MCQ of Water for Injection (WFI) July 13, 2023 by Flair Pharma Results HD Quiz powered by harmonic design Table of Contents Toggle Results#1. What is the primary purpose of using WFI in a pharmaceutical plant?#2. Which of the following methods is commonly used for producing WFI?#3. Which of the following impurities should be eliminated from WFI?#4. How is the quality of WFI typically measured?#5. What is the maximum acceptable endotoxin level for WFI?#6. What is the temperature range at which WFI is stored?#7. Which regulatory authority sets the guidelines for WFI production in the pharmaceutical industry?#8. How often should WFI systems be validated?#9. Which of the following statements about WFI is true?#10. What is the purpose of conducting regular microbial monitoring of WFI systems?#11. Which of the following is a potential source of contamination in a WFI system?#12. What is the role of an ultrafiltration and Neno filtration unit in a WFI system?#13. What is the purpose of performing routine testing on WFI samples?#14. What is the Multicolumn process used for in WFI production?#15. Which of the following is an advantage of the Multicolumn process for WFI production?#16. What is the primary disadvantage of the Multicolumn process?#17. Which of the following statements is true regarding the use of sterile water and WFI in pharmaceutical manufacturing? #1. What is the primary purpose of using WFI in a pharmaceutical plant? a) To dilute pharmaceutical products a) To dilute pharmaceutical products b) To clean the manufacturing equipment b) To clean the manufacturing equipment c) To provide drinking water for employees c) To provide drinking water for employees d) To ensure the safety and purity of pharmaceutical products d) To ensure the safety and purity of pharmaceutical products #2. Which of the following methods is commonly used for producing WFI? a) Reverse osmosis a) Reverse osmosis b) Distillation b) Distillation c) Filtration c) Filtration d) All of the above d) All of the above #3. Which of the following impurities should be eliminated from WFI? a) Microorganisms a) Microorganisms b) Heavy metals b) Heavy metals c) Dissolved gases c) Dissolved gases d) All of the above d) All of the above #4. How is the quality of WFI typically measured? a) pH level a) pH level b) Conductivity b) Conductivity c) TOC c) TOC d) All of the above d) All of the above #5. What is the maximum acceptable endotoxin level for WFI? a) 100 EU/mL a) 100 EU/mL b) 1000 EU/mL b) 1000 EU/mL c) 10 EU/mL c) 10 EU/mL d) 20 EU/mL d) 20 EU/mL #6. What is the temperature range at which WFI is stored? a) 40-55°C a) 40-55°C b) 60-75°C b) 60-75°C c) 30-35°C c) 30-35°C d) 70-90°C d) 70-90°C #7. Which regulatory authority sets the guidelines for WFI production in the pharmaceutical industry? a) FDA (Food and Drug Administration) a) FDA (Food and Drug Administration) b) WHO (World Health Organization) b) WHO (World Health Organization) c) EMA (European Medicines Agency) c) EMA (European Medicines Agency) d) All of the above d) All of the above #8. How often should WFI systems be validated? a) Once a year a) Once a year b) Once every three years b) Once every three years c) Once every five years c) Once every five years d) Whenever significant changes occur d) Whenever significant changes occur #9. Which of the following statements about WFI is true? a) It is not required for the production of injectable product a) It is not required for the production of injectable product b) It contains minerals and salts. b) It contains minerals and salts. c) It is produced from tap water without any purification. c) It is produced from tap water without any purification. d) It is sterile and pyrogen-free. d) It is sterile and pyrogen-free. #10. What is the purpose of conducting regular microbial monitoring of WFI systems? a) To measure the conductivity of the water a) To measure the conductivity of the water b) To ensure the absence of endotoxins b) To ensure the absence of endotoxins c) To detect the presence of microorganisms in the water c) To detect the presence of microorganisms in the water d) To determine the pH level of the water d) To determine the pH level of the water #11. Which of the following is a potential source of contamination in a WFI system? a) Particulate matter in the air a) Particulate matter in the air b) Improperly cleaned storage tanks b) Improperly cleaned storage tanks c) Inadequate sanitization procedures c) Inadequate sanitization procedures d) All of the above d) All of the above #12. What is the role of an ultrafiltration and Neno filtration unit in a WFI system? a) To remove dissolved gases a) To remove dissolved gases b) To remove endotoxins and bacteria b) To remove endotoxins and bacteria c) To adjust the pH level c) To adjust the pH level d) To add minerals and salts d) To add minerals and salts #13. What is the purpose of performing routine testing on WFI samples? a) To ensure compliance with regulatory standards a) To ensure compliance with regulatory standards b) To evaluate the taste and odor of the water b) To evaluate the taste and odor of the water c) To determine the turbidity of the water c) To determine the turbidity of the water d) To assess the color of the water d) To assess the color of the water #14. What is the Multicolumn process used for in WFI production? a) Removal of endotoxins a) Removal of endotoxins b) Removal of Micro-organism b) Removal of Micro-organism c) Removal of dissolved gases c) Removal of dissolved gases d) All of the above d) All of the above #15. Which of the following is an advantage of the Multicolumn process for WFI production? a) Lower operational cost compared to other methods a) Lower operational cost compared to other methods b) Simpler process with fewer steps b) Simpler process with fewer steps c) Higher water recovery rate c) Higher water recovery rate d) All of the above d) All of the above #16. What is the primary disadvantage of the Multicolumn process? a) Higher initial investment cost a) Higher initial investment cost b) Increased risk of cross-contamination b) Increased risk of cross-contamination c) Lower water quality compared to other methods c) Lower water quality compared to other methods d) All of the above d) All of the above #17. Which of the following statements is true regarding the use of sterile water and WFI in pharmaceutical manufacturing? a) Sterile water is used exclusively for cleaning purposes. a) Sterile water is used exclusively for cleaning purposes. b) WFI is only used for the preparation of oral medications. b) WFI is only used for the preparation of oral medications. c) Sterile water and WFI are both critical components in ensuring product safety and quality. c) Sterile water and WFI are both critical components in ensuring product safety and quality. d) Sterile water and WFI can be used interchangeably without any impact on product quality. d) Sterile water and WFI can be used interchangeably without any impact on product quality. Finish
