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Manufacture Lecture > Personnel, Premises And Equipment > Flashcards

Personnel, Premises And Equipment Flashcards

1
Q

The MOST IMPORTANT ASSET in the manufacturing company are
Why?

A

People
Oversee the process

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2
Q

The CORRECT manufacture of medicinal product relies upon

A

People

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3
Q

Where the RELATIONSHIPS between the heads of production, quality control and where APPLICABLE head of quality assurance and the POSITION of qualified person’s are clearly shown

A

Organizational chart

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4
Q

People in positions should have _______________ recorded in WRITTEN JOB DESCRIPTIONS and _______________ to carry out responsibilities

A

Specific duties
Adequate authority

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5
Q

There should be no _______________ in the responsibilities of personnel concerned

A

No gaps or unexplained overlaps

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6
Q

To know WHERE TO REPORT

A

Hierarchy

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7
Q

The MANUFACTURER should provide TRAINING for all the personnel whose duties take them into

A

Production
Storage
Control laboratories

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8
Q

NEWLY RECRUITED should receive

A

Training appropriate to the duties assigned

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9
Q

Personnel working in areas where ______________ should be given specific training

A

Contamination is a hazard

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10
Q

They should NOT BE TAKEN into the PRODUCTION and QC areas

A

Visitors
Untrained personnel

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11
Q

Personnel hygiene
All personnel should receive _______________ upon recruitment

A

Medical examination

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12
Q

No person affected by an _______________ or having _______________ on the exposed surface of the body is engaged in the manufacture of medicinal products.

A

Infectious disease
Open lesions

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13
Q

Personnel should wear _______________ appropriate to the operations to be carried out

A

Protective garments

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14
Q

Most COMMON SOURCE of contamination

A

Skin

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15
Q

What department wears LABORATORY GOWN ONLY

A

QC
R&D

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16
Q

Where should eating, drinking, chewing or smoking or it’s storage should be PROHIBITED

A

Production
Storage

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17
Q

DIRECT CONTACT should be avoided between

A

Operators hand
Product
Equipment

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18
Q

Personnel should be INSTRUCTED to use what facility

A

Hand-washing facility

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19
Q

Premises and equipment must be _______________ to suit the operations to be carried out

A

Located
Designed
Constructed
Adapted
Maintained

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20
Q

Used to CALCULATE building system equipment CAPACITIES and aid in the SELECTION of appropriate types of equipment

A

Design parameter

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21
Q

Organization consistent with the level of NONVIABLE and VIABLE particulate contamination

A

Cleanliness classification

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22
Q

Largely determines the CLASS OF CLEANLINESS that can be maintained during a given operation

A

Air change rate

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23
Q

NON-UNIDIRECTIONAL FLOW clean rooms rely on ____________ to continuously remove contaminants

A

Air dilution
General ceiling

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24
Q

More effective in continuously sweeping particles from the air due to the PISTON EFFECT created by the uniform air velocity

A

Unidirectional flow

25
Q

It should be maintained between ADJACENT AREAS with the CLEANER area having the

A

Higher pressure

26
Q

MINIMIZE infiltration of external contamination through LEAKS and OPENING/CLOSING of doors

A

Pressurization

27
Q

What is the MAIN CONCERN of temperature control

A

Occupant comfort

28
Q

68-70 F

A

Laboratory coat

29
Q

66 F

A

Bunny suit

30
Q

Range for HUMIDITY REQUIREMENT

A

30-60% RH

31
Q

Biopharmaceutical materials sensitive to HUMIDITY VARIATIONS or excessively high or low values may require

A

Stringent controls

32
Q

Amount of WATER VAPOR in the air

A

Humidity

33
Q

It should SUPPORT the process contained within the clean room

A

Facility layout

34
Q

What shape is EASIEST to accommodate

A

Rectangular

35
Q

Facility layout parts ATTENTION to

A

Airflow pattern

36
Q

In facility layout, the facility should accommodate movement of

A

Equipment
Material
Personnel

37
Q

Room BETWEEN the clean room
UNRATED or LESS clean
Can serve as a GOWNING AREA

A

Airlocks or anteroom

38
Q

PURPOSE of an airlock

A

Maintain pressurization differentials between spaces of different cleanliness

39
Q

Certain airlocks may be designed for equipment which is known as

A

Material air lock

40
Q

It is for airlock doors to PREVENT opening of both doors SIMULTANEOUSLY

A

Interlocks

41
Q

Airlock is intended to

A

SEPARATE clean areas from unclean

42
Q

It facilitates SUPERVISION and for SAFETY

A

Windows

43
Q

It can be a SOURCE OF LEAKAGE= Contaminants entering

A

Window

44
Q

Window is placed to permit VIEWING of operations in order to minimize

A

Entering of non-cleanroom personnel

45
Q

The windows should be

A

Impact-resistant glass or acrylic
Fully glazed

46
Q

It is for the TRANSFER of products from uncontrolled areas into the clean room.

A

Pass-through airlock

47
Q

The pass-through may include

A

Speaking diaphragm, intercom or telephone

48
Q

A cart-size pass-through can

A

Simplify the movement of carts

49
Q

Typical material for carts

A

Stainless steel

50
Q

GOWNING rooms should be designed to support the

A

Garment protocol

51
Q

A GOWNING room may have

A

Wall or floor mounted coat rack
Bench
Full length mirror : self-inspection
Storage : new packaged garments
Bins : soiled garments

52
Q

It should be located OUTSIDE the gowning room or in an anteroom SEPARATE from gowning area

A

Personal lockers

53
Q

It should be located OUTSIDE the gowning room or in an anteroom ADJACENT to the gowning area

A

Restroom facilities

54
Q

The wall should be STRONG enough to WITHSTAND

A

Repeated impact without deterioration

55
Q

Walls should be __________ between architectural features

A

Rounded
Easy to clean corners
Smooth transitions

56
Q

Entry should be through airlocks

A

Doors

57
Q

Commonly used for FINISHES for biopharmaceutics clean rooms include

A

Sheet vinyl
Troweled epoxy
Epoxy paint

58
Q

How is sheet vinyl installed

A

Heat-welded
Chemically fused seams

59
Q

If there is a CRACK on the floor what will you do

A

Report immediately to engineering

Manufacture Lecture (4 decks)

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