DHM 2033

HALAL MALAYSIA STANDARD & CERTIFICATION

CHAPTER 8

GOOD
MANUFACTURING
PRACTICES (GMP)
Content of Discussion
◻ Introduction
◻ Establishment : Premise and Facilities
◻ Control of Operation
◻ Maintenance and Sanitation
◻ Workers
◻ Transportation and Distribution
◻ Traceability
◻ Internal audit
◻ Training
 Introduction : Good Practice
▪ Activity of the quality assurance which ensures
that food products and food related
processes are consistent and controlled to
assure quality procedures in food systems

▪ General categories :
i. Directly connected with food (i.e.: GMP good
manufacturing practice)
ii. Indirectly connected with food issues (i.e.: GRP good
research practice)
iii. Needed be not existing in reality (i.e.: GKP good
housekeeping practice)
 Introduction : Good Practice
Good practices directly conected to food issues

i. good agricultural practice (GAP)

ii. good catering practice (GCP)
iii. good housekeeping practice (GKP)
iv. good hygiene practice (GHP)
v. good laboratory practice (GLP)
vi. good manufacturing practice (GMP)
vii. good retail practice (GRP)
viii. good storage practice (GSP)
ix. good transport practice (GTP)
Introduction : What GMP

Good Manufacturing Practices

❑ “ A set of regulations, codes

and guidelines that control the
operational conditions within a
food establishment allowing for
the production of safe food”
(Reference: MS 1514:2009)
Introduction : What GMP

❑ Consists as a series of guidelines aimed at ensuring

that food and drink products are consistently
manufactured to a quality appropriate to their
intended use.

❑ Cover all aspects of food production, distribution

and storage and provide details of how the appropriate
controls should be set up and maintained
 Introduction : What GMP
◻ Consists of practical procedures and processes -
ensure quality system, provide consistent manufacture
and control of products by qualitative criteria and
conformity assessing criteria with intended purpose
as required by the authorisation and specification.

◻ Part of the quality assurance (QA) which ensures that

food products are consistently produced and
controlled to the quality standards appropriate to their
intended use.
Introduction : Why GMP

i. To help food industries in achieving a higher

food standards
ii. To produce safe and good quality
products
iii. To reduce the risk of contamination
iv. Enable the implementation of HACCP to be
more focusing on food safety
v. Customer requirement
vi. Export requirement for certain countries
 Introduction : GMP References **

** in Malaysia
Cross – References of Guidelines
Introduction : GMP References **

MS1514: 2009 differs with GMP Guidelines from

MOH for the stated aspects below:
i. Comprises of 10 elements as compared
to 8 elements as in GMP Guidelines

ii. Internal inspection composed in the 8th

Element in MS 1514 which it is stated in
7th Element in GMP Guidelines
COMPARISON MESTI, GMP, HACCP

DHH 3053 Halal Certification & QM : GMP

Element 1 :
Establishment : Premise and Facilities
i. Location

ii. Premise and Space/Room

✔ Design and Layout
✔ Internal Structures and Fittings

iii. Equipment
✔ Design
✔ Food control and monitoring equipment
Element 1 :
Establishment : Premise and Facilities
iv. Facilities
a) Water supply
b) Drainage and waste disposal
c) Cleaning
d) Personnel hygiene facilities
✔ Toilet facilities
✔ Hand washing facilities
e) Temperature control
f) Air quality and ventilation
g) Lighting
h) Storage
Sub Element 1.1 :
Location
Location selection :
❖ Industrial area
❖ Free from industrial pollutants
❖ Not prone to flooding
❖ Areas not prone to pest infestation
❖ Areas where wastes, either solid or
liquid can be removed effectively
 Sub Element 1.2 :
Premise and Space/Room
❖ Overall plan layout shall avoid cross
contamination
❖ Facilities arrangement enabling easy access for
cleanliness and pest control monitoring
❖ Size of equipment and facilities suites the space
of the room/area
❖ Proper plan layout should follow “U”, “the
productL” or one way processing flow
❖ Reduce the risk of cross contamination and more
efficient - follows the process flow of
Sub Element 1.2 :
Design and Layout
Example of
“U” shaped
layout plan
 Sub Element 1.2 :
Premise and Space/Room

Zoning

❑ Rooms and spaces should be separated

according to suitable zoning
i. Wet area
ii. Dry area
iii. Temperature needs
iv. Product pollution risk (high, medium, low)
 Sub Element 1.2 :
Premise and Space/Room

❑ Different zones should be separated with physical

barrier

❑ Zoning :
i. High risk ~ cake decoration room, filling area
ii. Medium risk ~ processing room, preparation
room
iii. Low risk ~ Product store, cartoning room
 Sub Element 1.2 :
Premise and Space/Room
Internal structure of a premise

❑ Material of glass and wood should be avoided

❑ Material chosen should be suitable with
processing condition
❑ Construction material should be maintained and
cleaned easily
❑ Non-hazardous and does not react with
products
 Sub Element 1.2 :
Premise and Space/Room
Flooring

❑ Easy to clean and not slippery

❑ Coved juncture between floors and walls -
prevents accumulation of dirt
❑ Does not collect dust
❑ Good chemical resistant
❑ Should be constructed with some gradients to
prevent water ponding
Sub Element 1.2 :
Premise and Space/Room
GMP factory floor types
❑ Cement (smooth without cracks), “Floor
hardener”, “Homogenous tiles”,
‘Polyurethane”, PVC, Epoxy, Densitop etc
 Sub Element 1.2 :
Premise and Space/Room
Walls
❑ “Flexibility”
❑ Type and size of equipment
❑ Processing condition :
✔ Hot area - concrete wall covered with tiles
✔ Cold room/ freezer/ chiller - PU panel
✔ Wet area - PU Panel, concrete wall covered
with tiles
✔ Dry area “Boral Plaster Board”, PU panel,
concrete wall with epoxy paint, tiles etc.
Sub Element 1.2 :
Premise and Space/Room
Walls

❑ Factory original Concrete Wall with 6 ft

construction Height Tiles
❑ Clean and easy to wash
❑ Reasonable price

Concrete Wall with Epoxy

Paint
 Sub Element 1.2 :
Premise and Space/Room
Ceilings
❑ Processing conditions
Boral Plasterboard
✔ Wet
✔ Hot
✔ Cold

❑ Temperature requirements Polyurethane

❑ Original height of factory
✔ Limited height, suitable to use PU
piece
Aluminium Ceiling
for Hot Area
DHH 3053 Halal Certification & QM : GMP
 Sub Element 1.2 :
Premise and Space/Room
Doors
❑ BOMBA requirements (“Fire
rated door”)
❑ Practicality (sliding door)
❑ Transportation method (“Roller
shutter” and large sized door for
“fork lift” entry)
❑ Processing method (PVC
/PU/”stainless steel” for wet area) Example of PU Door
 Sub Element 1.2 :
Premise and Space/Room
Windows and Viewing Panel

❑ Lighting requirements
❑ Depends on ventilation needs
❑ Emphasizes on illusion of spacious area
 Sub Element 1.3 :
Equipment - Design
❖ Hygienic design
❖ Equipment in contact with food must be
constructed with suitable material
✔ Inert and non-hazardous
✔ Easy cleaning
✔ Doesn’t react with cleaning and sanitation
agent
✔ Non-corrosive
 Sub Element 1.3 :
Equipment - Design

❖ Equipment chosen according to suitability of

processing condition
❖ Type of equipment:
i. Automatic
ii. Semi automatic
iii. Manual
❖ Equipment dimension and parameter must be
well proportionate with the size and space of the
room/area
Sub Element 1.3 :
Equipment - Design
 Sub Element 1.3 :
Equipment – Fixing and Arrangement

❖ Equipment arranged at least 15 cm off the

wall and 20cm off the floor (except plastic
pallet 15 cm off the floor)

❖ Equipment arrangement
✔ Not to be placed under air outlet
✔ Suitable location with suitable lighting
 Sub Element 1.3 :
Equipment
Food Control and Monitoring Equipment

❖ Food control and monitoring equipment need to be

calibrated and verified at appropriate intervals
❖ Should be calibrated according to appropriate
standards
❖ If there’s no existing standards, the basis of
calibration and verification needs to be recorded
❖ E.g : Thermometers and stop watches should be
tested for accuracy
 Sub Element 1.4 :
Facilities
Water Supply

❖ Available supply of potable water should be

equipped with :
✔ Storage facilities
✔ Distribution facilities
✔ Temperature control if necessary
❖ Usage for processing and cleaning of surfaces in
contact with food
❖ Also used for rinsing of packaging materials (ex:
bottles
Sub Element 1.4 :
Facilities
Water Filters

❖ To remove pathogens
❖ To remove chemicals such as chlorines
and carbon
❖ Product quality
 Sub Element 1.4 :
Facilities
Drainage and Waste Disposal

❖ Type of drainage in food industry

i. “Floor trap”
ii. “Scupper drain”

❖ Waste Disposal Facilities Scupper Drain

i. Rubbish bin with lid
ii. Waste assembling area/point
iii. Grease trap
 Sub Element 1.4 :
Facilities
Personnel Hygiene Facilities

❖ Basic needs for hygiene and sanitation of equipment,

utensils and staffs should be provided
❖ Hand wash stations and toilets should be provided
sufficiently
✔ 10 staffs~1 hand washing sink/toilet

❖ Utensils washing sink and multi-purpose sink should be

separated from hand wash station
❖ Physical barrier needs to be built if toilets are attached to
processing area
 Sub Element 1.4 :
Facilities
Personnel Hygiene
Facilities

❖ Toilet and sink need to be

equipped with the followings:
✔ Hands-free water tap
✔ Soap dispenser (with press
button)
✔ Suitable disposable towel or
drying devices
✔ Rubbish bin with lid
 Sub Element 1.4 :
Facilities
Personnel Hygiene Facilities

❖ Provide space/ area for storage of cleaning utensils

❖ Hand dryers and floor dryers need regular maintenance
❖ Changing rooms for staffs :

✔ Ample space
✔ Must be completed with facilities such as:
i. Shower
ii. Locker
iii. Shoes rack
DHH 3053 Halal Certification & QM : GMP
 Sub Element 1.4 :
Facilities
Temperature Control

❖ Depends on products produced

❖ Processes involving temperature control
✔ Heating
✔ Chilling/cooling
✔ Rapid cooling
✔ Thawing
✔ Cold Storage
✔ Frozen Storage
 Sub Element 1.4 :
Facilities

Air Quality and Ventilation

❖ Ventilation is important to control the

accumulation of heat, steam, dirt, smoke and
odour
❖ Poor ventilation can lead to pollution:
✔ Air conditioners comes with air filtering system
✔ Air cooling system also need to comprise with
air filters
✔ Air suction should have concealed net
✔ Air outlet should be closed with net
 Sub Element 1.4 :
Facilities
Lighting

❖ Natural and artificial lighting

❖ Brightness depending on operation, minimal 215
lux from distance of 90 cm from floor
❖ Lights should have plastic covers
❖ Plastic covers should be cleaned periodically
❖ Brightness measured with “lux meter”
 Sub Element 1.4 :
Facilities
Storage

❖ Storage facilities provided according to types of products:

✔ Raw Materials
✔ Packaging Materials
✔ Food Chemicals and Non-food Chemicals
❖ Designed in order to:
✔ Permit adequate maintenance and cleaning
✔ Avoid pest access and harbourage
✔ Enable food to be effectively protected from
contamination during storage
✔ Provide an environment which minimises the
deterioration of food
 Sub Element 1.4 :
Facilities

Storage

Stores need to have:

❖ Rack system using iron/ rust free stainless steel
racks
❖ Plastic pellets. Wood pellets are not suitable for
food factory :
✔ Need to be fumed
✔ Vector for pest
✔ Easily decay
❖ Iron container / Plastic container with lid
❖ All facilities in storage area need to be labeled
accordingly
Element 2 :
Control of Operation
i. Control of Food Hazards
ii. Main aspects in processing control
system
❑ Time and temperature control
❑ Control of specific process steps
❑ Microbiological and other specifications
❑ Control of microbiological, chemical and
physical cross contamination
❑ Non-conformity product control
Element 2 :
Control of Operation
ii. Main aspects in processing control
system (continue)
❑ Raw Material Requirements
❑ Packaging
❑ Water Quality
❑ Management and Monitoring
❑ Documentation and Records Control
❑ Traceability
❑ Product Recall Procedures
Element 2 :
Control of Operation
Main aspects need to be controlled during processing are :
i. Processing time and temperature control
ii. Control of other parameters essential to food safety:
✔ Amount of preservative
✔ Pressure
✔ Type and size of filter
✔ Velocity
✔ Filter replacement schedule
✔ Sensitivity of metal detector
Element 2 :
Control of Operation

Raw materials and food additives should have:

❖ Written specification
❖ Certificates from suppliers
✔ CoA (certificate of analysis)
✔ CoC (certificate of conformance)
❖ Quality and Safety Guarantee Cert. from
suppliers (GMP, HACCP, Halal Certificate)
❖ Guarantee letter
Element 2 :
Control of Operation

Consistent monitoring on processing temperature

to control the quality and safety of products
Element 2 :
Control of Operation

❖ Received raw materials and additives should

comply to specifications fixed by the buyer
❖ If it doesn’t comply, raw materials and additives
need to be returned to suppliers
❖ Continuous monitoring on supplier performance
❖ If there’s no COA from suppliers,(eg: COA for
water quality), analysis should be carried out as
precautions
❖ Food chemical should come with Material
Safety Data Sheet (MSDS)
Element 2 :
Control of Operation

❖ Receiving and Storage of Raw

Material/Chemicals and Packaging
Material done at the provided area
❖ Assigned staff should have full authority
to accept or not accepting raw materials
according to assessment done upon
❖ Receiving stocks should be recorded
Element 2 :
Control of Operation
Important information on the receiving form:
❖ Supplier information
❖ Raw Material Specifications
❖ Purchase quantity
❖ Space to record monitoring result upon receiving:
✔ COA presence
✔ Packaging condition
✔ Cleanliness of distribution transport
✔ Staff hygiene
✔ Distribution transport temperature (For food that
needs temperature control)
Element 2 :
Control of Operation
❖ Raw material need to be received and handled
with care to reduce damage/spoilage
❖ Products received should be quarantined before
being stored
❖ Raw material stored according to suitability and
nature of product (Cold storage/ Chiller/ Dry
storage/ Wet storage)
❖ Should have storage temperature record for cold
room and chiller
❖ “first in first out”- FIFO
Element 2 :
Control of Operation
❖ Stocks record needed for monitoring and stocks
record
❖ Continuous monitoring on expiry dates
❖ Stored raw materials should be labeled and kept in
closed container
❖ Raw materials stored at least 15 cm from the wall
(including those on pellets)
❖ Racks should be arranged at least 20 cm from wall
❖ Enabling easy washing/ cleaning and allows ease of
pest monitoring
 Element 2 :
Control of Operation
Main Aspect in Processing Control System

❖ All equipments should be calibrated and

maintained periodically
❖ Controls needed to prevent cross contamination
❖ Should effectively control physical, chemical and
microbiological
❖ High risk processing (filling process) should be
done in closed and controlled condition
 Element 2 :
Control of Operation
Main Aspect in Processing Control System

❖ Processing done according to SOP

❖ QC aspect at every stage/step of
processing need to be carried out and
recorded
❖ NC products should be managed properly to
avoid confusion
 Element 2 :
Control of Operation
❖ As a step for verification on safety, finished
product sampling is needed
❖ Before sampling done, products are
quarantined
❖ After passing the assessment, products can
be stored in finished product store
❖ NC products need to be separated.
Disposal procedures should be established
Element 2 :
Control of Operation
❖ Test conducted depends on type of
products.
❖ Some of the test carried out:
✔ Visual checking

✔ Test for leakage

✔ Camera detector

✔ Metal detectors

✔ Impurities detector via x-ray

✔ Colour separator

✔ Weighing equipments
 Element 2 :
Control of Operation
Supplier Control

❖ Approved suppliers
❖ Agree with the terms stated in the agreement
✔ CoA/CoC/Guarantee letter
✔ Quality and Safety System In Place (GMP,
HACCP, ISO 22000, Halal)
✔ Supply in adequate quantity

❖ Supplier are audited at proper intervals

 Element 2 :
Control of Operation
Packaging

❖ Packaged products should be stored according to proper

condition (temperature, humidity, lighting or brightness etc)
❖ Packaged products should have:
✔ Label that obeys regulations

✔ Product information

✔ Nutritional information

✔ Batch number

✔ Expiry date
 Element 2 :
Control of Operation
❖ Packaging materials suitable for product and processing condition
(HDPE, LDPE, PP, PET…)
❖ Made of non-hazardous materials and doesn’t react with products
❖ Comply with regulations, can be used for long term, easy cleaning and
sanitized
❖ Category for packaging materials: Primary, Secondary and Tertiary
❖ Filling and packaging should be completely controlled. Normally done
in a special room/area to reduce the risk of pollution.
❖ Visual checking needed, cleaned using filtered water or sprayed with
filtered air before materials being used
 Element 2 :
Control of Operation
Products Recall
An action to recall products from the market (sales,
distribution and usage) due to some doubt of the safety risk
which can effect the health status of consumers

Why ? Complaint from:

✔ Supplier
✔ Retailer/ Shop Owner/businessman
✔ Consumer
✔ Order from the government agency
 Element 2 :
Control of Operation
Products Recall
An action to recall products from the market (sales,
distribution and usage) due to some doubt of the safety risk
which can effect the health status of consumers

Why ? Complaint from:

✔ Supplier
✔ Retailer/ Shop Owner/businessman
✔ Consumer
✔ Order from the government agency
Element 3 :
Maintenance and Sanitation

i. Maintenance and Cleaning

ii. Pest Control Systems

iii. Waste Management Control

 Sub Element 3.1 :
Maintenance and Cleaning
❖ Building, equipment and facilities need to be
maintained in a proper manner periodically.
❖ If there’s changes in structure, improvement,
renovation and piping works need to be carried out
immediately without any delay
❖ Maintenance work should be done without
polluting the product.
❖ Each equipment should have planned
preventative maintenance (PPM)
Sub Element 3.1 :
Maintenance and Cleaning
Definition

Cleaning
The removal of soil, food residue, dirt, grease or other
objectionable matter

Sanitation/ Disinfection
The reduction, by means of chemical agents and/or physical
methods, of the number of microorganisms in the
environment, to a level that does not compromise
food safety or suitability
 Sub Element 3.1 :
Maintenance and Cleaning
Why cleaning and sanitation is important?
❖ Regulation requirements for all food handlers
❖ To reduce the risk of physical, chemical and
microbiological hazards
❖ Reduces the risk of pollution to the products
❖ Prevents pest infestation
❖ Increases shelf life of premise and equipment
 Sub Element 3.2:
Pest Control

i. Types of pest (LILATI)

ii. Why need to be controlled?

iii. How to control pest?

iv. New method of pest control

 Sub Element 3.2:
Pest Control

Control Method :

P = Prevention (e.g fence, closed drainage)

E = Elimination (e.g chemical, trap)
S = Surveillance
T = Treatment (e.g chemical agent)
Sub Element 3.2:
Pest Control

Tempered Resistant
Bait Station ( TRBS )
Electric insect
Insect Light killer
Trap System
 Sub Element 3.3:
Waste Management
❖ Types of waste
❖ Food waste
❖ Non-food waste
❖ Waste should be disposed according to schedule
or before the rubbish bin gets full
❖ Grease trap should be used before liquid waste is
discharged out of the premise
❖ Adequate rubbish bin with lid
❖ Waste receptacles and waste accumulating area
outside of the premise should be kept
appropriately clean and disinfected periodically
 Sub Element 3.3:
Waste Management
Sewage waste

❖ Liquid waste need to be treated before drained

outside of the factory
❖ Ensure that this waste does not pollute raw
materials, finished products, or drinking water
❖ Piping line and liquid waste drainage system
should be adequate
❖ Blocked drainage system need to be cleaned
very often to prevent pollution
Element 4 :
Workers
i. Health status

ii. Illness and Injuries

iii. Personal cleanliness

iv. Personal behavior

v. Visitors
Sub Element 4.1 :
Health Status
Personnel Health

❖ Routine medical check-ups (records)

❖ Any personnel whom confirmed to disease that can
affect the quality of food, are not allowed in the food
processing area
❖ Management should provide medical facilities (first aid
kit) for the staff
❖ Any health related complications need to be reported
including: Diarrhea, Fever, Jaundice, Skin infections
(that is visible), Infections on eyes , ears and nose
Sub Element 4.3 :
Personal Cleanliness
Features of
protective clothing:
❖ Easily cleaned
❖ Long Lasting
❖ Does not
pollute
❖ Bright colours
❖ Without
buttons
Sub Element 4.3 :
Personal Cleanliness

Latex Disposable
Gloves
Hair Cap

Vinyl Disposable
Hand Gloves
Beard Cover

Nitril disposable
hand gloves Protective
clothing
Sub Element 4.3 :
Personal Cleanliness
Personnel hygiene practices:
i. Proper protective clothing
ii. Wash hands after :
❖ Using the toilet
❖ Touching the face, nose, mouth
and ears
❖ Handling Raw Materials
❖ Handling Waste
❖ Cleaning
❖ Out from working area
Sub Element 4.3 :
Personal Cleanliness
Personnel hygiene practices (continue) :
iii. Hand gloves are worn during handling of
food
iv. No jewelleries allowed (physical hazard)
v. Personal clothes and things are kept in a
special allocated area
vi. No eating, chewing gums, smoking in the
processing area
vii. Tie hair and wear hair cap/cover
viii. Clean nails and no nail polishes
 Element 5 :
Transportation and Distribution
❖ Food producers need to provide
appropriate transportation for finished
products distributions
❖ Type of transports depend on type of
products:
✔ Frozen
✔ Chilled
✔ Light sensitive products
❖ Products that require temperature
control should be distributed in a
suitable transportation
Element 5 :
Transportation and Distribution
❖ Conveyances and containers for transporting food
should be kept in an appropriate state of cleanliness,
repair and condition
❖ Can be effectively cleaned and where necessary,
disinfected
❖ Provide effective protection from pest infestation and
other contamination, including dust and fumes
❖ Permit effective separation of different foods or foods
from non-food items where necessary during transport
❖ Allow any necessary temperature, humidity and other
conditions to be checked
Element 6 :
Traceability
i. Lot Identification and Batch Number

ii. Product Information

iii. Food Labeling

 Sub Element 6.2 :
Product Information

❖ Batch Number Identification

✔ Permanent markings on the food
label
❖ Product Information
❖ Comply to Food Labeling
Regulations
✔ Including allergens
 Element 7:
Internal Audit

❖ Self Evaluation
❖ Internal audit
✔ At least once a year
✔ including supplier audit
✔ Proper action taken for CAR being
established
✔ Audit report established and
documented
✔ Company’s own staff or external
consultant for internal audit
 Element 7:
Internal Audit

❖ Self Evaluation
❖ Internal audit
✔ At least once a year
✔ including supplier audit
✔ Proper action taken for CAR being
established
✔ Audit report established and
documented
✔ Company’s own staff or external
consultant for internal audit
Element 8 :
Training

i. Awareness and Responsibilities

ii. Training Programmes

 Element 8 :
Training
❖ Companies shall prepare a training plan
and training programme should be
routinely reviewed and updated where
necessary
❖ Training record shall be maintained
❖ Internal Courses or Open Courses
❖ All personnel should have training records
❖ Periodic assessments of the effectiveness
of training should be made
 Element 8 :
Training
❖ All food handlers should attend Food Handlers
Training (conducted by approved Food
Handlers Training School)
❖ Other courses:
▪ Induction course for new personnel
▪ GMP courses
▪ HACCP courses
▪ Halal courses
▪ Technical courses related to job scope

✔ Cleaning method / procedures

✔ Equipment operations
Commonly Detected Non Conformance During
Food Premises Inspection

1. Storage of high risk food such as poultry, meat

and seafood at incorrect temperature (frozen
food: ≤ -18ºC and chilled food ≤ 4ºC)
2. Ready to eat food placed to long at ambient
temperature before serving (contribute to 60% of
food poisoning cases-Olsen et al. 2001)
3. Improper kitchen setup and inadequate working
space
4. 100% school canteen, 75% restaurant and
50%food factory without proper hand washing
facilities (contribute to 31% of food poisoning
cases-Olsen et al. 2001)
Commonly Detected Non Conformance During
Food Premises Inspection

5. 75% of food premises don't carry out any

pest control activities to control pest
6. Food handlers without basic food hygiene
training and vaccination
7. Without any procedures or records for
cleaning, storage temperature, training,
maintenance
8. Infrastructural defect and poor maintenance
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