federal Regulations b. Centre of Federal Regulations c. Code of Federal Register d. Centre of Federal Regulator 49. The headquarter of the WTO is located at __________ a. Geneva b. Belgium c. Austria d. Czech 50. The initiation of ICH took place with representatives of regulatory agencies of................ to discuss the wider implications and terms of reference. a. Japan,Australia, US b. US, Europe, India c. US, Europe, Japan d. Europe ,Australia, US FINAL YEAR UNIVERSITY EXAMINATION 2019-2020 Final Year B. Pharm. Semester VIII Pharmaceutical Regulatory Affairs (BPH_E_809_T) PRACTICE QUESTION BANK ANSWER KEYS 1. (b) 2. (c) 3. (b) 4. (d) 5. (c) 6. (a) 7. (d) 8. (a) 9. (c) 10. (b) 11. (d) 12. (a) 13. (c) 14. (a) 15. (b) 16. (c) 17. (a) 18. (b) 19. (d) 20. (a) 21. (b) 22. (a) 23. (d) 24. (c) 25. (d) 26. (c) 27. (b) 28. (a) 29. (a) 30. (b) 31. (b) 32. (d) 33. (a) 34. (b) 35. (a) 36. (d) 37. (a) 38. (a) 39. (d) 40. (a) 41. (b) 42. (d) 43. (b) 44. (c) 45. (b) 46. (c) 47. (b) 48. (a) 49. (a) 50. (d) Final Year B. Pharm CBCS (Semester VIII) Pharmaceutics IV Theory Examination ACADEMIC YEAR 2019-2020 MOCK QUESTIONS Cluster 1 1. Sealed glass containers with an elongated neck a. Gauge b. Ampules c. CSP d. Vial 2. A high efficiency air filter a. HEPA filter b. Diluent c. Final filter d. Web filter 3. A solvent that dissolves a lyophilized powder or dilutes a solution a.
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