3.

GMP Element 1 (MS1514:2009),

The Confusion Among Consultants
Lecturer: Dr. Maaruf Abd Ghani
Members : Laila Liyana Mohd Noor (P68050)
Nursheila Mustafa Muin (P67316)

Ministry of Healths GMP Guidelines
Element 1-Premise and Facilities
Element 2-Operation Control Procedures and
Practices
Element 3-Sanitation and Maintenance
Element 4-Personnel
Element 5-Transportation and Distribution
Element 6-Traceability
Element 7-Internal Audit
Element 8-Training

Element 1- Premise and Facilities
Sub-Element 1

Location
Premises
Design
Construction & Structure walls, ceiling, floors, windows & doors
State of repair
Drainage and Waste Disposal
Plant Layout
Zonning clean, dry, wet, high care, etc.
Movement of goods and people
Facilities
Toilets, Changing Rooms & Lockers
Personnel Hygiene
Stores
Water Supply
Lighting & Ventilation
Machines & Equipment
Made of, type and design

PREMISE
Premise
Design (layout)

There are 3 choices in overall plant layout that can
cause confusion among Consultants:
Straight-through
U shaped
L shaped

Design Layout
Straight-through U shaped L shaped
elongated or large area in between or smaller area for corner lot area
shipping and receiving are at
opposite ends of the
building
shipping and receiving on
one side
shipping and receiving are at
different ends of the
building
relatively simple expansion expansion more complex simple expansion
reduce the number of
contamination
increase labor productivity reduce the number of
contamination
Layout
For the best layout, some of the expected benefits
through the final designs are:
safe working environment,
reduce material handling cost,
reduce number of lift-trucks needed,
increase employees efficiency, and
reduced waste

Construction & Structure
The processing plants must be:
constructed with approved materials and maintained under hygienic,
sanitary conditions
construction materials of the equipment, walls, floors, ceilings, doors,
windows, and fixtures should be safe, non-toxic and meet approved
standards for use in a food processing facility
avoid accumulating dirt and can be easily cleaned and sanitized
Materials of walls, floors, ceilings, doors and
windows must be choose according to the:
working area
area size
companys budget
clean ability
durability and
safety
Floor
Type of floors that were usually used such as:
tiles
concrete
epoxy sealed concrete
polyurethane sealed concrete
stainless steel floor and others
Floor
Tiles
disadvantage: tiny space of each tile block - can cause dirt
accumulation and difficult to clean
many types of tiles floors with different color, shape,
roughness and design


Tiny space
Floor
Uncoated Concrete
was proven with low growth of
bacteria on its surface
the rough and porous nature makes
it difficult to clean and remove
attached bacteria
for these reasons it is not suitable
for use in food production facilities
with strict hygiene requirements
to overcome this problem: the
concrete must be sealed with other
material such as epoxy or
polyurethane
Floor
Epoxy Polyurethane (PU)
not recommended for outdoor use
- cannot handle the constantly fluctuating
state of outdoor concrete
works well indoors and outdoors
not so effective at reducing bacterial
levels on surface
effective at reducing bacterial levels on
surfaces
industrial grade epoxies are very oil and
chemical resistant
highly resistant to oil and most
contaminants
forms a very strong bond to concrete forms a weak bond when applied directly
to concrete and usually used a topcoat
with an epoxy based primer
has been in use for 65 years has been in use for 20+ years
Floor
Epoxy
Polyurethane (PU)
Ceiling
It is not good practice to use
acoustic tile for the ceiling in a
food plant.
The hidden side of the ceiling tends
to be come dirty and is a potential
source of contamination.

In fact, it is not recommended to
have any ceiling in a food plant, if
possible.
Good food plant design uses a
precast roof structure in which case
a ceiling is not needed.
Ceiling
The most recommended ceiling installation is
the concrete slab

Floors, walls, ceilings, and doors in any area where food
is handled or stored:
should not absorb water
should be easy to scrub
keep clean
the materials selected should not be susceptible to cracks,
scars, or pitting when exposed to sanitizer and normal
conditions of use
must avoid dirt accumulation or entrap food particles- can
lead to contamination of food products

The important features - joints between vertical
elements (e.g., columns or walls) and floors should
be coved (rounded)
to prevent dirt accumulation
This features is overlooked among few consultants
it is not stated specifically in GMP guideline
Columns should be encased in concrete with tapered
tops
If there is no cove, the areas where floors and walls
meet need to have a waterproof seal
to prevent water and food debris from accumulating in the
area or behind the walls or under the floor

Drainage & Waste Disposal
In a wet facility, the areas may contain water,
grease, blood, fat, syrups and other materials
on the floor
Such areas typically must have hub or trench
drains - handle large quantities of water, but
difficult to clean and can harbor microbes
Properly sloped floors should be constructed
to avoid water reservoir that can cause
contamination
Removable grates or plugs on drains should be
installed to protect against pests
Drains should be regularly cleaned and
sanitized

Drains in the processing area can be
uncovered and it should be made with
suitable materials
Guideline standard:
The drainage channels must in fully or partially open
It need to be so designed as to ensure that waste does not
flow from a contaminated area towards or into a clean area,
in particular an area where foods likely to present a high risk
to the final consumer are handled

Waste Disposal
Ideally, waste, whether liquid or solid,
should be stored in closed containers that are not
next to open entries into the plant.
waste containers and the areas around them must
also be kept clean to eliminate food that can attract
pests.
these containers and the areas around them should
also drain properly to eliminate water that can attract
pests.
Good Practice
Bad Practice

TOILET
A well-designed toilet has to be:
Clean and dry
Well ventilated
Easy to maintain
Carefully planned layout
Handicap friendly
Ventilation System
Proper ventilation is one of the highest priorities

Ineffective ventilation can make a toilet
unbearable, even if it is well designed

Effective ventilation ensures that vitiate air is
quickly extracted and helps to avoid dampness
and subsequent growth of mould on floor, wall
and ceiling

The toilet air should be extracted to the outside
by a mechanical ventilation system at a rate not
less than 15 air charges per hour
Ventilation System

There are generally two types of air flow
configurations used in toilet:

Non-unidirectional
Unidirectional
Non-unidirectional air flow Unidirectional air flow
Single pass air flow pattern

Also called 'laminar' air flow

Used where low air borne contaminant
levels are required and where internal
contaminants are the main concern

Contamination generated in the room is
generally swept down and out
Used in rooms where major contamination
is expected from external source

Turbulent flow enhances the mixing of low
and high particle concentrations,
producing a homogenous particle
concentration
Where unisex facilities are
provided, it shall:

Be located in a self contained
compartment offering full privacy by way
of full height doors and walls

Contain a water closet (WC) pan, basin,
sanitary towel disposal equipment, but no
urinal bowls

Be located so that access is not via an area
restricted to one sex


Males facilities may include urinal bowls

Sanitary facilities for females shall have
provision for sanitary towel disposal
equipment


Where separate facilities are
provided, it shall:
Toilet Layout
Various screening arrangements for toilets showing the visibility from external area
Doors have been replaced by offset entrance maze which
blocks the view yet allows easier, hands-free access
Off-set entrance maze without doors
Toilet Layout
Single entrance/exit plans provide the path of
personnel, not cross each other

Dispensing the entrance door helps to:
improve the ventilation
minimizes hand contact for hygiene reasons


Materials

FLOOR

Non-slip ceramic tiles, natural stone, homogeneous
tiles, terrazzo

Non-slip homogeneous tiles are often selected:
durable and relatively easy to clean and well
maintained

Another alternative: ceramic tiles or wall cladding



Calcium silicate board

Better suited for applications
where the ceiling is not required

For renewal of ceiling finishes, it
is far less expensive to repaint


Suspended ceiling tiles

If there is piping above the
ceiling, for example, suspended
tiles will permit easy access for
maintenance and repaired in the
event of spot damage

CEILING
Materials
Materials
WALL

Ceramic tiles, natural stone,
homogeneous tiles, stainless steel,
enamelled steel panels, glass block,
aluminium panels, phenolic cladding


Toilet Partition/Divider
Phenolic Partition

A type of industrial strength plastic

Vandal resistance

Easy cleaning

Highly resistant to water beading and
bacterial buildup

Very hard to scratch, chip, dent or gouge it
with pens or pocket knives

If it is spray painted, it is very easy to wipe
them clean without any traces of color
remaining

Solid Plastic

Economical

Resistant to damages from scratches
and dents

Water resistant

Bacterial growth is minimized
Toilet Partition/Divider
Stainless Steel

Rust proof

Never use anything acidic because it
will permanently damage the steel

Expensive, but well worth the money
if the factory has the budget

Baked Enamel

Most sensitive material

Must be cleaned with mild soap
solutions, lukewarm water and a soft
cloth

Chemical cleaners and particularly
strong detergents should be avoided

Male Toilet
The access entrance to male toilets
should not open directly to the urinal
area

Avoid entrances opening onto a wall
surface with the mirror reflecting the
urinals

As to keep the urinal areas dry,
stainless steel grating could be installed
over the drainage and below the urinal
bowls
Wash Basin
Electronically controlled taps should be considered. Sensor
controlled taps with their precise flow settings and positive
shutoff characteristics, providing adequate water flow when it
is required

Further to this, it will minimize hand contact and as an effort
to conserve water

Liquid soap dispensers, sanitizers, paper towel dispenser or
hand dryer and bins should be installed adjacent to the wash
basins

Personnel Facilities
Changing room
Lockers
Reasons for the confusion among
Consultants
Education
Training
Experience
THANK YOU