Quiz Finals

Question 1

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

Answer 1

Tablet Coating Machine

Question 2

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

Answer 2

Tanks

Question 3

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

Answer 3

Agitators

Question 4

This is used for emulsions for easier agitation but are expensive

Answer 4

Ultrasonifiers

Question 5

Employed in aerosols wherein temperature of propellant is below boiling point

Answer 5

Cold Filling Machine

Question 6

This is used to assure that tablet hardness are within specifications

Answer 6

Tablet Hardness Tester

Question 7

Standard for precision particle size reduction

Answer 7

Fitzmill Comminutor Machine

Question 8

Popular tumbler blender with a mechanism of diffusion

Answer 8

V-blender

Question 9

This is used for creams to improve consistency

Answer 9

Batch Mixers

Question 10

This is used to disintegrate solid particles in suspensions or emulsions

Answer 10

Colloid Mills

Question 11

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

Answer 11

T

Question 12

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

Answer 12

T

Question 13

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

Answer 13

T

Question 14

Strategy implementation includes strategic leadership and evaluating results.

T or F

Answer 14

T

Question 15

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

T or F

Answer 15

T

Question 16

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

T or F

Answer 16

F

Question 17

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

T or F

Answer 17

T

Question 18

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

T or F

Answer 18

T

Question 19

Process Design determines if process is capable of reproducible commercial manufacturing

T or F

Answer 19

F

Question 20

Steel offers good protection at 90% RH.

T or F

Answer 20

F

Question 21

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

T or F

Answer 21

T

Question 22

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.

Answer 22

Process validation

Question 23

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

Answer 23

Process Design

Question 24

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

Answer 24

Process qualification

Question 25

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.

Answer 25

Continued Process Verification

Question 26

Process validation is needed in the following instances, EXCEPT: New employees Totally new processes Poor and unreliable indicator of product quality New equipment

Answer 26

New employees

Question 27

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

Answer 27

Retrospective Validation

Question 28

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

Answer 28

Revalidation

Question 29

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

Answer 29

Prospective Validation

Question 30

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

Answer 30

Changes in administration

Question 31

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

Answer 31

Operational Qualification

Question 32

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

Answer 32

Performance qualification

Question 33

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

Answer 33

Performance qualification

Question 34

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

Answer 34

Design qualification

Question 35

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

Answer 35

Installation qualification

Question 36

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

Answer 36

Reduction of pre-approval submissions

Question 37

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

Answer 37

Target Product Quality Profile

Question 38

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

Answer 38

Control Strategy

Question 39

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

Answer 39

Milling

Question 40

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

Answer 40

Design Space

Question 41

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

Answer 41

Filling

Question 42

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.

Answer 42

Levigation Method

Question 43

Milk

Answer 43

Active ingredient

Question 44

Sodium citrate

Answer 44

Buffering agent

Question 45

Turmeric

Answer 45

Active ingredient

Question 46

Potassium carbonate

Answer 46

Alkalinizing agent

Question 47

Titanium dioxide

Answer 47

Opacifying agent

Question 48

Hydrous citric acid

Answer 48

Acidifying agent

Question 49

Peppermint oil

Answer 49

Odorant

Question 50

Purified water

Answer 50

Solvent

Question 51

Sodium benzoate

Answer 51

Preservative

Question 52

Acacia powder

Answer 52

Suspending agent

Question 53

Reciprocating die process

Answer 53

Capsule

Question 54

Direct compression

Answer 54

Tablet

Question 55

Incorporation

Answer 55

Cream

Question 56

Dry granulation

Answer 56

Tablet

Question 57

Plate process

Answer 57

Capsule

Question 58

Wet granulation

Answer 58

Tablet

Question 59

Fusion method

Answer 59

cream/ointment

Question 60

Dispersion Method

Answer 60

Cream

Question 61

Rotary die process

Answer 61

Capsule

Question 62

Trituration

Answer 62

Cream