PART II GOOD MANUFACTURING PRACTICES (GMP)

GMPPrerequisite 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 disposalAccording 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 HYGIENEWater 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

BUILDINGEstablishments 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-contaminationcontrol 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 supplyDrainage and waste disposalCleaningFacilities for personnel hygieneToiletsTemperature controlAir quality and ventilationLightingStorage

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

chillingthermal processingirradiationdryingchemical 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 materialsProtection of foodPrevent recontamination

WATER

Water Quality ChlorineAnalysisCleaning of reservoirs

Ice makingSteam productionDrainagePlumbing

Aspects to be considered:adequate sourceappropriate temperature and pressureseparated system according to useallowed disinfecting agents control of drinking water

MonitoringCorrecting deviationsRecordsWater 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 conditionsRelative humidityAir velocityFIFO (First In First Out)

BUILDINGMAINTENANCE AND SANITATION

OBJECTIVES

To establish effective systems to ensure appropriate maintenance and cleaning, pest control, waste management and effective monitoring.

Biofilm:

AdhesionProtectionResistance

CLEANING PROCEDURES AND METHODS

Cleaning and sanitizing normally require the following steps:

1. Dry clean2. Pre-rinse 3. Detergent application (may include scrubbing)4. Post-rinse; and5. 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; andfrequency of the activity

DETERGENTS

General useAlkaline or chlorinated detergentsAcid detergents Enzymatic detergents

Cleaning effectiveness will depend upon several basic factors: Contact timeTemperaturePhysical disruption of the soil (scrubbing)Water chemistry

SANITATION AGENTS

ChlorineQuaternary Ammonium CompoundsIodophors, Acid sanitizers including acid-anionium,carboxylic and peroxyacetic acid typesOzoneUltraviolet(UV) irradiationHot (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:

ChemicalPhysicalBiological

Waste Management

Storage AreasWaste bins, tubs and dumpstersProper 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

IllnessInjuriesIndividual Health Card

PERSONAL CLEANLINESS

Personal effects Hand washing Use of antiseptic on hands

UNIFORM

UniformUniforms should be kept clean and in good condition.

Masks and glovesshould be used when a ready-to-eat food is prepared

PERSONALBEHAVIOR

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 constructionclean and/or disinfectseparate foods from non-food itemsmaintain temperatureverification of temperatureprevent 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 forGMP training coursesPrimary production;Design of plant and facilitiesControl of operations;Plant maintenance and sanitation;

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

GOOD MANUFACTURING PRACTICE EVALUATION

Verification Audit