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Manufacture Lecture > Quiz > Flashcards

Quiz Flashcards

1
Q

A mechanism for DETERMINING and ASSIGNING necessary DUTIES to people so they can work together effectively

A

Organization

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2
Q

The basic element of an organization where the types of WORK just be identified and grouped logically on related elements

A

Division of responsibility

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3
Q

The basic tool that clearly defined the AUTHORITY, DUTY or RESPONSIBILITY

A

Position description

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4
Q

The organizational chart can

A

Assess strength and weaknesses in functions and personnel

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5
Q

It functions to INVESTIGATE CUSTOMER COMPLAINTS or inequities on the product

A

Central release section

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6
Q

SAMPLES retention or reserved samples withdrawn from the packaging line

A

Inspection and checking section

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7
Q

SOPs are written for the following except

A

Consumers information records

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8
Q

Examples of common product complaints except

A

Elegance

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9
Q

Stage of research which involves manufacturing requirements, reviews basic information, product control and patent application

A

Clinical research stage

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10
Q

Responsible for the conduct of STABILITY STUDIES

A

Chemical control and testing

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11
Q

Implies a procedure by which decisions are made regarding whether the production is processing as PLANNED

A

Monitoring

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12
Q

Ability of a particular formulation in a specific container to REMAIN WITHIN it’s physical, chemical, therapeutic and toxicological specification

A

Shelf-life

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13
Q

Cross contamination can come from the following except

A

Prevention of mix ups

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14
Q

The following are important document except

A

Batch records

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15
Q

To prevent microbial contamination contributed by people or is best to

A

Practice good personal hygiene

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16
Q

One for reason for inspecting the quality of the product during packaging and labeling operation is

A

To allow ease reconciliation

17
Q

In the formulation of liquid, the following consideration should be studied except

A

Organoleptic characteristics

18
Q

Used for mixing powder mixture in large volume quantity

A

V-blender

19
Q

The IPQC test that determines the durability of a tablet and it’s ability to withstand abrasion in handling, packaging and shipment, USP requires a maximum weight loss of not more than 1%

A

Friability test

20
Q

It is used for compacting the materials in the tablet machine

A

Punches

21
Q

T/F
HEPA filters are used in the filtration of parenterals

A

F - air

22
Q

T/F
Compressed gasses do not expand

A

F

23
Q

T/F
Floors with easy to clean finish are made with troweled epoxy

A

T

24
Q

Seamless surface can be achieved with heat - welded seams

A

T

25
Q

T/F
Airlocks are used to maintain pressurized differentials between rooms

A

T

26
Q

T/F
A pass through can be added through the airlock

A

T

27
Q

T/F
Furnishings in the GOWNING room are made of non-shedding materials such as stainless steel

A

T

28
Q

T/F
Gown racks can be equipped with HEPA filter above it to continually bathe garments in clean air

A

T

29
Q

T/F
A personal lockers should be located separate from the clean GOWNING area

A

T

30
Q

T/F
Restroom facilities can be located inside the GOWNING area

A

F

31
Q

T/F
Materials and equipment can enter through the pass through

A

T

32
Q

T/F
Personnel can communicate and transfer to another room in the pass-through

A

F

33
Q

T/F
Windows can be placed in exterior building walls near a clean room

A

F

34
Q

T/F
Windows should be impact-resistant type of glass or acrylic

A

T

35
Q

T/F
The higher the pressure the CLEANER the room is

A

T

36
Q

T/F
NON-UNIDIRECTIONAL airflow pattern is effective in removing particles in a clean room

A

F

Manufacture Lecture (4 decks)

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