What is GMP ?• WHO defines Good Manufacturing Practices (GMP) as“quality assurance which ensures the quality standardsappropriate to their intended use and as required by themarketing authorization.”• GMP covers all aspects : defined manufacturingprocess; validated critical manufacturing steps; suitablepremises, storage, transport; qualified and trainedproduction and quality control personnel; adequatelaboratory facilities; approved written procedures andinstructions; records to show all steps of definedprocedures have been taken; full traceability of aproduct through batch records and distribution records;and systems for recall and investigation of complaints.
Pest control• Food plants must have structures to controlinsects, rodents, birds, cats and other animals.• Doors, windows and other openings must besecured.• Openings that are typically left open forventilation should be screened. Installation of aircurtains, fans and electrocutors at strategiclocations will be extremely helpful.• Snap traps, glue boards and bait stations mustbe placed around the immediate buildingexterior and interior walls.
Building design and construction• The ground selected should be above the road level and waterdrainage system.• The building should be a few feet above ground level for cleaningwater to flow out.• Adequate protection should be provided against rain and duststorms.• Areas for incoming raw material and outgoing finished goodsshould be segregated.• Lighting and ventilation systems should be adequate for visibilityand safety.• All entry points to the building should be secured against insects,rodents and other animals.• The doors, windows, walls, floors and ceilings should be made ofsmooth surfaces that can be easily wiped and cleaned.• Materials used in construction of floors and walls should benontoxic.
Sanitary, Facilities And Control• Toilets and hand-washing facilities must be providedinside the processing centre;• Toilet tissue must be provided;• Toilets must be kept sanitary and in good repair;• Toilet rooms must have self-closing doors;• Hand-washing facilities must provide:o Running water at a suitable temperature;o Effective hand-cleaning and hand-sanitizing preparations;o Clean towel service or suitable drying devices;o Easily cleanable waste receptacle;o Water control valves designed and constructed to protectagainst recontamination of clean, sanitized hands;
Equipment and Utensils• Equipment and utensilsmust be designed foreasy cleaning andsanitation.• Equipment and utensilsmust be made fromnon-corrosive materials.
Raw material, Ingredient and Storage• Raw product andfinished product must bestored in segregatedareas under conditionsthat preventcontamination and thegrowth of undesirablemicroorganisms.• Product flow zones mustbe protected from allsources ofcontamination.
Recommended InternationalCode of Practice-GeneralPrinciples of Food Hygiene
Codex Alimentarius Commision(CAC)• Codex standard• The reference for international food safetyrequirements- Code of practice – General Principles ofFood Hygiene- Hazard Analysis and Critical Control Point(HACCP)GMP Codex (Good ManufacturingPractice) : a pre-requisite program ofHACCP
CAC/RCP 1-1969, Rev.4 - 2003 I : Objective II : Scope, Use and Definition III : Primary Production IV : Establishment : Design and Facilities V : Control of Operation VI : Establishment : Maintenance and Sanitation VII : Establishment : Personal Hygiene VIII: Transportation IX : Product Information and ConsumerAwareness X : Training
SECTION I - OBJECTIVE• Identify the essential principle of foodhygiene applicable throughout the foodchain• Recommend a HACCP-based approachas a means to enhance food safety• Indicate how to implement those principles• Provide a guidance for specific codeswhich may be needed for – sectors of thefood chain
SECTION II – SCOPE, USE ANDDEFINITION• Scope : Food Chain, Roles of Government,Industry and Consumer• Use :– Each section indicates both the objectives to beachieved and the rationale behind thoseobjectives in terms of the safety and suitability offood– What is necessary and appropriate on the groundof the safety and suitability of food forconsumption ?– “Where necessary” and “where appropriate”
Problems in food supply chain• Transparency and geographycal location• Analysis and control of risk• Co-operation/openness in supply chain• Define, translate and control requirementsfinished products throughout the chain• Validation / control changes• Control suppliers
Communication along the supply chainCrop produsersFeed producersPrimary food producersFood processors2nd food processorsWholesalersRetailersConsumerProducers of pesticides,Fertilizers and veterinary drugsFood chain for the productionOf ingredients and additivesTransport and storageoperatorsProducers of equipmentProducers of cleaning agentsProducers of packagingmaterialsService providersOther supplying food chainRegulatoryAuthorities
SECTION III – PRIMARYPRODUCTION• Objectives : primary production should bemanaged in a way that ensures that food issafe and suitable for its intended use.• Where necessary, this will include :– Avoiding the use of areas where the environmentpoces a threat to the safety of food– Controlling contaminant, pests and diseases ofanimals and plants in such a way as not to posea threat to food safety– Adopting practices and measures to ensure foodis produced under appropriately hygienicconditions
SECTION IV – ESTABLISHMENT :DESIGN AND FACILITIES• Objectives : Depending on the nature of theoperations, and the risks associated with them,premises• Equipment and facilities should be located,designed and constructed to ensure that– Contamination is minimized– Design and layout permit appropriate maintenance,cleaning and disinfections and minimize air-bornecontamination– Surfaces and materials, contacted with food, are non-toxic, suitable durable and easy to maintain and clean
SECTION V – CONTROL OFOPERATION• Objective : to produce food which is safeand suitable for human consumption by :– Formulating specific design requirements forraw materials, composition, processing,distribution and consumer– Designing, implementing, monitoring andreviewing effective control systems
SECTION VI – ESTABLISHMENT :MAINTENANCE AND SANITATION• Objective :– To establish effective systems to : ensureadequate and appropriate maintenance andcleaning :• Control pests• Manage waste• Monitor effectivenessof maintenance andsanitation procedures
DEFINITION Sanitation Standard Operating Procedures isthe common name give to the sanitationprocedures in food production plants which arerequired by the Food Safety and InspectionService of the USDA and regulated by 9 CFR part416 in conjunction with 21 CFR part 178.1010. It isconsidered one of the prerequisite programs ofHACCP Sanitation Standard Operating Procedures —SSOPs — are the specific, written proceduresnecessary to ensure sanitary conditions in thefood plant. They include written steps for cleaningand sanitizing to prevent product adulteration.
SSOP’s can be very simple to extremelyintricate depending on the focus.Food industry equipment should beconstructed of sanitary design; however someautomated processing equipment by necessityis difficult to clean.An individual SSOP should include:1.The equipment or affected area to be cleaned,identified by common name,2.The tools necessary to prepare the equipmentor area to be cleaned3.How to disassemble the area or equipment4.The method of cleaning and sanitizing
Pre-operational SSOPs• Describe the daily, routine sanitary proceduresthat occur before processing begins.• the cleaning of product contact surfaces offacilities, equipment, and utensils to prevent directproduct contamination or adulteration.• These might include:1.) Descriptions of equipment disassembly,reassembly after cleaning, use of acceptablechemicals according to label direction, andcleaning techniques.2.) Application instructions, including concentrations,for sanitizers applied to product contact surfacesafter cleaning.
Established procedures during operationsmight include, where applicable:1) Equipment and utensilcleaning/sanitizing/disinfecting duringproduction, as appropriate, at breaks, betweenshifts, and at mid-shift cleanup.2) Procedures for employee hygiene, such ascleanliness of outer garments and gloves, hairrestraints, handwashing, health, etc.3) Product handling in raw and in cooked productareas.
• SAFE WATER--SSOP item 1Safety of the water that comes into contact with food orfood contact surfaces, or is used in the manufacture ofice; Existing Conditions:• CLEAN FOOD CONTACT SURFACES: SSOP item 2Condition and cleanliness of food contact surfaces,including utensils, gloves, and outer garments• PREVENT CROSS-CONTAMINATION - SSOP item 3Prevention of cross-contamination from insanitaryobjects to food, food packaging material, and other foodcontact surfaces, including utensils, gloves, and outergarments; and from raw product to cooked product;• EMPLOYEE HYGIENE - SSOP item 4Maintenance of hand washing, hand sanitizing, and toiletfacilities;
ADULTERATION - SSOP item 5Protection of food, food packaging material, andfood contact surfaces from adulteration withlubricants, fuel, pesticides, cleaning compounds,sanitizing agents, condensate, and otherchemical, physical, and biological contaminants; TOXIC COMPOUNDS - SSOP item 6Proper labeling, storage, and use of toxiccompounds. EMPLOYEE HEALTH - SSOP item 7Control of employee health conditions that couldresult in the microbiological contamination offood, food packaging materials, and food contactsurfaces.
The person in charge shalldemonstrate this knowledge by :a) Complying with this Code by having no criticalviolations during the current inspection;b) Being a certified food protection manager whohas shown proficiency of required informationthrough passing a test that is part of anaccredited program; orc) Responding correctly to the inspector’squestions as they relate to the specific foodoperation. The areas of knowledge include:1) Describing the relationship between theprevention of foodborne disease and the personalhygiene of a food employee;
2) Explaining the responsibility of the person incharge for preventing the transmission offoodborne disease by a food employee who hasa disease or medical condition that may causefoodborne disease;3) Describing the symptoms associated with thediseases that are transmissible through food;4) Explaining the significance of the relationshipbetween maintaining thetime and temperature ofpotentially hazardous food and the prevention offoodborne illness;5) Explaining the hazards involved in theconsumption of raw or undercooked meat,poultry, eggs and fish;
6) Stating the required food temperatures and timesfor safe cooking of potentially hazardous foodincluding meat, poultry, eggs, and fish;7) Stating the required temperatures and times for thesafe refrigerated storage, hot holding, cooling, andreheating of potentially hazardous food;8) Describing the relationship between the preventionof foodborne illness and the management andcontrol of the following:a) Cross contamination,b) Hand contact with ready-to-eat foods,c) Handwashing, andd)Maintaining the food establishment in a cleancondition and in good repair;
10) Explaining correct procedures forcleaning and sanitizing utensils andfood-contact surfaces of equipment;11) Identifying the source of water usedand measures taken to ensure that itremains protected fromcontamination such as providingprotection from backflow andprecluding the creation of crossconnections;12) Identifying poisonous or toxicmaterials in the food establishmentand the procedures necessary toensure that they are safely stored,dispensed, used, and disposed ofaccording to law;
Continued…13) Identifying critical control points in theoperation from purchasing through sale orservice that when not controlled maycontribute to the transmission of foodborneillness and explaining steps taken to ensurethat the points are controlled in accordancewith the requirements of this regulation;14) Explaining the details of how the person incharge and food employees comply with theHACCP plan if a plan is required by thelaw or an agreement between the regulatoryauthority and the establishment;
SECTION VII – ESTABLISHMENT :PERSONAL HYGIENE• Objective : to ensure thatthose who come directly orindirectly into contact withfood are not likely tocontaminate food by :– Maintaining an appropriatedegree of personalcleanliness– Behaving and operating inan appropriate manner
Conditions and theefforts necessary toprevent food frompossible contaminationof biological, chemicaland physical objectswhich can beannoying, harmful anddangerous to humanhealth.Food Safety
1. Food sanitation2. Use of food additive3. Genetic engineering4. Irradiation of food5. Food packaging6. Quality assurance offood7. Food contaminated8. Expired food
Prevention of contamination1. Protection from Bacterial Contamination Food providing from safe origin Contaminated prevention by minimum handcontact, food covering, raw and cookedfood separation, waste bin covering andanimal prevention Prevention of contamination channels;single usage of knives and spoons, contactsurface cleaning with disinfectants andequipment separation
2. Prevention of the bacterial growthFactors on bacteia growing in food :
Methods of destroy microorganisms(food processing)
1. Food as Vectors of Pathogens• Food or waters may act merely as vectors of apathogenic species, there is no requirement forthe pathogen to grow or multiply in the food.• Only a very small number of the pathogen cells(<100) need to be consumed to bring about aconsumer response or reaction• These include : typhoid (Salmonella typhi),Dysentry (Shigella dysenteriae), Cholera (Vibriocholerae) and Tuberculosis (Mycobacterium)
2. Food as Substrates for Pathogen Growth• Food act as substrates for the growth andmultiplication of pathogenic species,which, when developed high enoughnumbers, cause illness on humanconsumption.• These are the classical cases of microbialbased food poisoning.• Two sub-groupings may be recognize :a. Consumer infectionb. Consumer intoxication
a. Consumer Infection• Upon consumption the pathogenic speciesconcerned multiplies in the alimentarytract thereby bringing about consumerresponse or reaction.• Consumer symptoms are generally feltafter an incubation period of 12-24 hours• Ex : Salmonella sp, Clostridiumperfringens, Vibrio parahaemolyticus,enteropathogenic Escherichia coli strainsand Shigella sp.
b. Consumer Intoxitation• In this case it is the consumption of a toxicproduct previously produced in the food bymicrobial growth which brings about aconsumer response.• Symptoms are generally felt much sooner(3-12 hours) after food consumption.• Ex : Staphylococcus aureus andClostridium botulinum
Causative Organisms of Food-borne Disease1. Salmonella sp.• Salmonella food poisoning is mainlyassociated with freshly cooked meat andpoultry products which is have in some waybeen undercooked and mishandled beforeconsumption.• The cycle of Salmonella food poisoningtransmission may be summarised as follow :Animal BirdWasteAnimal FoodFood ManFaeces
2. Clostridium perfringens• C. perfringens occurs widely in theenvironment and is perhaps the mostwidely distributed of all bacterialpathogens.• It is natural inhabitant in the intestines ofmany healthy humans, animals and birds• Meat and poultry products are frequentlycontamined with this organisms.
3. Staphylococcus aureus• S. aureus is closely associated withhumans and other animals-in particularskin, nose cooked food product.4. Vibrio parahaemolyticus• They are found mostly in estuarine andnear coastal waters and thereforenaturally contamine most seafoodproducts
5. Bacillus cereus• Survey on the incidence of this organismin foods show a high frequency ofincidence in dried foods, such as cereals,spices and powdered milk.6. Clostridium botulinum• It occurs in soils, waters and marinesediments an may contaminate a widevariety of products such as fruits,vegetables, meats, seafoods, from homepreserved food products (canned/bottledfruits and vegetables)
7. Escherichia coli• The organism enters kitchen and foodpreparation areas in many raw foodstuffs andreadily passes to cooked foods by usual meansof hands, surfaces, containers, and otherequipment8. Shigella sp.• Milk and oysters have been incriminated inshigellosis outbreaks in the past, and becauseare also considered of the low infective dose ofthese species, contaminated water supplies arealso considered as important causes of thisdisease
SECTION VIII -TRANSPORTATION• Objective : measure should be takenwhere necessary to :– Protect food from potential sources ofcontamination– Protect food from damage– Provide an environment which effectivelycontrols the growth of pathogenic or spoilagemicro-organisms and the production of toxinin food
SECTION IX – PRODUCT INFORMATIONAND CONSUMER AWARENESSOBJECTIVES• Products should bear appropriate information toensure that :– Adequate and accessible information is available to thenext person in the food chain to enable them to handle,store, process, prepare and display the product safelyand correctly– The lot or batch can be easily identified and recalled ifnecessary• Consumers should have enough knowledge of foodhygiene to enable them to :– Understand the importance of product information– Make informed choices appropriate to the individual– Prevent contamination and growth or survival offoodborne pathogens by storing, preparing and using itcorrectly
SECTION X - TRAINING• OBJECTIVES– Those engaged in food operations who comedirectly or indirectly into contact with foodshould be trained, and or instructed in foodhygiene to a level appropriate to theoperations they are to perform
Food Safetyan HACCP ApproachHazard Analysis Critical Control PointIs a systematic approach to be used in foodproduction as a means to ensure foodsafety.The first step requires hazard analysis, anassessment of risks associated with allaspects of production from growing toconsumption.
Why HACCP• Because HACCP is theonly practical approach (currently tested)• However, HACCP is notwithout risk, HACCP minimize the riskofharm (physical, chemical and biological)
How HACCP prevents contamination..??• Identify sourcesof potential contamination (proactive)• Take action to prevent (preventive)• Monitoring measures to ensure theeffectiveness of (effective)• Dynamics that always follow thedevelopment of HACCP(anticipatory)
HACCP refine thetraditional examination system• HACCP system is more emphasis on theproduction process• HACCP focuses on each stageof the critical points that affect thesafety ofproducts• HACCP in the importance ofcommunication between the industry,between industries and policy makers
HACCP benefits for the industry• Security system (safety) are accepted regionally and internationally• Bring more information and a betterunderstanding of products and processes• Participation and a better understanding offood safety programs(food safety)• Reduce the level of non-conformityAs a support to the implementationof TQM
A Sequence steps to implementHACCP Assemble the HACCP team and Training Set-up company’s Food safety Policy Describe the product description Identify intended use Construct flow diagram On site verification of flow diagram (pre-requisite) Follow the seventh HACCP Principles Product identification and traceability (RecallProduct) Establish procedure for consumer complaint Validation for implementation
The Seventh Principles of HACCP• Principle 1: Conduct a hazard analysis.• Principle 2: Identify critical control points.• Principle 3: Establish critical limits for each criticalcontrol point.• Principle 4: Establish critical control point monitoringrequirements.• Principle 5: Establish corrective actions.• Principle 6: Establish record keeping procedures.• Principle 7: Establish procedures for verifying theHACCP system is working as intended.
Hazard Analysis A significant hazard are :Reasonably likely to occurLikely to result in an unacceptable risk to consumer (react and result toxins, etc)The qualitative and quantitative evaluation of the presence of hazards
Below is an example flow chart in tabular formfor a typical fruit and vegetable processing plant.
Product Description• The description will include all applicable information on the product which help in assesing risk and establishing Critical Control Point (CCP) • Information typically included in such descriptions are product name, target market, how the product will be used, the type of packaging, label instruction, an ingredients list, shelf life and handling requirements.
Risk Assessment• For each model used, the risk on the product and its ingredients will be ascertained using establish criteria for assessing microbiological risk.• The risk values stated for each product and component ingredients are not “carved in stone”
COMPREHENSIVE PRODUCT CONTROLLOW SAFETY RISKHIGH SAFETY RISKHACCP QC / TQCBiologicalCCP’sPhysicalCCP’sChemicalCCP’sSanitationCP’sGMPCP’sEquipmentCP’sProductCP’sRegulatoryCP’sRelationship between high risk and lowrisk concerns for a food product
CCP and CP Decision treeQUESTION :IF I LOSE CONTROL, IS IT LIKELY THAT AHEALTH RISK WILL OCCURCONTROL POINTCRITICAL CONTROL POINTCCP or CP ?NOYESExamples :•Pasteurization of milk•Thermal process for canned foods•Refrigerations of minimally processedchilled foods•Metal detector on ground beef lineExamples :•Food bath in canning facility•Hand wash station in a frozenvegetable plant•Chloranation of mixing kettles in acanned food operation•Pest control in a cheese plant
CCP Decision TreeYesYesModify step, Processor ProductIs control at this stepnecessary for safetyQ1. Do preventive measure(s) existor sub-sequent step for theidentified hazard ?Q2. Does this step eliminate orreduce the likely occurance of ahazard to an acceptable level ?Q3. Could the hazard increasae to anunacceptable or could contaminationincrease to unacceptable level ?Q4. Will a subsequent step eliminateidentified hazards or reduce likelyoccurrence to an acceptable level ?Critical Control PointNot a criticalControl PointNoYesYesYesNoNoNoNo
3. Process Flow Charts• Creation of accurate process flow charts is one step in developing understanding.• Once the chart has been developed, and the risk assessment are completed, the “HACCP Team” may begin to assign Critical Control Points.
Canned mushroom(production and processing)2-MReceivingGrading and WeighingPackingTransportPerforated BagsAnd/or Plastic boxesCollection Station4-MCompostSterilizationMushroom Beds in HutsColonize CompostHarvest Hand OperationSpawn(A.bisporus)Casing Oil1. Rice Straw 47%2. Animal Waste 47%3. Bean curd 2,5%4. Urea 0,07%5. MineralsHeat and ChemicalWaterControl R.HTemperatureSeveral flushesPlastic pails≥ 15 cm deepFrom fieldLightIndustry1-MC3-MTRANSPORTTrucks- -No RefrigeratorM =MicrobiologicalC = ChemicalP = PhysicalS = Sanitation
Continued…BoxingIncubationBox UnloadingLabelling(Hand Operation)Casing(Hand Operation)Monitor for Swells22-MFiberDryingRejects, Test to DetermineCause for RejectionDud Detection Tap Tone23-MNew FiberCude Cases with Can Code,Swells/Low Vacs(Rejects)Retort LoadingRetortingCoolingBasket Unloading0,5 ppm Discharge19-MMonitor & Control Critical Factors(IT Fill, Process Time & Temp.Vent ScheduleChlorinated Water20-MHandle to Prevent Abuse20-MM =MicrobiologicalC = ChemicalP = PhysicalS = Sanitation
THE HAZARD ANALYSIS PROCESS The hazard analysis process consists of asking a series of questions at each operational step in the processing of the product as it flows through the plant. The analysis examines the effect of a variety of factors upon the safety of the food. Sample questions are given below.1. INGREDIENTS• Do the produce contain any sensitive ingredients that are likely to present microbiological hazards• What is the normal microbial content of the food stored under proper conditions?• Does the microbial population change while the food I stored before consumption?• Does that change in microbial population alter the safety of the food?
2. FACILITY DESIGN Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat foods? Is positive air pressure maintained in product packaging areas? Is this essential for product safety? Is the traffic pattern for people and moving equipment a potentially significant source of contamination?3. EQUIPMENT DESIGN Will the equipment provide the time and temperature control that is necessary for safe food? Is the equipment properly sized for the volume of produce that will be package? Can the equipment be sufficiently controlled so that the variation in performance will be within the tolerances required to produce a safe food? Is the equipment reliable or is it prone to frequent breakdowns?
Is the equipment designed so that it can be cleaned and sanitized? Is there a chance for product contamination with hazardous substances? What product safety devices, such as time and temperature integrators, are used to enhance consumer safety?3. PACKAGING Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins? Is the packaging material resistant to damage, thereby preventing the entrance of microbial contamination? Is the package clearly labeled “Keep Refrigerated” if this is required for safety? Does the package include instructions for the safe handling and preparation of the food by the consumer? Are tamper-evident packaging features used? Is each package legibly and accurately coded to indicate production lot? Does each package contain the proper label?
Determination Of The Critical Control Points (CCP)
Application of HACCP• Participant should be divided into 5 groupconsisting for 4 people• Each group choose 1 of the followingcomodities and processing (strelization,drying, fermentation)d. Corne. Citrusf. Soy beana. Cassavab. Bananac. Mango Discussfully the HACCP process anddetermine the Critical Operation (CP),Potetial Risk (PR), Control Point (CP) andCritical Control Point (CCP)