Transcript 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.

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
According to FDA, the SSOP should include:
* 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
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.
CLEANING, MAINTENANCE AND
PERSONNEL HYGIENE
Appropriate facilities and cleaning
procedures
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
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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
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current written composition
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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
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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:
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adequate source
appropriate temperature and
pressure
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separated system according to use
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allowed disinfecting agents
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control of drinking water
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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
Cleaning effectiveness will depend
upon several basic factors:
• Contact time
• Temperature
• Physical disruption of the soil
(scrubbing)
• Water chemistry
SANITATION AGENTS
• Chlorine
• Quaternary Ammonium Compounds
• Iodophors,
• Acid sanitizers including acidanionium,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
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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
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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