1. Which of the following is the primary purpose of sterility testing in the pharmaceutical industry?
a) To detect the presence of microorganisms
b) To assess the effectiveness of sterilization processes
c) To ensure product quality and safety
d) All of the above
Answer: d) All of the above
2. Sterility testing is typically performed on which of the following pharmaceutical products?
a) Oral solid dosage forms
b) Injectable liquids
c) Inhalation products
d) All of the above
Answer: d) All of the above
3. Which of the following methods is commonly used for sterility testing?
a) Membrane filtration
b) Direct inoculation
c) Both a) and b)
d) None of the above
Answer: c) Both a) and b)
4. Which of the following organisms are typically included in sterility test media?
a) Staphylococcus aureus
b) Escherichia coli
c) Candida albicans
d) All of the above
Answer: d) All of the above
5. The incubation period for sterility testing is typically:
a) 24 hours
b) 48 hours
c) 72 hours
d) 7 days
Answer: c) 72 hours
6. The presence of which of the following indicates a positive sterility test?
a) Microbial growth
b) No change in test media
c) Precipitation
d) All of the above
Answer: a) Microbial growth
7. Which of the following factors can influence the outcome of sterility testing?
a) Sterilization method
b) Sample size
c) Test media composition
d) All of the above
Answer: d) All of the above
8. The sterility test method should be validated to ensure:
a) Accuracy
b) Precision
c) Robustness
d) All of the above
Answer: d) All of the above
9. What is the purpose of performing sterility testing on pharmaceutical products after their expiry date?
a) To confirm the product's stability
b) To ensure the continued absence of microorganisms
c) To determine if the product can still be used safely
d) None of the above
Answer: b) To ensure the continued absence of microorganisms
10. In which regulatory guidance document can you find guidelines for sterility testing in the pharmaceutical industry?
a) International Conference on Harmonisation (ICH) guidelines
b) United States Pharmacopeia (USP)
c) European Pharmacopoeia (Ph. Eur.)
d) All of the above
Answer: d) All of the above
11. Which of the following is not a common challenge faced during sterility testing?
a) False positive results
b) False negative results
c) Contamination of test samples
d) Incompatibility between test media and sample matrix
Answer: c) Contamination of test samples
12. Which of the following types of sterilisation processes should be validated before performing sterility testing?
a) Autoclaving
b) Filtration
c) Radiation
d) All of the above
Answer: d) All of the above
13. Which of the following sterilisation processes is generally not suitable for thermolabile pharmaceutical products?
a) Autoclaving
b) Filtration
c) Radiation
d) Dry heat sterilization
Answer: a) Autoclaving
14. Which of the following is not a commonly used container closure system for sterile pharmaceutical products?
a) Glass vials
b) Plastic bottles
c) Aluminum foil wraps
d) Pre-filled syringes
Answer: c) Aluminum foil wraps
15. Which of the following is an example of a rapid sterility testing method?
a) Membrane filtration
b) Direct inoculation
c) Polymerase chain reaction (PCR)
d) None of the above
Answer: c) Polymerase chain reaction (PCR)
16. Which of the following microorganisms is used as a positive control during sterility testing?
a) Bacillus subtilis
b) Pseudomonas aeruginosa
c) Escherichia coli
d) Staphylococcus epidermidis
Answer: a) Bacillus subtilis
17. Which of the following is an advantage of performing sterility testing using membrane filtration?
a) Large sample volumes can be tested
b) It allows for direct inoculation of the test media
c) Results are obtained faster compared to other methods
d) There are no potential false positive results
Answer: a) Large sample volumes can be tested
18. Which of the following is not a critical factor to consider when selecting a test method for sterility testing?
a) Sample size
b) Sensitivity of the method
c) Cost of the method
d) Compatibility with the test product
Answer: c) Cost of the method
19. Which regulatory body oversees the enforcement of sterility testing regulations in the United States?
a) Food and Drug Administration (FDA)
b) European Medicines Agency (EMA)
c) Health Canada
d) World Health Organization (WHO)
Answer: a) Food and Drug Administration (FDA)
20. Which of the following statements about sterility testing is true?
a) It can guarantee 100% sterility assurance
b) It is the final release test for pharmaceutical products
c) It is performed on all batches of pharmaceutical products
d) It is a qualitative test, not a quantitative test
Answer: d) It is a qualitative test, not a quantitative test
21. Which of the following sterilization methods involves the use of high-energy ionizing radiation?
a) Autoclaving
b) Filtration
c) Ethylene oxide sterilization
d) Gamma irradiation
Answer: d) Gamma irradiation
22. Which of the following is an example of a sterility-indicating organism?
a) Escherichia coli
b) Bacillus subtilis
c) Candida albicans
d) Staphylococcus aureus
Answer: b) Bacillus subtilis
23. Which of the following is a common cause of false positive results in sterility testing?
a) Sample contamination during testing
b) Growth of non-viable microorganisms
c) Presence of non-sterile environmental contaminants
d) All of the above
Answer: d) All of the above
24. Which of the following statements about sterility testing is false?
a) It is a requirement for regulatory approval of pharmaceutical products
b) It assesses the fitness for use of a product
c) It ensures the absence of viable microorganisms
d) It is a substitute for routine environmental monitoring
Answer: d) It is a substitute for routine environmental monitoring
25. Which of the following is not a category of sterility testing in the pharmaceutical industry?
a) Initial sterility testing
b) Routine sterility testing
c) Process simulation sterility testing
d) Environmental monitoring sterility testing
Answer: d) Environmental monitoring sterility testing
26. Which of the following is not a commonly used test media for sterility testing?
a) Soybean-casein digest medium
b) Fluid thioglycollate medium
c) Sabouraud dextrose agar
d) MacConkey agar
Answer: d) MacConkey agar
27. Which of the following factors can lead to false negative results in sterility testing?
a) Use of improper incubation conditions
b) Ineffectiveness of the selected test media
c) Insufficient sample size
d) All of the above
Answer: d) All of the above
28. Which of the following best describes the concept of sterility assurance level (SAL)?
a) A measure of the probability of a non-sterile unit in a batch
b) A measure of the microbial load in a product
c) The expected level of non-sterile products in a batch
d) The level of sterility validation required for a product
Answer: a) A measure of the probability of a non-sterile unit in a batch
29. Which of the following is not typically included in the documentation of sterility test results?
a) Test date and duration
b) Incubation temperature and time
c) Sample receiving date
d) Test method used
Answer: c) Sample receiving date
30. Which of the following is a potential consequence of a failed sterility test for a pharmaceutical product?
a) Product recall
b) Regulatory investigation
c) Manufacturing shutdown
d) All of the above
Answer: d) All of the above
ALSO READ: GMP Questions and Answers
.webp)
0 Comments