Multiple-Choice Questions (MCQs) & answer on cleaning validation
Objective-Type Questionnaire
1.Question : According to the 1993 U.S. FDA cleaning validation guidance, cleaning validation is not required when the cleaning process is used:
A. Between batches of different products on multipurpose equipment
B. Only between batches of the same product
C. Between batches of high-potency pharmaceuticals
D. For any dedicated equipment
Answer – B
2.Question : In dedicated equipment, cleaning validation is generally not required because:
A. Cross-contamination between products cannot occur
B. Cleaning agents are always the same
C. Bioburden is never a concern
D. FDA forbids cleaning validation for dedicated equipment
Answer – A
3. Question :Cleaning validation should be considered for dedicated equipment when:
A. Production volumes are high
B. Visually clean criteria cannot be applied
C. Carryover of cleaning agents or bioburden may impact the next batch
D. The product is made in campaigns
Answer – C
4. Question : According to FDA’s Compliance Guidance Manual 7356_002, a warning letter may be issued for:
A. Over-cleaning dedicated equipment
B. Lack of demonstration of effectiveness of cleaning
C. Using too many cleaning agents
D. Campaign production
Answer – B
5. Question : The principles for determining acceptance criteria for cleaning agent residues, bioburden, endotoxin, and degradation products for dedicated equipment are:
A. Stricter than for nondedicated equipment
B. Completely different from nondedicated equipment
C. The same as for nondedicated equipment
D. Not applicable to dedicated equipment
Answer – C
6.Question : Dedicated equipment never requires cleaning validation under any circumstance.
(True / False)
Answer – False
7.Question : “Visibly clean” may be the only required criterion for between-batch cleaning of the same product.
(True / False)
Answer – True
8.Question : The FDA text implies that dedicated equipment cleaning processes should still be evaluated through risk assessments.
(True / False)
Answer – True
9.Question : It is considered best practice to document cleaning effectiveness for dedicated equipment even when visually clean is the only criterion.
(True / False)
Answer – True
Fill-in-the-Blank
10.Question : FDA guidance indicates that cleaning validation is not required when equipment is used only between batches of the __________ product.
Answer – Same
11. Question : A primary reason to consider cleaning validation for dedicated equipment is the potential carryover of __________ agents.
Answer – Cleaning
12. Question :Manufacturers should conduct __________ assessments to determine if cleaning validation is needed.
13. Question : A quality-driven reason for dedicating equipment is:
A. Reducing staff workload
B. Avoiding cross-contamination between active ingredients
C. Increasing batch size
D. Reducing cleaning time only
Answer: B
14. Question : According to PIC/S, dedicated equipment should be used for products that:
A. Are easy to clean
B. Leave residues that are difficult to remove
C. Have long shelf life
D. Are manufactured in small batches
Answer: B
15. Question : Which example is given for equipment that is difficult to clean under PIC/S?
A. Blenders
B. Fluid bed dryer bags
C. Stainless steel tanks
D. Tablet coating pans
Answer: B
16. Question : PIC/S recommends dedicated equipment for products with high safety risk such as:
A. Vitamins
B. Herbal supplements
C. Biological products or high-potency products
D. Excipients
Answer: C
17. Question : For certain allergenic ingredients like penicillin’s and cephalosporins, PIC/S requires residue limits to be:
A. Within typical cleaning limits
B. Below visible levels
C. Below the limit of detection using the best available analytical methods
D. At the same level as non-allergenic materials
Answer: C
18. Question : The use of dedicated plants may be required for:
A. Products with short expiration dates
B. All non-sterile products
C. Highly potent steroids and cytotoxic
D. Standard oral solid dosage forms
Answer: C
19. Question : ANVISA RDC No. 17 requires segregated and dedicated facilities for:
A. General tablets and capsules
B. Live biological preparations and highly sensitizing materials
C. All non-prescription products
D. Products stored at room temperature
Answer: B
20. Question : According to ANVISA, production of highly active products such as certain hormones and cytotoxic substances should occur in:
A. Shared rooms
B. Warehouse areas
C. Segregated areas
D. Open manufacturing spaces
Answer: C
21. Question : U.S. FDA draft recommendations mentioned in the text relate specifically to dedication for:
A. Vaccines
B. Vitamins
C. Beta-lactams
D. Excipients
Answer: C
22. Question : When regulatory requirements are unclear or overly strict, manufacturers should rely on:
A. Historical data only
B. Risk assessments and appropriate controls
C. Industry rumors
D. Market trends
Answer: B
23. Question : Excipients should be considered in a cleaning validation program because:
A. They always have high toxicity
B. They may affect the cleaning of a drug product
C. They are more important than the API
D. Regulatory agencies require separate excipient testing
Answer: B
24. Question : The effect of excipients on cleaning is generally more pronounced in:
A. Liquid formulations
B. Topical creams
C. Solid dosage forms
D. Injectable products
Answer: C
25. Question : Some excipients in solid dosage forms may be difficult to remove because they:
A. Are always water-soluble
B. Are designed to increase dissolution
C. Are coatings or functional materials that retard dissolution
D. Evaporate during cleaning
Answer: C
26. Question : One reason companies use laboratory cleaning studies rather than relying only on API solubility is:
A. Laboratory studies are cheaper
B. Excipients can influence cleaning difficulty
C. API solubility is irrelevant
D. Laboratory studies are not required
Answer: B
26. Question :In most cases, limits for excipients in cleaning validation protocols are:
A. Strictly required for every excipient
B. Set only for preservatives
C. Not set unless the excipient has unusual toxicity
D. Based on API potency
Answer: C
27. Question : Limits may be established for an excipient when:
A. It has no effect on product performance
B. It is very common in formulations
C. It significantly affects the next product’s performance (e.g., reduces API bioavailability)
D. It is easily removed
Answer: C
28. Question : After cleaning, excipient residues must always meet which minimum requirement?
A. Below the limit of quantification
B. Below the limit of detection
C. Visually clean equipment
D. Zero residue
Answer: C
29. Question : A surface that is not visually clean due to high excipient residue should be considered:
A. Acceptable if the API is absent
B. A minor deviation
C. A cleaning validation failure
D. Normal for solid dosage manufacturing
Answer: C
Reference: PDA-Cleaning-Validation -Technical Report No. 29 (Revised 2012).