Cleaning validation of equipment MCQs With Answer

Introduction:

This quiz collection on Cleaning Validation of Equipment is designed specifically for M.Pharm students preparing for examinations and practical responsibilities in pharmaceutical manufacturing. It covers core concepts including regulatory expectations, sampling techniques (swab, rinse, visual), analytical methods (HPLC, TOC, ATP), worst‑case product selection, acceptance criteria setting, recovery studies, revalidation triggers, and practical troubleshooting. Questions emphasize scientific rationale behind limits, selection of sampling sites, and interpretation of analytical results. Use these MCQs to test your understanding, identify knowledge gaps, and reinforce best practices necessary for developing robust cleaning validation protocols aligned with current regulatory and quality expectations.

Q1. What is the primary objective of cleaning validation for pharmaceutical equipment?

• To verify that cleaning chemicals are effective in removing microbes only
• To document routine cleaning schedules without testing residues
• To ensure removal of product, cleaning agent and microbial residues to scientifically justified acceptance limits
• To validate visual cleanliness only

Correct Answer: To ensure removal of product, cleaning agent and microbial residues to scientifically justified acceptance limits

Q2. Which sampling methods are most commonly used to detect chemical residues on equipment surfaces?

• Only visual inspection
• Swab and rinse sampling
• Air sampling exclusively
• Microbial contact plates only

Correct Answer: Swab and rinse sampling

Q3. What is a commonly adopted standardized swab area for cleaning validation sampling?

• 1 cm2
• 25 cm2 (for example 5 × 5 cm)
• 500 cm2
• No defined area is ever used

Correct Answer: 25 cm2 (for example 5 × 5 cm)

Q4. Which factors are most important when selecting a worst‑case product for cleaning validation?

• Color and branding only
• Potency (dose), solubility, toxicity and batch size
• Supplier location and packaging type
• Equipment age and operator experience only

Correct Answer: Potency (dose), solubility, toxicity and batch size

Q5. What is the analytical method requirement relative to established acceptance limits?

• Method limit of quantification (LOQ) must be higher than the acceptance limit
• Method LOQ should be at or below the established acceptance limit
• Method sensitivity is irrelevant for cleaning validation
• Any visual method is acceptable if documented

Correct Answer: Method LOQ should be at or below the established acceptance limit

Q6. Which statement best describes Total Organic Carbon (TOC) in cleaning validation?

• TOC is specific for a single API and cannot detect detergents
• TOC is a non‑specific indicator of organic residues including detergents and many APIs
• TOC measures only inorganic residues
• TOC replaces the need for chemical assays in all cases

Correct Answer: TOC is a non‑specific indicator of organic residues including detergents and many APIs

Q7. Which of the following is true about ATP bioluminescence in cleaning assessment?

• ATP specifically quantifies residual API mass on surfaces
• ATP indicates biological (organic) contamination and is not specific for chemical residues
• ATP can replace HPLC for detection of potent actives
• ATP measures total inorganic contamination

Correct Answer: ATP indicates biological (organic) contamination and is not specific for chemical residues

Q8. What is the preferred scientific basis for establishing cleaning acceptance limits?

• Arbitrary limits chosen by manufacturing staff
• Toxicological‑based limits such as permitted daily exposure (PDE) or acceptable daily intake (ADI)
• Visual judgment alone
• The most convenient analytical LOQ available

Correct Answer: Toxicological‑based limits such as permitted daily exposure (PDE) or acceptable daily intake (ADI)

Q9. What is the primary purpose of recovery (swab efficiency) studies in cleaning validation?

• To evaluate microbiological kill rates
• To determine the ability of the swab and extraction procedure to recover a known amount of residue from surfaces
• To test operator compliance with gowning procedures
• To measure the color change on swabs

Correct Answer: To determine the ability of the swab and extraction procedure to recover a known amount of residue from surfaces

Q10. Which event typically triggers revalidation of cleaning procedures?

• A small change to administrative paperwork only
• Change in product, formulation, cleaning agent, equipment or after repeat failures
• Every operator takes a vacation
• Changing the room paint color

Correct Answer: Change in product, formulation, cleaning agent, equipment or after repeat failures

Q11. When should rinse sampling be preferred over swab sampling?

• For localized hard‑to‑reach deposits
• For homogeneously soluble residues in closed or circulating systems
• Rinse is never appropriate
• Only for microbiological testing

Correct Answer: For homogeneously soluble residues in closed or circulating systems

Q12. What is the recommended practice regarding visual cleanliness prior to taking analytical samples?

• Analytical sampling can be done regardless of visual residues
• Equipment should be visually free of product residues before analytical sampling
• Visual inspection is unnecessary if TOC is used
• Visual inspection should be skipped to save time

Correct Answer: Equipment should be visually free of product residues before analytical sampling

Q13. How should residues of cleaning agents be addressed in cleaning validation?

• They can be ignored if the product residue limit is met
• They must be measured or justified as non‑hazardous and removed to acceptable levels
• Assume cleaning agents are fully removed by dilution
• No specific assessment is needed for surfactants

Correct Answer: They must be measured or justified as non‑hazardous and removed to acceptable levels

Q14. Which preceding product condition often represents the worst case for carryover risk?

• High solubility and large batch size
• High potency, low solubility and large batch size
• Low potency and high solubility
• Products with identical formulations

Correct Answer: High potency, low solubility and large batch size

Q15. What is the role of placebo or simulated product runs (dry runs) in cleaning validation?

• They replace the need for analytical testing
• They can be used to help remove adherent residues and demonstrate the mechanical effectiveness of cleaning
• They are only used for packaging validation
• They are prohibited during cleaning validation

Correct Answer: They can be used to help remove adherent residues and demonstrate the mechanical effectiveness of cleaning

Q16. Which simple conservative industry rule is often used as a quick default for setting provisional carryover limits?

• 1/10 of the therapeutic dose
• 1/1000 of the minimum therapeutic dose of the previous product
• 10% of the previous batch amount
• No default rule is ever used

Correct Answer: 1/1000 of the minimum therapeutic dose of the previous product

Q17. When is the correct time to collect cleaning validation samples?

• Before cleaning begins
• After cleaning and visual inspection, but before the next production run
• During the next production run
• Randomly at any time

Correct Answer: After cleaning and visual inspection, but before the next production run

Q18. Which document is central to executing and approving a cleaning validation exercise?

• Training attendance log only
• Cleaning validation protocol and final validation report
• Marketing approval letter
• Product label artwork

Correct Answer: Cleaning validation protocol and final validation report

Q19. What is the primary purpose of rinse validation for CIP (clean‑in‑place) systems?

• To document operator time on task
• To demonstrate removal of soluble residues and homogenous cleanliness in circulating piping and vessels
• To validate packaging integrity
• To measure airborne particulates only

Correct Answer: To demonstrate removal of soluble residues and homogenous cleanliness in circulating piping and vessels

Q20. Which strategy helps reduce the number of cleaning validations required across many similar products?

• Full validation for every single product regardless of similarity
• Use of scientific risk assessment, worst‑case selection, bracketing and matrixing approaches
• Relying solely on visual inspection for similar products
• Validating only the cheapest products

Correct Answer: Use of scientific risk assessment, worst‑case selection, bracketing and matrixing approaches

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