Audit of sterile production and packaging MCQs With Answer

Introduction: This quiz collection on Audit of Sterile Production and Packaging is designed for M.Pharm students preparing for advanced coursework and regulatory examinations. It focuses on key audit topics such as cleanroom classification, environmental monitoring, aseptic processing, media fills, sterilization validation, container-closure integrity, HVAC and HEPA systems, isolators/RABS, contamination control strategy, and regulatory expectations (e.g., EU GMP Annex 1, PIC/S, FDA). Questions emphasize practical audit observations, root-cause analysis, corrective actions, and documentation expectations to build competence in evaluating sterile manufacturing and packaging operations. Use these MCQs to assess knowledge and prepare for real-world audit scenarios in sterile production.

Q1. Which environmental classification corresponds to the critical zone where aseptic assembly of sterile product containers typically occurs according to EU GMP Annex 1?

• Grade D
• Grade C
• Grade B
• Grade A

Correct Answer: Grade A

Q2. During an aseptic process audit, which of the following is the most appropriate indicator that a media-fill challenge is representative of routine operations?

• Use of a simplified gowning procedure to reduce variability
• Conducting media fills only during off-shift when operators are less stressed
• Using the same equipment, materials, personnel, and environmental conditions as in routine production
• Replacing routine personnel with experienced auditors to minimize contamination

Correct Answer: Using the same equipment, materials, personnel, and environmental conditions as in routine production

Q3. Which monitoring method is most effective for routine detection of viable airborne contamination in a Grade A critical zone?

• Contact plate sampling of operator gloves
• Active air sampling with a volumetric air sampler
• Particle counting with a light-scattering particle counter
• Surface swab sampling of work surfaces

Correct Answer: Active air sampling with a volumetric air sampler

Q4. In a sterile packaging audit, which container closure integrity (CCI) test provides a non-destructive and highly sensitive method suitable for routine release testing of parenteral products?

• Dye ingress test
• Bubble emission (submersion) test
• Vacuum decay test
• Visual leak inspection

Correct Answer: Vacuum decay test

Q5. Which HVAC parameter is most critical to maintain to prevent inward contamination into a sterile processing area?

• Supply air temperature
• Relative humidity in the building perimeter
• Positive differential pressure relative to adjacent less-clean areas
• Frequency of HVAC filter replacement irrespective of differential

Correct Answer: Positive differential pressure relative to adjacent less-clean areas

Q6. During an audit, you find recurring growth of Gram-negative bacilli in environmental samples of a sterile fill suite. Which corrective action should be prioritized?

• Increase sampling frequency without changing controls
• Replace all HEPA filters immediately without investigation
• Perform root cause analysis focusing on water systems, sinks, condensate, and HVAC leaks and implement targeted remediation
• Ignore environmental isolates if product sterility tests remain compliant

Correct Answer: Perform root cause analysis focusing on water systems, sinks, condensate, and HVAC leaks and implement targeted remediation

Q7. Which documentation item must be available and reviewed by an auditor to verify sterility assurance of terminally sterilized products?

• Media fill reports for aseptic processing
• Sterilization cycle development and validation data including biological indicator results
• Operator training records for packaging line only
• Daily production output logs without sterilization records

Correct Answer: Sterilization cycle development and validation data including biological indicator results

Q8. What is the primary objective of a process simulation (media fill) for aseptic manufacturing?

• To validate the sterilization process parameters
• To qualify HVAC systems for particle counts
• To simulate routine operations and evaluate the aseptic process for potential sources of contamination
• To test packaging material compatibility with drug substances

Correct Answer: To simulate routine operations and evaluate the aseptic process for potential sources of contamination

Q9. When auditing isolator-based aseptic lines, which attribute most strongly indicates adequate operator protection of the sterile zone?

• Operators wearing double gloves outside the isolator
• Frequent opening of glove ports to pass components quickly
• Validated glove integrity checks and controlled procedures for glove change and intervention
• Use of open-lid workstations within the isolator

Correct Answer: Validated glove integrity checks and controlled procedures for glove change and intervention

Q10. Which particle count trend during cleanroom certification would be most concerning to an auditor for a Grade B area supporting aseptic operations?

• Stable counts well below limits over several measurements
• A sudden step increase in >0.5 µm particle counts during a certification run
• Slight diurnal fluctuation within expected limits
• Transient spikes during door openings that return to baseline quickly

Correct Answer: A sudden step increase in >0.5 µm particle counts during a certification run

Q11. Which regulatory document specifically provides current detailed expectations for sterile product manufacture in the EU and is a key reference for audits?

• ICH Q7
• FDA 21 CFR Part 211
• EU GMP Annex 1
• PIC/S GMP Chapter 5 only

Correct Answer: EU GMP Annex 1

Q12. In packaging audits, which test best evaluates seal integrity of flexible sterile pouches intended for terminal sterilization?

• Tensile strength test of package material
• Seal peel test under dry conditions only
• Whole-package integrity test such as helium leak or vacuum decay
• Visual inspection of printed lot code

Correct Answer: Whole-package integrity test such as helium leak or vacuum decay

Q13. What is the most appropriate sampling location strategy for surface microbiological monitoring in a Grade A work zone?

• Sampling only floor areas where traffic is highest
• Targeting critical touch points such as gloves, transfer areas, and product contact surfaces
• Sampling outside the cleanroom only to save resources
• Relying solely on particle counts without surface sampling

Correct Answer: Targeting critical touch points such as gloves, transfer areas, and product contact surfaces

Q14. During an audit you observe that the routine cleaning agent for the aseptic suite has changed but no risk assessment or change control was documented. This is a finding against which GMP expectation?

• Inadequate personnel training records
• Poor batch record completion
• Failure to follow change control and risk assessment procedures
• Lack of environmental monitoring program

Correct Answer: Failure to follow change control and risk assessment procedures

Q15. Which of the following is the best indicator during an audit that a sterile production facility has a robust contamination control strategy?

• High frequency of non-critical deviations logged
• Documented contamination control strategy with qualified controls, monitoring, trend analysis, and timely CAPAs
• Minimal employee training records but low environmental isolates
• Reliance on terminal sterilization alone without environmental controls

Correct Answer: Documented contamination control strategy with qualified controls, monitoring, trend analysis, and timely CAPAs

Q16. For audit sampling, what is the primary reason to include settle plates near the filling line even if active air sampling is performed?

• Settle plates quantify non-viable particulates
• They provide a time-integrated measure of viable fallout onto surfaces
• They replace the need for glove fingertip sampling
• They are cheaper and thus preferable over any active sampling

Correct Answer: They provide a time-integrated measure of viable fallout onto surfaces

Q17. Which microbiological alert or action level concept used in environmental monitoring indicates the need for immediate investigation and possible corrective action?

• Seasonal trend limit
• Action limit
• Background fluctuation threshold
• Historical mean

Correct Answer: Action limit

Q18. During an audit of sterilization processes, which indicator provides the most direct evidence that a moist heat sterilization cycle achieved required lethality?

• Mechanical cycle printout showing temperature and time
• Use of chemical indicator strips in each load
• Biological indicator demonstrating inactivation of a defined microbial population
• End-product sterility test for each batch

Correct Answer: Biological indicator demonstrating inactivation of a defined microbial population

Q19. What audit observation would most strongly suggest that operator aseptic technique is contributing to contamination risk?

• Operators follow a standard glove disinfection procedure before entry
• Frequent contact between gloved hands and non-sterile surfaces inside the critical zone
• Consistent use of single-use sterile consumables
• Operators change gloves as scheduled and after known contamination events

Correct Answer: Frequent contact between gloved hands and non-sterile surfaces inside the critical zone

Q20. Which metric is most appropriate for an auditor to review when assessing long-term control of aseptic operations?

• Single-day particle counts only
• Trend analysis of environmental monitoring data, media fill results, deviation rates, and CAPA effectiveness over time
• Batch output per shift only
• Supplier invoices for consumables

Correct Answer: Trend analysis of environmental monitoring data, media fill results, deviation rates, and CAPA effectiveness over time

Download