Cleaning validation of facilities MCQs With Answer

This blog provides a focused question bank on cleaning validation of facilities tailored for M.Pharm students preparing for exams and practicals. Cleaning validation ensures that equipment, surfaces, and utilities are free from unacceptable residues, cross-contamination, and microbial contamination after cleaning. Topics covered in these MCQs include regulatory expectations, worst-case product selection, residue limit calculations, sampling techniques (swab and rinse), analytical methods (TOC, HPLC), recovery studies, specificity, LOD/LOQ, and documentation requirements. Each question is designed to probe conceptual understanding and application in real-world scenarios, helping you strengthen problem-solving skills and recall critical criteria needed for robust cleaning validation programs.

Q1. Which of the following best describes the primary objective of cleaning validation in pharmaceutical facilities?

• To reduce the cleaning time between production batches
• To confirm the cleaning procedure reliably removes residues to acceptable levels
• To demonstrate cost savings from less frequent cleaning
• To validate the microbiological sterility of final products

Correct Answer: To confirm the cleaning procedure reliably removes residues to acceptable levels

Q2. When selecting a worst-case product for cleaning validation, which characteristic is most important?

• Highest therapeutic potency regardless of solubility
• Lowest production batch size
• Highest risk for carryover due to low solubility and high potency
• Most frequently manufactured product irrespective of properties

Correct Answer: Highest risk for carryover due to low solubility and high potency

Q3. Which sampling method is most appropriate for validating residue removal from a defined surface area on equipment?

• Air impaction sampling
• Swab sampling with defined surface area
• Bulk product sampling
• Environmental settle plates

Correct Answer: Swab sampling with defined surface area

Q4. In cleaning validation, TOC is commonly used to detect what type of residue?

• Only ionic residues
• Total organic carbon representing organic residues
• Specific active pharmaceutical ingredient identity
• Viable microbial contaminants only

Correct Answer: Total organic carbon representing organic residues

Q5. The Acceptable Daily Exposure (ADE) approach is used to establish which cleaning validation parameter?

• Sampling technique for swab recovery
• Cleaning agent concentration
• Permitted carryover limit (acceptance criteria) based on safety
• Microbial action limit for environmental monitoring

Correct Answer: Permitted carryover limit (acceptance criteria) based on safety

Q6. What is the purpose of a swab recovery study in cleaning validation?

• To validate the final product assay method
• To determine the percentage of residue recovered by the swab method
• To estimate microbial reduction achieved by cleaning
• To evaluate operator cleaning techniques only

Correct Answer: To determine the percentage of residue recovered by the swab method

Q7. Which analytical parameter indicates the smallest concentration that can be distinguished from background noise in a cleaning validation assay?

• Limit of Quantitation (LOQ)
• Limit of Detection (LOD)
• Linearity range
• Specificity

Correct Answer: Limit of Detection (LOD)

Q8. When calculating an acceptance limit using the 10 ppm criterion, what does 10 ppm refer to?

• 10 parts of cleaning agent per million parts of air
• 10 milligrams of contaminant per liter of rinse solution
• 10 parts of product per million parts of next product by weight on equipment surfaces
• 10 percent of the allowable daily exposure

Correct Answer: 10 parts of product per million parts of next product by weight on equipment surfaces

Q9. Which stage of cleaning validation is performed after validation parameters are established and during routine manufacturing to confirm ongoing control?

• Prospective validation
• Retrospective validation
• Concurrent validation
• Analytical method validation

Correct Answer: Concurrent validation

Q10. Specificity in an analytical method for cleaning validation means:

• Method can quantify analyte only when present in very large amounts
• Method can measure the analyte in presence of matrix, cleaning agents and degradation products without interference
• Method has a very low limit of detection
• Method recovery is greater than 100%

Correct Answer: Method can measure the analyte in presence of matrix, cleaning agents and degradation products without interference

Q11. Which of the following is a regulatory expectation for cleaning validation documentation?

• Only verbal approval from the production manager is required
• Comprehensive records including protocols, reports, approvals, and deviations must be maintained
• No documentation is required for routine cleaning
• Documentation limited to final product sterility certificates

Correct Answer: Comprehensive records including protocols, reports, approvals, and deviations must be maintained

Q12. Which is an advantage of using rinse sampling compared to swab sampling?

• Rinse sampling provides better spatial resolution of small crevices
• Rinse sampling can sample complex internal geometries and larger surface areas
• Rinse sampling does not require analytical method validation
• Rinse sampling eliminates the need for cleaning procedures

Correct Answer: Rinse sampling can sample complex internal geometries and larger surface areas

Q13. During cleaning validation, why is it important to include the cleaning agent and its degradation products in method specificity evaluation?

• Because cleaning agents always enhance analyte signal
• To ensure they do not interfere with analyte detection and cause false positives or negatives
• Because regulatory agencies require only cleaning agent testing
• It reduces the need for swab recovery studies

Correct Answer: To ensure they do not interfere with analyte detection and cause false positives or negatives

Q14. What does the term “carryover” mean in the context of cleaning validation?

• The amount of cleaning agent residue left after cleaning
• The unintended transfer of residual product or contaminant from one product to the next
• The migration of packaging components into the product
• The loss of yield during cleaning activities

Correct Answer: The unintended transfer of residual product or contaminant from one product to the next

Q15. A cleaning validation protocol requires swabbing of defined worst-case locations. Which location is typically considered worst-case?

• Exposed polished surfaces with easy access
• Internal crevices, seals, dead legs, and gasket interfaces
• Large open tank surfaces used for mixing
• Exterior painted frames of equipment

Correct Answer: Internal crevices, seals, dead legs, and gasket interfaces

Q16. When using the Threshold of Toxicological Concern (TTC) approach, the TTC value is used to:

• Set microbiological action limits
• Define a conservative, generic acceptable daily intake to derive cleaning limits for unknown impurities
• Determine the optimal cleaning agent concentration
• Measure the surface roughness of equipment

Correct Answer: Define a conservative, generic acceptable daily intake to derive cleaning limits for unknown impurities

Q17. In validation, why must analytical recovery experiments mimic actual surface and extraction conditions?

• To ensure recovery values are optimistic and overestimate residues
• To provide realistic swab recovery factors that correct measured residues for method inefficiency
• Because regulators only accept swab recovery > 100%
• To avoid performing specificity tests

Correct Answer: To provide realistic swab recovery factors that correct measured residues for method inefficiency

Q18. Which statement about visual cleanliness acceptance is correct?

• Visual inspection alone is sufficient evidence of absence of residues for toxic compounds
• Visual inspection is a preliminary check but must be supported by analytical evidence for chemical residues
• Visual acceptance replaces the need for periodic re-validation
• Visual inspection is not performed in modern facilities

Correct Answer: Visual inspection is a preliminary check but must be supported by analytical evidence for chemical residues

Q19. What is the main reason for including product-to-product worst-case pairings during cleaning validation studies?

• To ensure the cleaning agent remains the same for all products
• To evaluate potential cross-contamination from high potency or low solubility donor products to sensitive acceptor products
• To reduce the number of analytical assays required
• To justify longer cleaning cycles

Correct Answer: To evaluate potential cross-contamination from high potency or low solubility donor products to sensitive acceptor products

Q20. Which corrective action is most appropriate if swab results during routine monitoring exceed cleaning validation acceptance limits?

• Ignore the result if the final product passes release testing
• Investigate root cause, re-clean, re-sample, and assess impact on batches; implement CAPA as needed
• Immediately decommission the entire facility
• Switch analytical methods to obtain better recovery

Correct Answer: Investigate root cause, re-clean, re-sample, and assess impact on batches; implement CAPA as needed

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