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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 food* Storage and handling of clean portable equipment and utensils * Rubbish disposal

The SSOP adopted by FSIS cover the prepre-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. 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; 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: 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. 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; food; ) Areas subject to floods, unless sufficient safeguards are provided; ) areas prone to infestations by pests; 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 cross- 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: contamination: Construction material Durability Maintenance, Sanitation, Monitoring Monitoring

Program of preventive maintenance preventive


- 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; 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; regulations;

 are pure;  provide certifications for each lot


 comply with legal limits. limits.

Label accuracy
The manufacturer should ensure that the label provides provides: accurate information of net contents; manufacturers, packers and/or distributors names and addresses; and addresses; 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 shelf 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 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, 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 standards:

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, cleaning, pest control, waste management and control, effective monitoring.

Biofilm:
Adhesion Protection Resistance

CLEANING PROCEDURES AND METHODS

Cleaning and sanitizing normally require the following steps: 1. Dry clean 2. Pre-rinse Pre3. Detergent application (may include scrubbing) 4. Post-rinse; and Post5. 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). (clean-in-place). manual automatic immersion drying 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 Enzymatic

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 acidincluding acidanionium,carboxylic 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 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, pre 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 ready-tofood is prepared

PERSONAL BEHAVIOR

Trained to be conscious of the importance of GMP Unacceptable Action

VISITORS

Adhere to the same personal hygienic 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. toxins.

Requirements
design and construction construction clean and/or disinfect separate foods from non-food items nonmaintain temperature verification of temperature prevent contamination

VERIFICATION
- Inspection of vehicle

- Program describing effective cleaning and sanitation procedures - Restrain transportation of non-food items non- Loading/unloading Loading/ - Design and construction of tank vehicles construction - Materials used in vehicles for food transportation 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 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. conditions. Lot identification is essential to product recall and also contributes to effective stock rotation. 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). 1-

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; origin;  Lot identification; identification;  Date and storage instructions; instructions;  Instructions for use. 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 Refreshing 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; maintenance

Transportation; Product information and consumer awareness; Training; Training; GMP evaluation. evaluation.

GOOD MANUFACTURING PRACTICE EVALUATION

Verification Audit

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