Questions and Answers on Quality Control (QC)
Questions 1. QC personnel supporting sterile manufacturing activities must have training and experience in:
A. Marketing and finance
B. Microbiology, sterility assurance, and process knowledge
C. Mechanical engineering only
D. Warehouse operations
Answer: B
Questions 2. Specifications for raw materials, components, and products should include limits for:
A. Moisture only
B. Microbial, particulate, and endotoxin/pyrogen contamination
C. Labeling errors
D. Packaging defects
Answer: B
Questions 3. Bioburden testing should be performed on:
A. Every tenth batch
B. Each batch of aseptically filled and terminally sterilized products
C. Only terminally sterilized products
D. Only aseptically filled products
Answer: B
Questions 4. Bioburden limits before final sterilization should be:
A. Arbitrary
B. Based on the efficiency of the sterilization method
C. The same for all products
D. Eliminated for overkill cycles
Answer: B
Questions 5. Samples for bioburden testing should represent:
A. Average-case scenarios
B. Only the first container in a batch
C. Worst-case conditions such as end-of-hold-time
D. Random selections without justification
Answer: C
Questions 6. When overkill sterilization parameters are used, bioburden should be monitored:
A. Never
B. Only once
C. At suitable scheduled intervals
D. Only for the first batch
Answer: C
Questions 7. For parametric release products, bioburden testing should be performed:
A. Once per month
B. For each batch
C. Once per year
D. Only after sterilization
Answer: B
Questions 8. Organisms found during bioburden testing should be:
A. Discarded without concern
B. Identified and assessed for impact on sterilization effectiveness
C. Compared only to historical batches
D. Ignored unless pathogenic
Answer: B
Questions 9. Sterility testing should be considered:
A. The only measure of sterility assurance
B. A replacement for process validation
C. The last in a series of critical control measures
D. Optional for short-shelf-life products
Answer: C
Questions 10. The sterility test must be:
A. Performed in any clean room
B. Conducted under aseptic conditions
C. Done by untrained personnel
D. Performed only on half of the batch
Answer: B
Questions 11. For aseptically filled products, sterility test samples should include containers filled:
A. Only in the middle of the batch
B. Only after interventions
C. At the beginning and end of the batch
D. Only during media fills
Answer: C
Questions 12. For heat-sterilized products, samples should represent:
A. The hottest locations
B. The coolest or slowest-to-heat locations
C. Random samples from storage
D. Only the first load
Answer: B
Questions 13. For lyophilized products, sterility test samples should be taken from:
A. Only one load
B. Different lyophilization loads
C. Only the first vials processed
D. Warmest areas only
Answer: B
Questions 14. Sterility testing for sub-batches should be:
A. Combined
B. Performed only once per day
C. Done separately for each sub-batch
D. Eliminated
Answer: C
Questions 15. When sterility test results cannot be obtained before release, manufacturers must:
A. Skip sterility assurance
B. Release without controls
C. Assess additional monitoring and alternative testing methods
D. Use shorter sterility tests
Answer: C
Questions 16. Decontamination methods for sterility samples (e.g., VHP, UV) must:
A. Completely sterilize the sample
B. Not negatively affect sterility test sensitivity or reliability
C. Replace aseptic technique
D. Remove pyrogens only
Answer: B
Questions 17. Media for product testing must be tested for:
A. Color and clarity only
B. Growth promotion according to pharmacopeia
C. Smell and appearance
D. Sterility only
Answer: B
Questions 18. Environmental monitoring media should include:
A. Only non-pathogenic organisms
B. Designated reference microorganisms and representative local isolates
C. Only Gram-positive isolates
D. Only laboratory-generated strains
Answer: B
Questions 19. Media quality control testing should normally be performed by:
A. The marketing department
B. The end user
C. Only the media manufacturer
D. Outsourced partners always
Answer: B
Questions 20. If relying on supplier or outsourced media testing, manufacturers must:
A. Avoid documentation
B. Justify it and ensure transport/shipping conditions are controlled
C. Assume results are acceptable without verification
D. Only check sterility
Answer: B
Questions 21. Environmental monitoring data for classified areas should be reviewed during:
A. Annual product reviews only
B. Batch certification/release
C. Cleaning validation
D. Media fills only
Answer: B
Questions 22. When environmental data are out of trend, there must be:
A. A verbal discussion
B. Immediate re-sampling only
C. A written procedure outlining actions
D. No change unless limits are exceeded twice
Answer: C
Questions 23. For short-shelf-life products, compliance review may require:
A. Ignoring environmental monitoring
B. Using the most recent available environmental data
C. Re-testing after expiration
D. Eliminating monitoring programs
Answer: B
Questions 24. Rapid or automated microbial methods used in manufacturing must:
A. Be used without validation
B. Only be validated for environmental samples
C. Be validated for the product or process concerned
D. Replace classical microbiological methods
Answer: C
Questions 25. A key purpose of bioburden monitoring before sterilization is to:
A. Eliminate sterility testing
B. Determine worst-case organisms and evaluate sterilization effectiveness
C. Remove endotoxin testing
D. Measure product potency
Answer: B