PART IIPART II

GOOD MANUFACTURING GOOD MANUFACTURING

PRACTICES (GMP)PRACTICES (GMP)

GMPGMP

Prerequisite programs which will provide Prerequisite programs which will provide the basic environmental and operating the basic environmental and operating conditions that are necessary for the conditions that are necessary for the production of safe and wholesome food. production of safe and wholesome food.

SSOPSSOP

Sanitation Standard Sanitation Standard

Operating ProceduresOperating Procedures

* * General maintenanceGeneral maintenance

* * Substances used in cleaning and sanitizing; Substances used in cleaning and sanitizing;

* * storage of toxic materialsstorage of toxic materials

* * Pest control: Pest control:

* * Sanitation of food-contact surfacesSanitation of food-contact surfaces

* * Storage and handling of clean portable Storage and handling of clean portable

equipment and utensilsequipment and utensils

* * Rubbish disposalRubbish disposal

According to FDA, the SSOP should include:According to FDA, the SSOP should include:

The SSOP adopted by FSIS cover the The SSOP adopted by FSIS cover the

pre-operational and operational pre-operational and operational

sanitation procedures that sanitation procedures that anan

establishment establishment shallshall implement to implement to

prevent direct contamination or prevent direct contamination or

adulteration of productsadulteration of products

FOOD SAFETY ON

PRIMARY

PRODUCTION

DEFINITIONDEFINITION

CoversCovers all steps of the food all steps of the food

chain, from production to chain, from production to

harvest, slaughter, milking or harvest, slaughter, milking or

fisheryfishery

OBJECTIVEOBJECTIVE

Ensures that food is safe and Ensures that food is safe and

suitable for its intended usesuitable for its intended use

CHALLENGECHALLENGE

The integration of governmentThe integration of government agencies agencies

with primary producerwith primary producerss..

IMPORTANT ASPECTSIMPORTANT ASPECTS

• ENVIRONMENTAL HYGIENEENVIRONMENTAL HYGIENE

–Water Water

–LandLand

• HYGIENIC PRODUCTION OF FOODHYGIENIC PRODUCTION OF FOOD

• HANDLING, STORAGE AND HANDLING, STORAGE AND

TRANSPORTATIONTRANSPORTATION

• CLEANING, MAINTENANCE AND CLEANING, MAINTENANCE AND

PERSONNEL HYGIENEPERSONNEL HYGIENE

ENVIRONMENTAL HYGIENEENVIRONMENTAL HYGIENE

– Water: Water: irrigation, application of pesticides irrigation, application of pesticides and fertilizers, cooling, frost control, drinking and fertilizers, cooling, frost control, drinking water, cleaning of buildings, personal water, cleaning of buildings, personal hygiene, etc hygiene, etc

– Has the potential to be a direct source of Has the potential to be a direct source of contamination and a vehicle for spreading contamination and a vehicle for spreading contaminationcontamination

– Irrigation Irrigation wwater source and supplyater source and supply

HYGIENIC PRODUCTION OF FOODHYGIENIC PRODUCTION OF FOOD

• Control contamination from air, soil, water, Control contamination from air, soil, water,

foodstuffs, fertilizers (including natural foodstuffs, fertilizers (including natural

fertilizers), pesticides, veterinary drugs or any fertilizers), pesticides, veterinary drugs or any

other agent used in primary productionother agent used in primary production; ;

• Control plant and animal health so that it does Control plant and animal health so that it does

not pose a threat to human health through food not pose a threat to human health through food

consumption, or adversely affect the suitability consumption, or adversely affect the suitability

of the product; of the product;

• Protect food from fecal and other Protect food from fecal and other contamination;contamination;

• Manage wastes, and store harmful Manage wastes, and store harmful substances appropriately. substances appropriately.

HANDLING, STORAGE AND HANDLING, STORAGE AND TRANSPORTATIONTRANSPORTATION

Procedures should be in place to:Procedures should be in place to:

- Sort Sort out out food and food ingredients food and food ingredients fromfrom material material

which is clearly unfit for human consumption;which is clearly unfit for human consumption;

- Dispose of any rejected material in a hygienic Dispose of any rejected material in a hygienic

manner; and;manner; and;

- Protect food and food ingredients from Protect food and food ingredients from

contamination by pests, chemical, physical or contamination by pests, chemical, physical or

microbial contaminants or other objectionable microbial contaminants or other objectionable

substances during handling, storage and substances during handling, storage and

transporttransportationation..

Appropriate facilities and cleaning Appropriate facilities and cleaning

procedures procedures

CLEANING, MAINTENANCE AND CLEANING, MAINTENANCE AND PERSONNEL HYGIENEPERSONNEL HYGIENE

ESTABLISHMENT: DESIGN ESTABLISHMENT: DESIGN AND FACILITIESAND FACILITIES

OBJECTIVESOBJECTIVES - - Minimize contamination;Minimize contamination;

- - PPermit appropriate maintenance, ermit appropriate maintenance, cleaning and cleaning and sanitizingsanitizing

BUILDINGBUILDING

Establishments should be built away fromEstablishments should be built away from

PPolluted areas and industrial activities olluted areas and industrial activities which which

pose a threat for contamination of foodpose a threat for contamination of food;;

AAreas subject to floods, unless sufficient reas subject to floods, unless sufficient

safeguards are provided;safeguards are provided;

areas prone to infestations by pestsareas prone to infestations by pests;;

AAreas where waste (solid or liquid) cannot be reas where waste (solid or liquid) cannot be

removed effectively.removed effectively.

MAINTENANCEMAINTENANCE

– Maintain roads, yards, and parking to avoid Maintain roads, yards, and parking to avoid

contamination of areas where food is exposed;contamination of areas where food is exposed;

– Adequately drain areas that may Adequately drain areas that may

contribute to contamination of food by contribute to contamination of food by

foodborne filth, or provide conditions for nesting foodborne filth, or provide conditions for nesting

and breeding of for pests;and breeding of for pests;

– Operate systems for waste treatment and Operate systems for waste treatment and

disposal in an adequate mannerdisposal in an adequate manner..

PREMISES AND PREMISES AND WORKING AREASWORKING AREAS

• Design and layoutDesign and layout

- protect against cross-contaminationprotect against cross-contamination

- control process flowcontrol process flow

Internal structures and fittingsInternal structures and fittings

WWalls and floors;alls and floors; Ceilings and overhead fixtures;Ceilings and overhead fixtures;Windows;Windows; DDoors;oors; Working surfaces; Working surfaces; Establishments;Establishments; SSewage lines. ewage lines.

EQUIPMENTEQUIPMENT

SanitationSanitation and and maintenance maintenance to avoid to avoid contaminationcontamination::

– Construction materialConstruction material

– DurabilityDurability

– MMaintenance, aintenance, Sanitation, MSanitation, Monitoringonitoring

Program of pProgram of preventive maintenancereventive maintenance

-ListList of equipment requiring regular of equipment requiring regular

maintenance.maintenance.

-PProcedures and frequencies of maintenance rocedures and frequencies of maintenance

are based on are based on instructions from the instructions from the

mmanufacturers or on operating conditions.anufacturers or on operating conditions.

FACILITIESFACILITIES

• Water supplyWater supply• Drainage and waste disposalDrainage and waste disposal• CleaningCleaning• Facilities for pFacilities for personnel hygieneersonnel hygiene• TToiletsoilets• Temperature controlTemperature control• Air quality and ventilationAir quality and ventilation• LightingLighting• StorageStorage

CONTROL OF CONTROL OF

OPERATIONSOPERATIONS

ObjectivesObjectives

Production of safe and suitable food for Production of safe and suitable food for human consumption ensuring:human consumption ensuring:

requirements requirements forfor raw materials, raw materials, composition, processing, distribution, composition, processing, distribution, and consumer use; and consumer use;

designing, implementing, monitoring designing, implementing, monitoring and reviewing control systems. and reviewing control systems.

Control of Food Hazards

identify any points in the operations identify any points in the operations

which which are critical to the safety of are critical to the safety of

food;food;

implement effective control procedures; implement effective control procedures;

ensure effectivenessensure effectiveness of procedures of procedures;;

review procedures periodically.review procedures periodically.

Examples of general proceduresExamples of general procedures

Product Product compositioncomposition current written current written compositioncomposition details of details of formulationformulation

Food additivesFood additives

MManufacturer should guarantee that all anufacturer should guarantee that all additives in use:additives in use:

are approved for the food being are approved for the food being produced;produced;

complycomply with the specific laws with the specific laws and and regulationsregulations; ;

are pure;are pure;

provideprovide certifications for each lot certifications for each lot comply comply with legal limits.with legal limits.

Label accuracyLabel accuracy

The manufacturer should ensure that the label The manufacturer should ensure that the label provideprovidess::

• accurate information of net contents; accurate information of net contents; • manufacturer’s, packer’s and/or manufacturer’s, packer’s and/or

distributor’s namesdistributor’s names and addresses and addresses; and; and• instructions for proper handling by the instructions for proper handling by the

consumerconsumer

Time and temperature Time and temperature controlcontrol

Time and temperature Time and temperature

controlcontrol

Such controls include time and Such controls include time and

temperature of: temperature of: CookingCooking

CoolingCooling

Processing Processing

StorageStorage

Temperature control systems Temperature control systems should take into account:should take into account:

nature of the foodnature of the food

intended shelf-life of the productintended shelf-life of the product

method of packaging and processingmethod of packaging and processing

intended useintended use

SSpecify limits for time and temperature pecify limits for time and temperature variationvariation

Calibration and verification of Calibration and verification of equipment and instrumentsequipment and instruments

Metrologic verificationMetrologic verification

Set of operations needed to assure that a Set of operations needed to assure that a

measuring equipment complies with measuring equipment complies with

standards and requirements for the standards and requirements for the

intended use.intended use.

Specific process stepsSpecific process steps

• cchillinghilling

• thermal processingthermal processing

• irradiationirradiation

• dryingdrying

• chemical preservation chemical preservation

• packaging in packaging in vacuum or modified vacuum or modified atmospheatmospheerer

Microbiological cross Microbiological cross contaminationcontamination

Pathogens can be transferred from Pathogens can be transferred from

one food to another, either by direct one food to another, either by direct

contact, by food handlers, through contact, by food handlers, through

common contact with surfaces, or common contact with surfaces, or

through the air.through the air.

Chemical and physical Chemical and physical contaminationcontamination

Contamination of food by foreign Contamination of food by foreign

mattersmatters such as glass or metal such as glass or metal

particlesparticles, dust, harmful fumes and , dust, harmful fumes and

unwanted chemicals.unwanted chemicals.

RAW MATERIAL AND INGREDIENTS

Reception:

– Manufacturer

– Specifications

– Chemicals

– Inspection of raw material

PACKAGING

• Packaging materials

• Protection of food

• Prevent recontamination

WATERWATER

• Water Quality Water Quality

• ChlorineChlorine

• AnalysisAnalysis

• Cleaning of reservoirsCleaning of reservoirs

• Ice Ice makingmaking

• Steam productionSteam production

• DrainageDrainage

• PlumbingPlumbing

Aspects to be considered:Aspects to be considered: adequate sourceadequate source

appropriate temperature and appropriate temperature and

pressurepressure

separated system according to useseparated system according to use

allowed disinfecting agents allowed disinfecting agents

control of drinking watercontrol of drinking water

• MonitoringMonitoring• Correcting deviationsCorrecting deviations• RecordsRecords• Water standards: WHOWater standards: WHO

MANAGEMENT AND MANAGEMENT AND SUPERVISIONSUPERVISION

• The type of control and supervision The type of control and supervision

needed will depend on the size of the needed will depend on the size of the

business, the nature business, the nature of theof the activities activities

and the types of food and the types of food being produced. being produced.

• Managers and supervisors should Managers and supervisors should have enough knowledge of have enough knowledge of principles principles of of food hygienefood hygiene

DOCUMENTATION AND DOCUMENTATION AND RECORDSRECORDS

Monitoring timeMonitoring time

LegibilityLegibility

Revising and updating recordsRevising and updating records

RECALL PROCEDURESRECALL PROCEDURES

Recall information should include the Recall information should include the following:following:

- Amount of product produced, in inventory Amount of product produced, in inventory and distributed.and distributed.

- Name, size, code or lot numbers of food Name, size, code or lot numbers of food recalledrecalled

- Area of distributionArea of distribution

- Reason for the recallReason for the recall

- Final disposition of the product (rework, Final disposition of the product (rework, discharge, etc.)discharge, etc.)

Storage Storage

• Temperature conditionsTemperature conditions

• Relative humidityRelative humidity

• Air velocityAir velocity

• FIFO (First FIFO (First IIn First n First OOut)ut)

BUILDINGBUILDINGMAINTENANCE AND MAINTENANCE AND

SANITATIONSANITATION

OBJECTIVESOBJECTIVES

To establish effective systems to ensure To establish effective systems to ensure

appropriate maintenance and cleanappropriate maintenance and cleaning,ing,

pest controlpest control,, waste management and waste management and

effective monitoring.effective monitoring.

Biofilm:Biofilm:

• AdhesionAdhesion• ProtectionProtection• ResistanceResistance

CLEANING PROCEDURES CLEANING PROCEDURES ANDAND METHODSMETHODS

Cleaning and sanitizing normally Cleaning and sanitizing normally requirerequire the following steps: the following steps:

1.1. Dry cleanDry clean

2. Pre-rinse 2. Pre-rinse

3. Detergent application (may include 3. Detergent application (may include scrubbing)scrubbing)

4. Post-rinse; and4. Post-rinse; and

5. Sanitizer application.5. Sanitizer application.

CLEANING PROGRAMSCLEANING PROGRAMS

Where written cleaning programs are Where written cleaning programs are used, they should specify:used, they should specify:

- areas, items of equipment and utensils areas, items of equipment and utensils

to be cleanedto be cleaned

- responsibility for responsibility for specificspecific tasks tasks

- method and frequency of cleaningmethod and frequency of cleaning

- monitoringmonitoring

CLEANING OF EQUIPMENTCLEANING OF EQUIPMENT

• CIP (CIP (clean-in-placeclean-in-place). ).

• manualmanual

• automaticautomatic

• immersionimmersion

• drydryinging

CLEANING OF PREMISESCLEANING OF PREMISES

• areas to be cleaned;areas to be cleaned;

• methods of cleaning;methods of cleaning;

• person responsible; andperson responsible; and

• frequency of the activityfrequency of the activity

DETERGENTSDETERGENTS

• General useGeneral use

• Alkaline or chlorinated detergentsAlkaline or chlorinated detergents

• Acid Acid detergents detergents

• EnzymEnzymaticatic detergents detergents

• Contact timeContact time

• TemperatureTemperature

• Physical disruption of the soil Physical disruption of the soil (scrubbing)(scrubbing)

• Water chemistryWater chemistry

Cleaning effectiveness will depend Cleaning effectiveness will depend upon several basic factors: upon several basic factors:

SANITATION AGENTSSANITATION AGENTS

• ChlorineChlorine

• Quaternary Ammonium CompoundsQuaternary Ammonium Compounds

• Iodophors, Iodophors,

• Acid sanitizers includAcid sanitizers includinging acid- acid-anionianionium,um,carboxylic and peroxyacetic acid carboxylic and peroxyacetic acid typestypes

• OzoneOzone

• Ultraviolet(UV) irradiationUltraviolet(UV) irradiation

• Hot (hot water)Hot (hot water)

PEST CONTROLPEST CONTROL

Preventing accessPreventing access

• Entrance sitesEntrance sites

• External and Internal inspection External and Internal inspection

• Assess the facility’s capacity for Assess the facility’s capacity for excluding pests.excluding pests.

Harborage and Harborage and infestationinfestation

• Availability of food and waterAvailability of food and water

• Effectiveness of cleaning andEffectiveness of cleaning and

sanitation proceduressanitation procedures

Monitoring and Monitoring and detectiondetection

• Observations of the presenceObservations of the presence

• Evidence of the presenceEvidence of the presence

Eradication

Agents:Agents:

• ChemicalChemical

• PhysicalPhysical

• Biological Biological

Waste Management

• Storage AreasStorage Areas

• Waste bins, tubs and dumpstersWaste bins, tubs and dumpsters

• Proper cleaning and sanitizingProper cleaning and sanitizing

SANITATION SANITATION MONITORING MONITORING

EFFECTIVENESSEFFECTIVENESS

Sanitation systems program Sanitation systems program periodically verified periodically verified

– Audit pre-operational inspections,Audit pre-operational inspections,

– Microbiological sampling of environment Microbiological sampling of environment and food contact.and food contact.

PERSONAL HYGIENE

ObjectiveObjective

To ensure To ensure that that those who come directly or those who come directly or

indirectly into contact with food are not indirectly into contact with food are not

likely to contaminate it.likely to contaminate it.

HEALTH STATUSHEALTH STATUS

• IllnessIllness

• InjuriesInjuries

• Individual Health CardIndividual Health Card

PERSONAL CLEANLINESSPERSONAL CLEANLINESS

Personal effectsPersonal effects

Hand washingHand washing

Use of antiseptic on Use of antiseptic on

handshands

UNIFORMUNIFORM

• UniformUniform– Uniforms should be kept clean and in good Uniforms should be kept clean and in good

condition.condition.

• Masks and glovesMasks and gloves

– should be used when a ready-to-eat food is should be used when a ready-to-eat food is preparedprepared

PERSONALPERSONALBEHAVIORBEHAVIOR

• Trained to be conscious of the Trained to be conscious of the importance of GMPimportance of GMP

• Unacceptable ActionUnacceptable Action

VISITORS

Adhere to the same personal Adhere to the same personal

hygienhygienicic provisions described for provisions described for

food handlers. food handlers.

TRANSPORTATIONTRANSPORTATION

OBJECTIVESOBJECTIVES

• To protect food from potential sources of To protect food from potential sources of contamination and from damage likely to render contamination and from damage likely to render food unsuitable for consumption;food unsuitable for consumption;

• To provide an environment which limits growth To provide an environment which limits growth of pathogenic or spoilage microorganisms and of pathogenic or spoilage microorganisms and the production of toxins. the production of toxins.

RequirementsRequirements

• design and constructdesign and constructionion• clean and/or disinfectclean and/or disinfect• separate foods from non-food itemsseparate foods from non-food items• maintain temperaturemaintain temperature• verification of temperatureverification of temperature• prevent contaminationprevent contamination

VERIFICATIONVERIFICATION

- - Inspection of vehicleInspection of vehicle

- Program describing effective cleaning and - Program describing effective cleaning and sanitation proceduressanitation procedures

- Restrain transportation of non-food items - Restrain transportation of non-food items

- Loading- Loading//unloadingunloading

- Design and construct- Design and constructionion of tank vehicles of tank vehicles

- Materials used- Materials used in in vehicles vehicles for for food tfood transportationransportation

PRODUCT INFORMATION PRODUCT INFORMATION AND CONSUMER AND CONSUMER

AWARENESSAWARENESS

OBJECTIVESOBJECTIVES

– All products should be labeled with sufficient All products should be labeled with sufficient

information to ensure that the information to ensure that the person in the person in the next next

step ofstep of the food chain will understand how to the food chain will understand how to

handle, store, process, prepare and display the handle, store, process, prepare and display the

product safely and correctlyproduct safely and correctly ; ;

– This information should This information should contain a clearcontain a clear

identifidentificationication of of the lot or batch in order to the lot or batch in order to

facilitate any necessary recall.facilitate any necessary recall.

Lot identificationLot identification

A lot is a defined quantity of a commodity A lot is a defined quantity of a commodity produced under the same conditionsproduced under the same conditions..

Lot identification is essential to product Lot identification is essential to product recall and also contributes to effective recall and also contributes to effective stock rotationstock rotation. .

Product informationProduct information

Adequate label information on food products Adequate label information on food products enables the next person in the food chain to enables the next person in the food chain to handle, display, store, prepare and use the handle, display, store, prepare and use the product safely and correctly.product safely and correctly.

LabelingLabeling

““Codex of General Standard for the Codex of General Standard for the

Labeling of Prepackaged Foods” Labeling of Prepackaged Foods”

(CODEX STAN 1-1985). (CODEX STAN 1-1985).

The minimum information required on The minimum information required on prepackaged labels is: prepackaged labels is:

Name of the foodName of the food

IngredientsIngredients

Net contents and drained weightNet contents and drained weight

Name and address of manufacturer, Name and address of manufacturer, packager, distributor, importer, exporter packager, distributor, importer, exporter or vendor of the foodor vendor of the food

Country of origin;Country of origin;

Lot identification;Lot identification;

Date and storage instructions;Date and storage instructions;

Instructions for use.Instructions for use.

Consumer Consumer educationeducation

• Health education programs should cover Health education programs should cover general food hygiene;general food hygiene;

• Helping consumers to understand the Helping consumers to understand the importance of reading labels, following importance of reading labels, following instructions for use, and making correct instructions for use, and making correct choices;choices;

• Information on the relationship between Information on the relationship between time/temperature control and foodborne time/temperature control and foodborne diseasesdiseases

TRAININGTRAINING

• Awareness and responsibilitiesAwareness and responsibilities

• Training programsTraining programs

• Instruction and supervisionInstruction and supervision

• RefreshRefreshinging training training

• Minimum program for GMP training coursesMinimum program for GMP training courses

• Code of Code of Hygyenic Hygyenic Practices Practices -- Codex Codex

AlimentariusAlimentarius Commission Commission

Minimum program forMinimum program for

GMP training coursesGMP training courses

• Primary Primary pproduction;roduction;• Design of plant and facilitiesDesign of plant and facilities• Control Control oof f ooperations;perations;• Plant mPlant maintenance aintenance aand nd ssanitation;anitation;

• Transportation;Transportation;

• Product information and consumer Product information and consumer awareness;awareness;

• Training;Training;• GMP evaluation.GMP evaluation.

GOOD MANUFACTURING GOOD MANUFACTURING PRACTICE EVALUATIONPRACTICE EVALUATION

VerificationVerification

AuditAudit