PART II GOOD MANUFACTURING PRACTICES (GMP). GMP Prerequisite programs which will provide the basic...
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Transcript of PART II GOOD MANUFACTURING PRACTICES (GMP). GMP Prerequisite programs which will provide the basic...
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