Questions & Answers on Pharma Equipment EUGMP- Annex-1
Questions 1. According to section 5.1, what should be available as part of the initial qualification package?
A. Equipment purchase invoices
B. A written, detailed description of the equipment design
C. Cleaning and disinfection SOPs
D. Environmental monitoring trend reports
Answer: B
Questions 2. What should be defined in the “user requirements specifications” during early development?
A. Personnel qualifications
B. Equipment monitoring requirements
C. Final product specifications
D. Calibration schedules
Answer: B
Questions 3. How should critical alarms be reviewed according to section 5.2?
A. Monthly
B. Quarterly
C. Immediately
D. Whenever equipment is serviced
Answer: C
Questions 4. What is the preferred design approach for equipment and services related to cleanrooms?
A. Install all equipment inside the cleanroom
B. Allow operations and maintenance to be done outside the cleanroom as much as possible
C. Allow only repairs outside but operations inside
D. Restrict equipment access to operators only
Answer: B
Questions 5. If maintenance must be performed inside the cleanroom and cleanliness cannot be maintained, what should be considered?
A. Reducing environmental monitoring frequency
B. Removing all equipment
C. Restricting access, defined procedures, and additional cleaning/disinfection
D. Discontinuing production for the day
Answer: C
Questions 6. When should sterilisation of equipment be carried out (if required)?
A. Before disassembly
B. After complete reassembly
C. During maintenance
D. Before installation
Answer: B
Questions 7. What is the purpose of cleaning validation?
A. To ensure equipment is easy to operate
B. To reduce downtime
C. To remove residues and minimize contamination before disinfection
D. To improve equipment lifespan
Answer: C
Questions 8. Which of the following are considered direct product contact parts?
A. Stopper bowls
B. Filling needles and pumps
C. Transfer hatches
D. Cleanroom walls
Answer: B
Questions 9. Indirect product contact parts include equipment parts that:
A. Directly touch the product
B. Do not contact the product but may touch other sterilised surfaces
C. Are never sterilised
D. Only require routine cleaning
Answer: B
Questions 10. Which of the following equipment must be subject to qualification, monitoring, and planned maintenance?
A. Office HVAC
B. Packaging machines
C. Sterilisers, air handling systems, and water systems
D. Computer equipment
Answer: C
Questions 11. After maintenance on critical equipment is completed, what must happen before it is used again?
A. It must be calibrated
B. It must be approved for return to use
C. It must undergo operator training
D. It must be documented by production only
Answer: B
Questions 12. What must be performed and recorded before unplanned maintenance of equipment critical to sterility?
A. Cleaning validation
B. Environmental monitoring
C. Impact assessment on sterility
D. Personnel qualification review
Answer: C
Questions 13. When can a conveyor belt pass through a partition between a Grade A/B area and a lower-grade area?
A. When personnel are supervising
B. When the belt is continually sterilised
C. When the belt speed is reduced
D. When pressure differentials are equal
Answer: B
Questions 14. Particle counters and sample tubing must be:
A. Lightweight and portable
B. Qualified
C. Sterilised daily
D. Used only in Grade A areas
Answer: B
Questions 15. What is the typical recommended maximum length for particle counter sampling tubing unless justified?
A. 50 cm
B. 2 meters
C. 1 meter
D. 3 meters
Answer: C
Questions 16. For classification purposes, what type of particle counter should be used?
A. Fixed particle counters
B. Portable particle counters with a short sample tube
C. Manual particle counters
D. Remote automated counters only
Answer: B
Questions 17. What type of sampling head should be used in unidirectional airflow systems?
A. Static sampling heads
B. Random airflow sampling heads
C. Isokinetic sampling heads
D. Mechanical extraction sampling heads
Answer: C
Questions 18. Where should isokinetic sampling heads be positioned?
A. As far as possible from critical areas
B. At operator workstations
C. Close to the critical location to ensure representative samples
D. Near the air return grilles
Answer: C