Questions & Answers Disinfection in Pharma EUGMP- Annex-1
Questions 1. According to section 4.33, what is required before disinfection can be effective?
A. Temperature control
B. Prior cleaning to remove surface contamination
C. Use of a sporicidal agent
D. Personnel training
Answer: B
Questions 2. Cleanrooms should be cleaned and disinfected:
A. Only during shutdown periods
B. Once a month
C. Thoroughly according to a written programme
D. Only when contamination is detected
Answer: C
Questions 3. Why should more than one type of disinfecting agent be used?
A. To reduce cost
B. To avoid equipment damage
C. To ensure effectiveness through different modes of action
D. To reduce residue formation
Answer: C
Questions 4. Disinfection programmes should periodically include the use of:
A. Sterile water
B. HEPA-filtered air
C. A sporicidal agent
D. Detergents only
Answer: C
Questions 5. Monitoring of the disinfection programme should be performed regularly to:
A. Reduce labour cost
B. Detect changes in microbial flora and assess effectiveness
C. Confirm temperature of the cleanroom
D. Replace cleaning staff
Answer: B
Questions 6. What must the validation studies of the disinfection process demonstrate?
A. That cleaning staff are trained
B. Suitability and effectiveness of disinfectants on specific surfaces
C. That disinfectants are inexpensive
D. That surfaces are smooth
Answer: B
Questions 7. Validation must support which of the following regarding disinfectant solutions?
A. Their colour stability
B. The in-use expiry periods of prepared solutions
C. The manufacturer’s brand claim
D. The viscosity of the solution
Answer: B
Questions 8. Disinfectants and detergents used in Grade A and B areas must be:
A. Diluted before use
B. Free from residues
C. Sterile prior to use
D. Scented
Answer: C
Questions 9. In Grade C and D areas, disinfectants may be required to be sterile when:
A. Operators request it
B. Determined in the CCS (Contamination Control Strategy)
C. There is an audit
D. Surfaces are metallic
Answer: B
Questions 10. When disinfectants or detergents are diluted by the manufacturer, the preparation should be done:
A. In open containers
B. In a manner preventing contamination
C. Only during day shifts
D. Without monitoring
Answer: B
Questions 11. Diluted disinfectants should be kept in containers that are:
A. Brand new
B. Plastic only
C. Previously cleaned and sterilized where applicable
D. Transparent
Answer: C
Questions 12. How long should diluted disinfectants be stored?
A. Indefinitely
B. Until discolouration occurs
C. Only for the defined period
D. For at least one week
Answer: C
Questions 13. If disinfectants are supplied “ready-made,” which documentation can be accepted?
A. Purchase invoices
B. Certificates of analysis or conformance
C. Operator training records
D. Batch manufacturing records
Answer: B
Questions 14. Acceptance of certificates for ready-made disinfectants depends on:
A. Vendor qualification being successfully completed
B. The colour of the solution
C. The cost of the product
D. Whether the disinfectant has a strong odour
Answer: A
Questions 15. When fumigation or vapour disinfection (e.g., Vapour-phase Hydrogen Peroxide) is used, what must be validated?
A. The quantity of air changes
B. Effectiveness of the fumigation agent and dispersion system
C. Staff attendance
D. Temperature uniformity in the cleanroom
Answer: B