UNIT 5 : CLEANING VALIDATION:(MULTIPLE CHOICE

QUESTIONS)
1. The human eye is capable of detecting levels of
a. 100 µg per 4 sq .in
b. 25 µg /sq .in
c. Both a and b
d. None of these

2. CVMP Stands for

a. Cleaning validation master plan
b. Critical validation master plan
c. Corrective validation master plan
d. Cleaning validation manufacturing plan

3. In cleaning new equipment, equipment must be coated with

a. Protective lubricant
b. Polishing agent
c. Micro crystalline cellulose
d. All of the above

4. In cleaning new equipment,dyes used in

a. Coating the equipment
b. Testing the equipment
c. Polishing the equipment
d. None of the above

5. Cleaning and evaluation of cleaning in an important aspects of

 commissioning new equipment because it
a. Represent a time of maximum danger of contamination
b. Represent a time of minimun danger of contamination
c. Represent optimum time for safe of contamination
d. None of the above

6. PAI stands for

a. Pre approval inspection
b. Post approval inspection
c. Process approval inspection
d. Product approval inspection

7. TOC stands for

a. Total organic carbon
b. Total of constraints
c. Transfer of committee
d. Total organic compound

8. How many levels of cleaning validation?

a. 4
b. 8
c. 6
d. 5

9. In which level performed in between intermediate and final

product?
a. level 2
b. level 3
c. level 1
d. level 4

10. In cleaning validation,Level 4 is?

a. starting product
b. final product
c. Intermediate and final product
d. Intermediate product

11. Anlytical Methods used for cleaning?

a. HPTLC
b. GC
c. ELISA
d. All of the above

12.Cleaning validation Report approved by?

a. Quality Assurance person
b. manufacturing person
c. Microbiologist
d. plant manager

13.Sampling methods are?

a. swabbing
b. Rinse sampling
c. both 1 and 2
d. Bioassay

14.In which method of sampling solvent is collected ?

a. swabbing
b. Rinse sampling
c. Direct sampling
d. Indirect sampling

15.In microbial contamination, acceptance limit for Bacterial

count is?
a. NMT 20 CFU
b. NMT 02 CFU
c. 3)NMT 30 CFU
d. NMT 200 CFU

16.In microbial contamination ,acceptance limit for mold count is?

a. NMT 02 CFU
b. NMT 20 CFU
c. NMT 25 CFU
d. NMT 23 CFU

17.Which form of contamination is particularly insidious

a. Cross contamination with active ingredients
b. Microbiological contamination
c. Contamination by cleaning
d. Contamination by miscellaneous materials
 18.Factors to consider in setting limits of cleaning validation
except
a. The nature of the primary contaminating product
b. The medical dosage of the primary contaminating product
c. The toxicity of the primary contaminating product
d. Residues of active ingredients

19.In cleaning validation class 100 is for

a. parentertal
b. solid
c. semi solid
d. gel

20. In regulatory requirement,probability of a non sterile unit

must not exceed
a. 1 in 106
b. 1 in 10
c. 1 in 103
d. 1 in 105

21.Factors to consider in setting limits of cleaning validation

a. Batch size of the product
b. Nature of cleaning process
c. The inherent difficult of cleaning validation
d. Solubilty of primary contaminating product in cleaning media
e. All of the above
 22. Cleaning validation master plan also called as
a. stand alone document
b. stand alone protocol
c. stand alone process
d. stand alone product

23. Non-specific method for cleaning validation are

a. Visible,
b. Infrared,
c. Total Organic Carbon (TOC)
d. All of the above

24. Method used for monitoring cleaning procedure:

a. UV-Visible,
b. Infrared,
c. Total Organic Carbon (TOC)
d. GC

25. What is PLC in validation of computer system?

a. Programmed logic controller
b. Project logic controller
c. Product logic controller
d. None of the above

26. Documentation requirements-Several activities associated

with validation of the cleaning processes may generate
 documentation, which may be addressed in the CVMP. Except
a. Cleaning validation protocol
b. Cleaning validation report
c. OOS
d. OOT

27. Area of location of mixer blades for swab sampling is...

a. 200 sq.in.
b. 400 sq.in.
c. 20000 sq.in
d. 100 sq.in

28. Least soluble drug ,most important for cleaning purpose

and represent worst case products is
a. Drug A
b. Drug B
c. Drug C
d. Drug D

29. Sensitivity of Analytical method is known

parameter,described by
a. LOD
b. LOQ
c. TOC
d. Both a and b
 30. Approach to setting limit can be determined by
a. Nature of the residues
b. Residue of active ingredients
c. Nature of primary contaminating product
d. None of the above

31.General approach to sampling provides specialized sampling

,such as Rodac plate for ___ and coupan sampling for_______
,resp.
a. Bioburden and detergent
b. Active and bioburden
c. Detergent and active
d. Detergent and bioburden

32. clean-Out-Of-Place Method, Cleaning of disassembled

equipment is performed for
a. installing central washing machine.
b. Installing CIP Cleaning systems
c. Contract analytical testing facilities
d. Installation of manufacturing equipment

33. None detected Means

a. No residue present
b. Level of residue was below the level of detection
c. Residue in limit
 d. None of the above

34. For very soluble materials , the percentage recovery may

be as High
a. 99.9%
b. 98%
c. 99%
d. 96%

35. MACO stands for

a. Maximum allowable carryover
b. Minimum allowable carryover
c. Maximum acceptance carryover
d. Minimum acceptance carryover

36. ADI stands for

a. Acceptable daily intake
b. Accuracy daily inprocess
c. Attitude directional indicator
d. None of the above

37. Ultra violet light indicates -

a. Black
b. Blue
c. Violet
d. Indigo
 38. COP stand for
a. Clean out of place
b. Cleaning out process
c. Cleaning of product
d. Cleaning operations

39. Objective of validation protocol Is to demonstrate that the

cleaning process is consistent and effective in
a. Removing residues of product
b. Cleaning agents
c. Bacteria
d. All of the above

40. Sample surface areas usually vary from

a. 25 sq.cm to 100 sq.cm.
b. 15sq.cm to 50 sq.cm.
c. 10sq .cm to 25sq.cm.
d. 50sq.cm to 50sq.cm.

41.Rinse samples is also known as

a. indirect method
b. direct method
c. analytical method
d. none of the above

42. dividing total residue limit among various pieces of

 manufacturing tank surface area_____sq.ft.
a. 21
b. 22
c. 23
d. 24

43. dividing total residue limit among various pieces of

manufacturing tank oral limit
a. 1.24007
b. 1.23006
c. 1.11016
d. 1.00223

44. dividing total residue limit among various pieces of

manufacturing tank iv limit
a. 0.0074
b. 0.0072
c. 0.0075
d. 0.0073

45. dividing total residue limit among various pieces of

transfer tank surface area
_____sq.ft.
a. 28
b. 27
c. 45
d. 23
 46. dividing total residue limit among various pieces of
transfer tank oral limit
a. 1.24007
b. 1.23006
c. 1.11016
d. 1.00223

47. dividing total residue limit among various pieces of holding

tank surface area ____sq.ft.
a. 98
b. 27
c. 45
d. 23

48. dividing total residue limit among various pieces of holding

tank oral limit
a. 5.28378
b. 6.25428
c. 2.42623
d. 1.45574

49. dividing total residue limit among various pieces of holding

tank iv limit
a. 0.0148
b. 0.0381
c. 0.0322
 d. 0.0089

50. Swab sampling is also know as

a. direct surface sampling method
b. indirect method
c. analytical method
d. none of the above

51. A swab recovery study is performed

a. to determine the ability of the swab to quantitatively
remove the contaminant from the surface sampled.
b. based on the analytical determination of a sample of the
last rinsing solvent (generally water) used in the cleaning
procedure.
c. physical removal of residue left over on a piece of
equipment after it has been cleaned and dried.
d. None of the above

52. Revalidation shall be carried out

a. If the solubility of the new product being added is less than
the previously considered worst-case product.
b. If the potency of the new drug is lower than the previous
worst case product.
c. Change or any major modification to the equipment, which
has significant effect on the contact surface area.
d. All of the above

STERILIZATION VALIDATION:
 53. 3 principles involved in the validation process for sterile
products is:
a. To build sterility into a product
b. To demonstrate maximum level of probability that
sterilization methods have established sterility to all
units of batch
c. To provide greater assurance of the results of the end
product sterility test
d. All of the above

54. The relationship of concentrtion or population of living

cells and time exposure may be
a. Liner
b. Non- linear
c. Both a and b
d. None of the above

55. D value is important in the validation of sterilization

process for:
a. The type of microorganism used as the biological indicator
b. The formulation components and characteristics (e.g., pH).
c. The surface on which the micro-organism is exposed (glass,
steel,plastic, rubber, in solution, dry powder, etc.).
d. The temperature, gas concentration, or radiation dose of the
particular sterilization process
e. All of the above

56. D values are determined by

a. survivor-curve method
b. fraction-negative method
c. both a and b
d. none of the above

57. survivor-curve method is based on:

a. plotting the log number of surviving organisms vs an
 independent variable
b. samples containing identical spore populations are treated in
identical manner and determining the number (fraction) of
samples still showing microbial growth after treatment and
incubation
c. both a and b
d. none of the above

58. fraction-negative method :

a. samples containing identical spore populations are treated in
identical manner and determining the number (fraction) of
samples still showing microbial growth after treatment and
incubation
b. plotting the log number of surviving organisms vs an
independent variable
c. both a and b
d. none of the above

59. coolest location in the sterilizer must be exposed to an

equivalent time of at least _________of exposure to a
temperature of at least __
a. 8min,121deg cel
b. 4min,121 deg cel
c. 6min,15 deg cel
d. 9min,15 deg cel

60. 3 ways to decrease B value:

a. reducing the bioburden A of the bulk product
b.
 c. increasing the equivalent exposure time FT,
d. Employing a micro-organism with a lower D value at the
specified temperature
e. All of the above

61.Basic Principles In The Validation Of Sterile Products:

a. Written documentation
b. Manufacturing parameters
c. Testing parameters
d. In-process controls
e. Final product testing
f. All of the above

62. 5 major steps are involved in approaching the validation of

a sterile process:
a. Select or define the desired attributes of the product
b. Determine specifications for the desired attributes
c. Select the appropriate processes and equipment
d. Develop and conduct tests that evaluate and monitor the
processes, equipment, and personnel
e. Examine the test procedures themselves to ensure their
accuracy and reliability.
f. All of the above
63. Moist heat sterilization must be
a. Saturated steam under pressure
b. Unsaturated steam under pressure
c. Both a and b
d. All of the above

64. Validation of steam sterilization involves:

a. General consideration
b. Qualification and calibration
c. Heat distribution studies
d. Heat penetration studies/Load Cool Point
e. All of these

65. VPHP stands for:

a. Vapor Phase Hydrogen Peroxide
b. Verification of product having peroxide
c. Vapour permeability hydrogen peroxide
d. None of the above

66. The basic steps involved in the process of VPHP are

a. Dehumidification
b. Conditioning
c. Sterilization
d. Aeration
e. All of the above

67. 5 steps that must be part of the validation protocol:

a. Cycle development
b. Temperature distribution
c. Vapor distribution
d. Biological challenge
e. Aeration verification
f. All of the above
 68. Medium consideration for use in product simulation test
except
a) Selectivity
b) Clarity
c) Filterability
d) Turbidity

69 Frequently used media due to its low Selectivity and relatively low
cost
a. Soyabean casein digest (SCD)
b. Nutrient broth
c. Agar media
d. None of the above

70. Which are the media incubation parameters

a. Techniques
b. Time
c. Temperature
d. Positive control
e.All of the above

71.Conventional hot air oven also called as tunnel system

a. True
b. False

72. Accuracy of thermocouples should be +_ 0.5 degree c in

sterilization unit
a. True
b. False

BY :
Poonam Rajesh Pardhi
M.Pharm
QA