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

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;
manufacturers, packers and/or distributors
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
have enough knowledge of
of food hygiene

should
principles

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 clean ing,
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
cleaned
- responsibility for specific tasks
- method and frequency of cleaning
- monitoring

to be

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 facilitys 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