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Pharmaceutical Manufacturing > Quiz Finals > Flashcards

Quiz Finals Flashcards

1
Q

Device that apply an essentially dry, thin layer of coating material to tablets

A

Tablet Coating Machine

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2
Q

This is used for the preparation and storage of liquid dosage forms

A

Tanks

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3
Q

Generally, an equipment that is used in a tank for mixing various process media

A

Agitators

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4
Q

This is used for emulsions for easier agitation but are expensive

A

Ultrasonifiers

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5
Q

Employed in aerosols wherein temperature of propellant is below boiling point

A

Cold Filling Machine

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6
Q

This is used to assure that tablet hardness are within specifications

A

Tablet Hardness Tester

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7
Q

Standard for precision particle size reduction

A

Fitzmill Comminutor Machine

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8
Q

Popular tumbler blender with a mechanism of diffusion

A

V-blender

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9
Q

This is used for creams to improve consistency

A

Batch Mixers

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10
Q

This is used to disintegrate solid particles in suspensions or emulsions

A

Colloid Mills

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11
Q

The elements of control strategy which contribute to the final product quality includes In-process controls, input materials, intermediates, container closure system, and drug products.

T or F

A

T

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12
Q

The elements of control strategy which contribute to the final product quality includes In-process controls, input materials, intermediates, container closure system, and drug products.

T or F

A

T

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13
Q

The elements of control strategy which contribute to the final product quality includes In-process controls, input materials. intermediates, container closure system, and drug products.

T or F

A

T

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14
Q

Strategy implementation includes strategic leadership and evaluating results.

T or F

A

T

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15
Q

Typical conditions for Compression of tablets are done in 20 degrees Celsius with a relative humidity of 25 to 35%

T or F

A

T

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16
Q

Storage of Solid Dosage forms are typically at 35% RH.

T or F

A

F

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17
Q

A common issue that can arise from poor humidity control is product drying issue.

T or F

A

T

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18
Q

Continued Process Verification Stage 3B is on ongoing routine manufacturing.

T or F

A

T

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19
Q

Process Design determines if process is capable of reproducible commercial manufacturing

T or F

A

F

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20
Q

Steel offers good protection at 90% RH.

T or F

A

F

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21
Q

Non-ferrous metals have good storage at 30% RH.

T or F

A

T

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22
Q

This is the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality products.

A

Process validation

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23
Q

This is the research and development phase and involves defining a process for manufacturing the product.

A

Process Design

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24
Q

This stage evaluates the process designed earlier to ensure it can reproduce consistent and reliable levels of quality

A

Process qualification

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25
Q

The stage involves product sampling, analysis, and verification at various points in the manufacturing process, and requires the involvement of employees with quality control training. One of the main aims of this stage is to detect and resolve process drift.

A

Continued Process Verification

26
Q

Process validation is needed in the following instances, EXCEPT:

New employees
Totally new processes
Poor and unreliable indicator of product quality
New equipment

A

New employees

27
Q

Validation of processes, facilities and controls using historical data to provide necessary documentary evidence.

A

Retrospective Validation

28
Q

This means repeating the original validation effort or any part of it and includes investigative data.

A

Revalidation

29
Q

Establishing documented evidence prior to process implementation that a system does what it proposed to do.

A

Prospective Validation

30
Q

The following can be instances wherein revalidation can be made, EXCEPT:
Changes in the formula
Changes in administration
Changes in the production area
Changes in starting material

A

Changes in administration

31
Q

Equipment validation which is the process of demonstrating that an instrument will function according to its operational specification in the selected environment.

A

Operational Qualification

32
Q

This is the process of demonstrating that an instrument consistently performs according to specifications.

A

Performance qualification

33
Q

This is the process of demonstrating that an instrument consistently performs according to specifications.

A

Performance qualification

34
Q

This defines the functional and operational specifications of an instrument and details for the selection of the supplier.

A

Design qualification

35
Q

This establishes that an equipment is received as designed as specified and properly installed in the selected environment.

A

Installation qualification

36
Q

The following are benefits of Quality by Design, EXCEPT:
Better understanding of the process
Better control of changes
Loss batch fallure
Reduction of pre-approval submissions

A

Reduction of pre-approval submissions

37
Q

Prospective and dynamic summary of the quality characteristics of a drug product ideally will be achieved to ensure desired quality.

A

Target Product Quality Profile

38
Q

Planned set of controls derived from current product and process understanding that assures process performance and product quality.

A

Control Strategy

39
Q

This is a process of breaking down coarse particles to finer ones.

A

Milling

40
Q

Multi-dimensional combination of input and variables and process parameters to provide assurance of quality.

A

Design Space

41
Q

This is the process of transferring the solution in a suitable container. Also, constant mixing must be observed to maintain homogeneity.

A

Filling

42
Q

Method of decreasing the particle size of a solid by triturating it in a mortar or spatulating it on an ointment slab or pad with a small amount of a non-soluble liquid or molten base.

A

Levigation Method

43
Q

Milk

A

Active ingredient

44
Q

Sodium citrate

A

Buffering agent

45
Q

Turmeric

A

Active ingredient

46
Q

Potassium carbonate

A

Alkalinizing agent

47
Q

Titanium dioxide

A

Opacifying agent

48
Q

Hydrous citric acid

A

Acidifying agent

49
Q

Peppermint oil

A

Odorant

50
Q

Purified water

A

Solvent

51
Q

Sodium benzoate

A

Preservative

52
Q

Acacia powder

A

Suspending agent

53
Q

Reciprocating die process

A

Capsule

54
Q

Direct compression

A

Tablet

55
Q

Incorporation

A

Cream

56
Q

Dry granulation

A

Tablet

57
Q

Plate process

A

Capsule

58
Q

Wet granulation

A

Tablet

59
Q

Fusion method

A

cream/ointment

60
Q

Dispersion Method

A

Cream

61
Q

Rotary die process

A

Capsule

62
Q

Trituration

A

Cream

Pharmaceutical Manufacturing (9 decks)

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