PART II
GOOD MANUFACTURING
PRACTICES (GMP)
GMP
Prerequisite programs which will provide
the basic environmental and operating
conditions that are necessary for the
production of safe and wholesome food,
SSOP
Sanitation Standard
Operating Procedures
* General maintenance
* Substances used in cleaning and sanitizing;
* storage of toxic materials
* Pest control,
* Sanitation of food-contact surfaces
* Storage and handling of clean portable
equipment and utensils
* Rubbish disposal
According to FDA,the SSOP should include:
The SSOP adopted by FSIS cover the
pre-operational and operational
sanitation procedures that an
establishment shall implement to
prevent direct contamination or
adulteration of products
FOOD SAFETY ON
PRIMARY
PRODUCTION
DEFINITION
Covers all steps of the food chain,
from production to harvest,
slaughter,milking or fishery
OBJECTIVE
Ensures that food is safe and
suitable for its intended use
CHALLENGE
The integration of government agencies
with primary producers.
IMPORTANT ASPECTS
ENVIRONMENTAL HYGIENE
–Water
–Land
HYGIENIC PRODUCTION OF FOOD
HANDLING,STORAGE AND
TRANSPORTATION
CLEANING,MAINTENANCE AND
PERSONNEL HYGIENE
ENVIRONMENTAL HYGIENE
– Water,irrigation,application of pesticides
and fertilizers,cooling,frost control,drinking
water,cleaning of buildings,personal
hygiene,etc
– Has the potential to be a direct source of
contamination and a vehicle for spreading
contamination
– Irrigation water source and supply
HYGIENIC PRODUCTION OF FOOD
Control contamination from air,soil,water,
foodstuffs,fertilizers (including natural
fertilizers),pesticides,veterinary drugs or any
other agent used in primary production;
Control plant and animal health so that it does
not pose a threat to human health through food
consumption,or adversely affect the suitability
of the product;
Protect food from fecal and other
contamination;
Manage wastes,and store harmful
substances appropriately,
HANDLING,STORAGE AND
TRANSPORTATION
Procedures should be in place to:
- Sort out food and food ingredients from
material which is clearly unfit for human
consumption;
- Dispose of any rejected material in a hygienic
manner; and;
- Protect food and food ingredients from
contamination by pests,chemical,physical or
microbial contaminants or other objectionable
substances during handling,storage and
transportation.
Appropriate facilities and cleaning
procedures
CLEANING,MAINTENANCE AND
PERSONNEL HYGIENE
ESTABLISHMENT,DESIGN
AND FACILITIES
OBJECTIVES
- Minimize contamination;
- Permit appropriate maintenance,
cleaning and sanitizing
BUILDING
Establishments should be built away from
Polluted areas and industrial activities
which pose a threat for contamination of food;
Areas subject to floods,unless sufficient
safeguards are provided;
areas prone to infestations by pests;
Areas where waste (solid or liquid) cannot be
removed effectively.
MAINTENANCE
– Maintain roads,yards,and parking to avoid
contamination of areas where food is exposed;
– Adequately drain areas that may
contribute to contamination of food by
foodborne filth,or provide conditions for
nesting and breeding of for pests;
– Operate systems for waste treatment and
disposal in an adequate manner.
PREMISES AND WORKING AREAS
Design and layout
- protect against cross-contamination
- control process flow
Internal structures and fittings
Walls and floors;
Ceilings and overhead fixtures;
Windows;
Doors;
Working surfaces;
Establishments;
Sewage lines,
EQUIPMENT
Sanitation and maintenance to avoid
contamination:
– Construction material
– Durability
– Maintenance,Sanitation,Monitoring
Program of preventive maintenance
- List of equipment requiring regular
maintenance.
- Procedures and frequencies of maintenance
are based on instructions from the
manufacturers or on operating conditions.
FACILITIES
Water supply
Drainage and waste disposal
Cleaning
Facilities for personnel hygiene
Toilets
Temperature control
Air quality and ventilation
Lighting
Storage
CONTROL OF
OPERATIONS
Objectives
Production of safe and suitable food for
human consumption ensuring:
requirements for raw materials,
composition,processing,distribution,
and consumer use;
designing,implementing,monitoring
and reviewing control systems,
Control of Food
Hazards
identify any points in the operations
which are critical to the safety of food;
implement effective control
procedures;
ensure effectiveness of procedures;
review procedures periodically.
Examples of general procedures
Product composition
current written composition
details of formulation
Food additives
Manufacturer should guarantee that all
additives in use:
are approved for the food being
produced;
comply with the specific laws and
regulations;
are pure;
provide certifications for each lot
comply with legal limits.
Label accuracy
The manufacturer should ensure that the label
provides:
accurate information of net contents;
manufacturer’s,packer’s and/or distributor’s
names and addresses; and
instructions for proper handling by the
consumer
Time and temperature
control
Time and temperature
control
Such controls include time and
temperature of,
Cooking
Cooling
Processing
Storage
Temperature control systems
should take into account:
nature of the food
intended shelf-life of the product
method of packaging and processing
intended use
Specify limits for time and temperature
variation
Calibration and verification of
equipment and instruments
Metrologic verification
Set of operations needed to assure that a
measuring equipment complies with
standards and requirements for the
intended use.
Specific process steps
chilling
thermal processing
irradiation
drying
chemical preservation
packaging in vacuum or modified
atmospheer
Microbiological cross
contamination
Pathogens can be transferred from
one food to another,either by direct
contact,by food handlers,through
common contact with surfaces,or
through the air.
Chemical and physical
contamination
Contamination of food by foreign
matters such as glass or metal
particles,dust,harmful fumes and
unwanted chemicals.
RAW MATERIAL AND
INGREDIENTS
Reception:
– Manufacturer
– Specifications
– Chemicals
– Inspection of raw material
PACKAGING
Packaging materials
Protection of food
Prevent recontamination
WATER
Water Quality
Chlorine
Analysis
Cleaning of reservoirs
Ice making
Steam production
Drainage
Plumbing
Aspects to be considered:
adequate source
appropriate temperature and
pressure
separated system according to use
allowed disinfecting agents
control of drinking water
Monitoring
Correcting deviations
Records
Water standards,WHO
MANAGEMENT AND
SUPERVISION
The type of control and supervision
needed will depend on the size of
the business,the nature of the
activities and the types of food being
produced,
Managers and supervisors should
have enough knowledge of principles
of food hygiene
DOCUMENTATION AND
RECORDS
Monitoring time
Legibility
Revising and updating records
RECALL PROCEDURES
Recall information should include the
following:
- Amount of product produced,in inventory
and distributed.
- Name,size,code or lot numbers of food
recalled
- Area of distribution
- Reason for the recall
- Final disposition of the product (rework,
discharge,etc.)
Storage
Temperature conditions
Relative humidity
Air velocity
FIFO (First In First Out)
BUILDING
MAINTENANCE AND
SANITATION
OBJECTIVES
To establish effective systems to ensure
appropriate maintenance and cleaning,
pest control,waste management and
effective monitoring.
Biofilm:
Adhesion
Protection
Resistance
CLEANING PROCEDURES
AND METHODS
Cleaning and sanitizing normally
require the following steps:
1,Dry clean
2,Pre-rinse
3,Detergent application (may include
scrubbing)
4,Post-rinse; and
5,Sanitizer application.
CLEANING PROGRAMS
Where written cleaning programs
are used,they should specify:
- areas,items of equipment and utensils
to be cleaned
- responsibility for specific tasks
- method and frequency of cleaning
- monitoring
CLEANING OF EQUIPMENT
CIP (clean-in-place),
manual
automatic
immersion
drying
CLEANING OF PREMISES
areas to be cleaned;
methods of cleaning;
person responsible; and
frequency of the activity
DETERGENTS
General use
Alkaline or chlorinated detergents
Acid detergents
Enzymatic detergents
Contact time
Temperature
Physical disruption of the soil
(scrubbing)
Water chemistry
Cleaning effectiveness will depend
upon several basic factors,
SANITATION AGENTS
Chlorine
Quaternary Ammonium Compounds
Iodophors,
Acid sanitizers including acid-
anionium,carboxylic and peroxyacetic acid
types
Ozone
Ultraviolet(UV) irradiation
Hot (hot water)
PEST CONTROL
Preventing access
Entrance sites
External and Internal inspection
Assess the facility’s capacity for
excluding pests.
Harborage and
infestation
Availability of food and water
Effectiveness of cleaning and
sanitation procedures
Monitoring and
detection
Observations of the presence
Evidence of the presence
Eradication
Agents:
Chemical
Physical
Biological
Waste Management
Storage Areas
Waste bins,tubs and dumpsters
Proper cleaning and sanitizing
SANITATION
MONITORING
EFFECTIVENESS
Sanitation systems program
periodically verified
– Audit pre-operational inspections,
– Microbiological sampling of environment
and food contact.
PERSONAL
HYGIENE
Objective
To ensure that those who come directly or
indirectly into contact with food are not
likely to contaminate it.
HEALTH STATUS
Illness
Injuries
Individual Health Card
PERSONAL
CLEANLINESS
Personal effects
Hand washing
Use of antiseptic on hands
UNIFORM
Uniform
– Uniforms should be kept clean and in
good condition.
Masks and gloves
– should be used when a ready-to-eat
food is prepared
PERSONAL
BEHAVIOR
Trained to be conscious of the
importance of GMP
Unacceptable Action
VISITORS
Adhere to the same personal
hygienic provisions described for
food handlers,
TRANSPORTATION
OBJECTIVES
To protect food from potential sources of
contamination and from damage likely to render
food unsuitable for consumption;
To provide an environment which limits growth
of pathogenic or spoilage microorganisms and
the production of toxins.
Requirements
design and construction
clean and/or disinfect
separate foods from non-food items
maintain temperature
verification of temperature
prevent contamination
VERIFICATION
- Inspection of vehicle
- Program describing effective cleaning and
sanitation procedures
- Restrain transportation of non-food items
- Loading/unloading
- Design and construction of tank vehicles
- Materials used in vehicles for food transportation
PRODUCT INFORMATION
AND CONSUMER
AWARENESS
OBJECTIVES
– All products should be labeled with sufficient
information to ensure that the person in the next
step of the food chain will understand how to
handle,store,process,prepare and display the
product safely and correctly ;
– This information should contain a clear
identification of the lot or batch in order to
facilitate any necessary recall.
Lot identification
A lot is a defined quantity of a commodity
produced under the same conditions.
Lot identification is essential to product
recall and also contributes to effective
stock rotation,
Product information
Adequate label information on food
products enables the next person in the
food chain to handle,display,store,
prepare and use the product safely and
correctly.
Labeling
“Codex of General Standard for the
Labeling of Prepackaged Foods”
(CODEX STAN 1-1985),
The minimum information required on
prepackaged labels is,
Name of the food
Ingredients
Net contents and drained weight
Name and address of manufacturer,
packager,distributor,importer,exporter
or vendor of the food
Country of origin;
Lot identification;
Date and storage instructions;
Instructions for use.
Consumer
education
Health education programs should cover
general food hygiene;
Helping consumers to understand the
importance of reading labels,following
instructions for use,and making correct
choices;
Information on the relationship between
time/temperature control and foodborne
diseases
TRAINING
Awareness and responsibilities
Training programs
Instruction and supervision
Refreshing training
Minimum program for GMP training courses
Code of Hygyenic Practices - Codex
Alimentarius Commission
Minimum program for
GMP training courses
Primary production;
Design of plant and facilities
Control of operations;
Plant maintenance and sanitation;
Transportation;
Product information and consumer
awareness;
Training;
GMP evaluation.
GOOD MANUFACTURING
PRACTICE EVALUATION
Verification
Audit
GOOD MANUFACTURING
PRACTICES (GMP)
GMP
Prerequisite programs which will provide
the basic environmental and operating
conditions that are necessary for the
production of safe and wholesome food,
SSOP
Sanitation Standard
Operating Procedures
* General maintenance
* Substances used in cleaning and sanitizing;
* storage of toxic materials
* Pest control,
* Sanitation of food-contact surfaces
* Storage and handling of clean portable
equipment and utensils
* Rubbish disposal
According to FDA,the SSOP should include:
The SSOP adopted by FSIS cover the
pre-operational and operational
sanitation procedures that an
establishment shall implement to
prevent direct contamination or
adulteration of products
FOOD SAFETY ON
PRIMARY
PRODUCTION
DEFINITION
Covers all steps of the food chain,
from production to harvest,
slaughter,milking or fishery
OBJECTIVE
Ensures that food is safe and
suitable for its intended use
CHALLENGE
The integration of government agencies
with primary producers.
IMPORTANT ASPECTS
ENVIRONMENTAL HYGIENE
–Water
–Land
HYGIENIC PRODUCTION OF FOOD
HANDLING,STORAGE AND
TRANSPORTATION
CLEANING,MAINTENANCE AND
PERSONNEL HYGIENE
ENVIRONMENTAL HYGIENE
– Water,irrigation,application of pesticides
and fertilizers,cooling,frost control,drinking
water,cleaning of buildings,personal
hygiene,etc
– Has the potential to be a direct source of
contamination and a vehicle for spreading
contamination
– Irrigation water source and supply
HYGIENIC PRODUCTION OF FOOD
Control contamination from air,soil,water,
foodstuffs,fertilizers (including natural
fertilizers),pesticides,veterinary drugs or any
other agent used in primary production;
Control plant and animal health so that it does
not pose a threat to human health through food
consumption,or adversely affect the suitability
of the product;
Protect food from fecal and other
contamination;
Manage wastes,and store harmful
substances appropriately,
HANDLING,STORAGE AND
TRANSPORTATION
Procedures should be in place to:
- Sort out food and food ingredients from
material which is clearly unfit for human
consumption;
- Dispose of any rejected material in a hygienic
manner; and;
- Protect food and food ingredients from
contamination by pests,chemical,physical or
microbial contaminants or other objectionable
substances during handling,storage and
transportation.
Appropriate facilities and cleaning
procedures
CLEANING,MAINTENANCE AND
PERSONNEL HYGIENE
ESTABLISHMENT,DESIGN
AND FACILITIES
OBJECTIVES
- Minimize contamination;
- Permit appropriate maintenance,
cleaning and sanitizing
BUILDING
Establishments should be built away from
Polluted areas and industrial activities
which pose a threat for contamination of food;
Areas subject to floods,unless sufficient
safeguards are provided;
areas prone to infestations by pests;
Areas where waste (solid or liquid) cannot be
removed effectively.
MAINTENANCE
– Maintain roads,yards,and parking to avoid
contamination of areas where food is exposed;
– Adequately drain areas that may
contribute to contamination of food by
foodborne filth,or provide conditions for
nesting and breeding of for pests;
– Operate systems for waste treatment and
disposal in an adequate manner.
PREMISES AND WORKING AREAS
Design and layout
- protect against cross-contamination
- control process flow
Internal structures and fittings
Walls and floors;
Ceilings and overhead fixtures;
Windows;
Doors;
Working surfaces;
Establishments;
Sewage lines,
EQUIPMENT
Sanitation and maintenance to avoid
contamination:
– Construction material
– Durability
– Maintenance,Sanitation,Monitoring
Program of preventive maintenance
- List of equipment requiring regular
maintenance.
- Procedures and frequencies of maintenance
are based on instructions from the
manufacturers or on operating conditions.
FACILITIES
Water supply
Drainage and waste disposal
Cleaning
Facilities for personnel hygiene
Toilets
Temperature control
Air quality and ventilation
Lighting
Storage
CONTROL OF
OPERATIONS
Objectives
Production of safe and suitable food for
human consumption ensuring:
requirements for raw materials,
composition,processing,distribution,
and consumer use;
designing,implementing,monitoring
and reviewing control systems,
Control of Food
Hazards
identify any points in the operations
which are critical to the safety of food;
implement effective control
procedures;
ensure effectiveness of procedures;
review procedures periodically.
Examples of general procedures
Product composition
current written composition
details of formulation
Food additives
Manufacturer should guarantee that all
additives in use:
are approved for the food being
produced;
comply with the specific laws and
regulations;
are pure;
provide certifications for each lot
comply with legal limits.
Label accuracy
The manufacturer should ensure that the label
provides:
accurate information of net contents;
manufacturer’s,packer’s and/or distributor’s
names and addresses; and
instructions for proper handling by the
consumer
Time and temperature
control
Time and temperature
control
Such controls include time and
temperature of,
Cooking
Cooling
Processing
Storage
Temperature control systems
should take into account:
nature of the food
intended shelf-life of the product
method of packaging and processing
intended use
Specify limits for time and temperature
variation
Calibration and verification of
equipment and instruments
Metrologic verification
Set of operations needed to assure that a
measuring equipment complies with
standards and requirements for the
intended use.
Specific process steps
chilling
thermal processing
irradiation
drying
chemical preservation
packaging in vacuum or modified
atmospheer
Microbiological cross
contamination
Pathogens can be transferred from
one food to another,either by direct
contact,by food handlers,through
common contact with surfaces,or
through the air.
Chemical and physical
contamination
Contamination of food by foreign
matters such as glass or metal
particles,dust,harmful fumes and
unwanted chemicals.
RAW MATERIAL AND
INGREDIENTS
Reception:
– Manufacturer
– Specifications
– Chemicals
– Inspection of raw material
PACKAGING
Packaging materials
Protection of food
Prevent recontamination
WATER
Water Quality
Chlorine
Analysis
Cleaning of reservoirs
Ice making
Steam production
Drainage
Plumbing
Aspects to be considered:
adequate source
appropriate temperature and
pressure
separated system according to use
allowed disinfecting agents
control of drinking water
Monitoring
Correcting deviations
Records
Water standards,WHO
MANAGEMENT AND
SUPERVISION
The type of control and supervision
needed will depend on the size of
the business,the nature of the
activities and the types of food being
produced,
Managers and supervisors should
have enough knowledge of principles
of food hygiene
DOCUMENTATION AND
RECORDS
Monitoring time
Legibility
Revising and updating records
RECALL PROCEDURES
Recall information should include the
following:
- Amount of product produced,in inventory
and distributed.
- Name,size,code or lot numbers of food
recalled
- Area of distribution
- Reason for the recall
- Final disposition of the product (rework,
discharge,etc.)
Storage
Temperature conditions
Relative humidity
Air velocity
FIFO (First In First Out)
BUILDING
MAINTENANCE AND
SANITATION
OBJECTIVES
To establish effective systems to ensure
appropriate maintenance and cleaning,
pest control,waste management and
effective monitoring.
Biofilm:
Adhesion
Protection
Resistance
CLEANING PROCEDURES
AND METHODS
Cleaning and sanitizing normally
require the following steps:
1,Dry clean
2,Pre-rinse
3,Detergent application (may include
scrubbing)
4,Post-rinse; and
5,Sanitizer application.
CLEANING PROGRAMS
Where written cleaning programs
are used,they should specify:
- areas,items of equipment and utensils
to be cleaned
- responsibility for specific tasks
- method and frequency of cleaning
- monitoring
CLEANING OF EQUIPMENT
CIP (clean-in-place),
manual
automatic
immersion
drying
CLEANING OF PREMISES
areas to be cleaned;
methods of cleaning;
person responsible; and
frequency of the activity
DETERGENTS
General use
Alkaline or chlorinated detergents
Acid detergents
Enzymatic detergents
Contact time
Temperature
Physical disruption of the soil
(scrubbing)
Water chemistry
Cleaning effectiveness will depend
upon several basic factors,
SANITATION AGENTS
Chlorine
Quaternary Ammonium Compounds
Iodophors,
Acid sanitizers including acid-
anionium,carboxylic and peroxyacetic acid
types
Ozone
Ultraviolet(UV) irradiation
Hot (hot water)
PEST CONTROL
Preventing access
Entrance sites
External and Internal inspection
Assess the facility’s capacity for
excluding pests.
Harborage and
infestation
Availability of food and water
Effectiveness of cleaning and
sanitation procedures
Monitoring and
detection
Observations of the presence
Evidence of the presence
Eradication
Agents:
Chemical
Physical
Biological
Waste Management
Storage Areas
Waste bins,tubs and dumpsters
Proper cleaning and sanitizing
SANITATION
MONITORING
EFFECTIVENESS
Sanitation systems program
periodically verified
– Audit pre-operational inspections,
– Microbiological sampling of environment
and food contact.
PERSONAL
HYGIENE
Objective
To ensure that those who come directly or
indirectly into contact with food are not
likely to contaminate it.
HEALTH STATUS
Illness
Injuries
Individual Health Card
PERSONAL
CLEANLINESS
Personal effects
Hand washing
Use of antiseptic on hands
UNIFORM
Uniform
– Uniforms should be kept clean and in
good condition.
Masks and gloves
– should be used when a ready-to-eat
food is prepared
PERSONAL
BEHAVIOR
Trained to be conscious of the
importance of GMP
Unacceptable Action
VISITORS
Adhere to the same personal
hygienic provisions described for
food handlers,
TRANSPORTATION
OBJECTIVES
To protect food from potential sources of
contamination and from damage likely to render
food unsuitable for consumption;
To provide an environment which limits growth
of pathogenic or spoilage microorganisms and
the production of toxins.
Requirements
design and construction
clean and/or disinfect
separate foods from non-food items
maintain temperature
verification of temperature
prevent contamination
VERIFICATION
- Inspection of vehicle
- Program describing effective cleaning and
sanitation procedures
- Restrain transportation of non-food items
- Loading/unloading
- Design and construction of tank vehicles
- Materials used in vehicles for food transportation
PRODUCT INFORMATION
AND CONSUMER
AWARENESS
OBJECTIVES
– All products should be labeled with sufficient
information to ensure that the person in the next
step of the food chain will understand how to
handle,store,process,prepare and display the
product safely and correctly ;
– This information should contain a clear
identification of the lot or batch in order to
facilitate any necessary recall.
Lot identification
A lot is a defined quantity of a commodity
produced under the same conditions.
Lot identification is essential to product
recall and also contributes to effective
stock rotation,
Product information
Adequate label information on food
products enables the next person in the
food chain to handle,display,store,
prepare and use the product safely and
correctly.
Labeling
“Codex of General Standard for the
Labeling of Prepackaged Foods”
(CODEX STAN 1-1985),
The minimum information required on
prepackaged labels is,
Name of the food
Ingredients
Net contents and drained weight
Name and address of manufacturer,
packager,distributor,importer,exporter
or vendor of the food
Country of origin;
Lot identification;
Date and storage instructions;
Instructions for use.
Consumer
education
Health education programs should cover
general food hygiene;
Helping consumers to understand the
importance of reading labels,following
instructions for use,and making correct
choices;
Information on the relationship between
time/temperature control and foodborne
diseases
TRAINING
Awareness and responsibilities
Training programs
Instruction and supervision
Refreshing training
Minimum program for GMP training courses
Code of Hygyenic Practices - Codex
Alimentarius Commission
Minimum program for
GMP training courses
Primary production;
Design of plant and facilities
Control of operations;
Plant maintenance and sanitation;
Transportation;
Product information and consumer
awareness;
Training;
GMP evaluation.
GOOD MANUFACTURING
PRACTICE EVALUATION
Verification
Audit
