Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) 3.1. Introduction GMP the building blocks for HACCP. In several years, producer, retailer and industrialist use Good Manufacturing Practices (GMP) as appropriate method in order to produce good quality of food. Food producers keep on developing GMP regulations. Now, it uses as prerequisite program on HACCP system or food safety system. Good Manufacturing Practices should be selected and adopted before HACCP is implemented. Without the application of CGMP principles, an effective HACCP program cannot be conducted. Furthermore, GMP must be applied to the development of sanitation standard operating procedures (SSOP). Compliance with specific GMP should be included as part of HACCP. The areas that should be addressed through CGMPs are personal hygiene and other practices, buildings and facilities, equipment and utensils, and production and process controls. CGMPs should be broad in nature (Marriot, 2007). There can hardly be HACCP without Good Manufacturing or Management Practices (GMP). Briefly, GMP is a description of all the steps (which should represent good practice) in a processing facility, while HACCP is a documentation that the steps important to consumer health are under control (Arvanitoyannis and Theodoros, 2009) GMP application is also a basic part of Total Quality Management Program (TQMP). GMP application should be explain in briefly and clearly about problems and procedures on every stage on food processing. 3.2. Definition GMP and SSOP are interrelated and an important part of process control. CGMP are the minimum sanitary and processing requirements necessary to ensure the production of wholesome meat. GMP is one of supporting program for implementation of HACCP system. GMP make food product have a good quality and safety; it is also make product widely acceptable for consumers in domestic and international market. Based on Ministry of Marine Affair and Fisheries Regulation (2007), GMP is the guideline on good prerequisite and production procedures on fish processing unit. GMP is a combination of the production and quality control, to ensure that food manufacturers or processing are following the right step of its production line consistenly and spesifically. GMP refers to the regulation that firstly declared by the US Food Drug Administration (FDA) after being revised in 1986. GMP regulation is aimed to protect the consumer to avoid purchasing any dangerous or contaminated products. Its require a good quality approach of manufacturing and processing product to eliminate errors and failure. Nowadays, the function of GMP is getting more important as pre-requisite program of HACCP; therefore it has to be implemented prior the HACCP system together with the application of SSOP. 3.3. Scope According to Darwanto and Murniyati (2003), on operational processing unit, company management should be check on processing activities for evaluating: a. suitability, quality, and all input factor such as fish, food additives, ingredients, packaging, labeling etc; b. control suitability and condition of manufacturing namely construction, maintenance, sanitation, operation, and equipments that are use on fish processing; c. fulfillment of end products requirements are quality, safety, healthy, and also composition and grade of quality on product; d. staff checking on their health, hygiene and qualification. 3.4. GMP components 3.4.1. Location and Building Requirement 3.4.1.1. Location Seafood plant is consider of a suitable location. Some factors should be considered namely physical, geographical and infrastructure available. A plant must be adequate on a plot of adequate size, easy access on transportation by road, rail or water. An adequate of water should be available throughout the year. Seafood plants contain significant amounts of organic matter which must be removed before waste water is discharge into river or the sea. It also solid waste handling needs careful or appropriate planning, appropriate space, must be available. The immediate physical surroundings of a seafood factory should be landscape and present on attractive view to the visitor. Shrubbery should be at least 10 meter away from factory building and a grass free strip covered with a layer of gravel should follow the outer wall of buildings (Huss, 1994). In addition, the factory location should be large enough for expansion and should be attractively landscaped with natural features such as tree retained wherever possible. Paved or asphalt area are needed in factory, car pack should be situated at a reasonable walking distance from the factories to reduce fumes and noise (Forsythe and Hayes, 1998). 3.4.1.2. Building There are several requirements for fish factories buildings. The materials that used on building materials should be have the specific characteristics. There are specific characteristics such as non-porous, non-toxic, easily cleaned, rodent proof, smooth flat, etc. According to Huss (1994), on food processing industries should have the particular characteristics on materials which are use on food industries. Food factories should be designed and built for particular purposes with materials capable of withstanding various physical conditions. The principal factors to consider are heat, cold, humidity, and vibration. On fish processing, interior surfaces should be smooth, non-porous, easily cleaned and not vulnerable to chemical attack by modern detergents and disinfectants, or able to sustain biological/microbiological growth. Good natural light and screened electric light must be provided. Paints and other surface coats should be non-toxic and not flake; those that contain mould inhibitors must not come into contact with foods. Pipe work, drainage ducts, conduits for power supply and other channels should be tightly sealed where they pass through walls, floors and ceilings to prevent entry of vermin and insects (Huss, 1994). Overhead pipe work sometimes passes directly over process lines and water condensed on the pipes can drip on the underlying food and equipment (Forsythe and Hayes, 1998). Ventilation on fish factory have to efficient and ceiling should be constructed of and finished with materials that obviate condensation, paint flatting, and mould growth. The panel construction being made of various PVC, reinforced resins, PVC-faced plasterboard, PVC-foil-faced foam board or plastic-coated steels (Forsythe and Hayes, 1998). Walls should be constructed with durable materials and in certain situation. All wall angles, corners and junctions of walls and floors must be imperiously sealed and be rounded for ease of cleaning. Coving of the wall/floor junction of walls to a height of. C. 15 cm. Modern materials that are used on wall include polypropylene and different PVCs. Suitable polymers and glass-reinforced PVC can be layered on a thin metallic surface with a cladding of suitable insulating materials (Forsythe and Hayes, 1998). Floor is that surface should be non-slip and easy to clean and disinfect. The quality of the floor surface can be improved by topping the concrete with appropriate materials. These include epoxy, polyester or acrylic resins, chlorinated and styrene butadiene rubbers and bituminous paints and mastics. The resins have a number of advantages such as durable, easy to clean, good non-slip surface, smooth but became saturated and absorb water under water condition. Tiles can provide a relatively long lasting and impervious surface. However, there are weaknesses since they crack, lift to be under run by water, and are difficult to replace satisfactory (Forsythe and Hayes, 1998). Ideally, building have to impose no constraints on any process or plant layout. However, production line are sited in unsuitable buildings as an economic necessity. Construction of building can be based on reinforce concrete or steel frame. In the framed structure the external walls are essentially a skin design to protect personnel and equipment inside. It means that the external walls can be constructed of relatively light material namely aluminum (Forsythe and Hayes, 1998). 3.4.1.3. Plant layout Layout of food industries be laid out with clear, preferably ‘straight through lines of product flow. Final or intermediate processes must be separate to avoid cross-contamination by raw materials. According to Kotschevar and Terrell (1977) in Forsythe and Hayes, (1998), there are eight principle in efficiency flow of work in food service area are: function should proceed in proper sequence directly, with a minimum of criss-crossing and backtracking; smooth and rapid production; delay and storage of materials in processing should be eliminated; worker and materials should cover minimum distances; materials and tools should receive minimum handling, and equipment minimum worker handling; maximum utilization of space and equipment should be achieved; quality control must be sought at all critical points; minimum cost production should be sought. With eight principles, these layouts will minimize recontamination of fish process or raw materials. The preparation areas for all raw materials and all product should be physically separated by appropriate walls. The movement of operators between the separate processing areas should be use of allocated colored clothing and control by management. Facilities for washing hands with knee or foot operated hot water taps should be positioned at all pedestrian entrances in food factories as well as in the toilets. Suitable liquid unperfumed soaps, barrier creams and disposable towels must be provided at all times, with instruction given also their proper use. Floors should be durable, smooth, easily cleaned and carefully insulated; in addition, because of the problem of ‘frost heave where the subsoil becomes frozen to a depth of 1-2 cm causing weakening of the foundations, a heating walls and ceiling should also be durable, smooth and easily cleaned; material such as galvanized steel is particularly recommended. Design layout of cold stores should aim at keeping the environment as constant a possible. Thus the entry of warm air should be minimized by providing properly insulated double doors with an air lock and, as with chill rooms, sitting should be some distance form warm processing areas. 3.3. The examples of processing layout A = administration, EA = employee amenities, FPS = final products storage, L = laboratory, P = production area, RMS = raw materials storage (Forsythe and Hayes, 1998 re-draw by the authors) 3.4.1.4. Equipments There are seven basic principles for hygienic design agreed by the Working Party appointed by the Joint Technical Committee of the Food Manufacturers Federation (FMF) and the Food Machinery Association (FMA) in Forshyte and Hayes, (1998). The principle are: all surface in contact with food must be inert to the food under the condition of use and must not migrate; all surfaces in contact with food must be smooth and non-porous so that tiny particles are not caught in microscopic surface crevices and become difficult to dislodge; all surfaces in contact with food must be visible for inspection; all surfaces in contact with food must be readily accessible for manual cleaning; all surfaces in contact with food must be arranged that the equipment is self-emptying or self-draining; equipment must be design as to protect from external contamination; the exterior or non-product contact surfaces should be arranged to prevent harboring of soils, bacteria, or pest in and on the equipment itself as well as in its contact with other equipment, floors, walls or hanging support. With the above principle, materials are commonly used in food processing are Stainless steel, iron and mild steel, copper and its alloys, miscellaneous metal, plastics, rubber, glass and wood, and antimicrobial work surfaces (Forsythe and Hayes, 1998). Manufacturing equipment should be designed to prevent the entry of foreign materials, and the development of ‘out-of-sight dead spots, especially within the operation chamber and associated pipe work. Bolts and clips should be attached externally to maintain all internal product contact surfaces smooth and easily cleaned. For operator safety, all equipment should be made safe by electrical isolation during dismantling and cleaning. Table 3.1. Applications of materials-handling equipments Conveyors Elevators Cranes and hoists Trucks Pneumatic equipments Water flumes Direction Vertical up * * * Vertical down * * * Incline up * * * Incline down * * * * Horizontal * * * Frequency Continuous * * * * Intermittent * * Location served Point * * * * Path * * * Limited area Unlimited area * * Height Overhead * * * * Working height * * * * Floor level * * * * Underfloor * * * Materials Packed * * * * Bulk * * * * * * Solid * * * * * * Liquid * * Service Permanent * * * * * Temporary * * From Brenan et al (1976) in Fellow, P.J. (1990) 3.4.2. Operational Requirements 3.4.2.1. Receiving Raw Material Receiving raw materials should be consider some requirements such as the origin of raw materials, species and size based on product, quality of raw material and end-product. a. Indicators of Fish Freshness On the receiving materials area, sensory analysis is the main method of evaluating fish freshness. It enables differences in texture, flavor, and taste to be determined, and subsequently the usefulness of the raw material. Sensory properties change during storage from the desired very high standard, through neutral or average, and finally to undesirable or disgusting. It is generally assumed that prior to disappearance of desirable features the fish is considered to be fresh, while the appearance of undesirable or disgusting features disqualifies the raw material. The most difficult step is to determine an intermediate state in which the fish is not entirely fresh. Sensory analysis is thus carried out on raw fish and cooked fish. Flavor, appearance and state of abdominal cavity (for not eviscerated fish) are the main indicators of quality in the case of raw fish. For cooked fish, smell is the most important indicator (Hall, 1997). In addition, microbiological test on raw material is important parameter. In raw materials not only use sensory test but also use microbiological test. Particularly, on freshness test of tuna for sashimi, commonly use K value methods. K value is one of chemical methods based on ATP degradation. This method is commonly use on Japan to measure fish freshness. According to Anonymous (2002), checking the following at receipt will confirm seafood safety and freshness: product temperature (chilled seafood should be below 5oC but ideally between -1.5o and 2oC; frozen seafood should be below -18oC), package condition and use-by-date of pre-packaged seafood, hygiene and cleanliness of the transport vehicle, a record of the species, harvest date and location, and suppliers name, and visual quality criteria. Even if quickly frozen after catching, frozen seafood will not keep indefinitely. Bacterial activity ceases below about -10oC, but chemical and biochemical changes (enzymes, oil oxidation, and dehydration) will still occur. These changes may bring about slow irreversible changes in odor, flavor, and appearance. For long term freezer storage, it is recommended that a temperature of -30oC is maintained (this may only be achieved by commercial freezers). Seafood stored at -15oC (domestic freezers) will have a much-reduced shelf life. 3.4.2.2. Handling and Processing Fish and shellfish are considered to be among the most perishable foodstuff. To keep fish cool, packing in ice is used; this methods is avoids the possibility of the temperature dropping to low with the concomitant freezing of the flesh of the fish. During fish handling and processing in fisheries processing, it will retard the fish deterioration. Keeping fish I the cool thus extends the high-quality life (HQL) of the fish. Good chilling practices on board the fishing vessels and on shore result in better quality fish which, on landing (Garthwaite, 1997). Chilling delays and minimizes spoilage and the ideal chilling system cools fish rapidly to wet ice temperatures. It is essential to minimize bacterial contamination of the fish during all stages of handling. Dirt should be washed off the fish as landed and the surfaces with which the fish come in contact be maintained in a clean condition. Care must also be taken to wash the fish after gutting it, and to use clean ice. Fish properly iced will cool rapidly and will retain quality for 1 to 2 weeks, depending on the species. Ease handling, reduction of weight loses, and elimination of bruising are advantages to be considered in short-term storage in refrigerated seawater (Shapton and Shapton, 1991). Since shrimp live only a few minutes after removal from their natural habitat, microbial spoilage starts immediately through marine bacteria on the surface and in the digestive system, and through microorganisms which happen to contaminate the shrimp on the ships deck, in handling, and from iced used during their storage. The prevention of deterioration in the quality of fresh and iced-stored shrimp involves not only maintaining low microbial count but also prevention of oxidation (Shapton and Shapton, 1991). Temperature and time conditions at all steps from catching or harvesting to distribution is important to prevent growth of pathogenic bacteria, histamine producing bacteria and spoilage bacteria. Temperature and time also are important in preventing oxidation and chemical spoilage (Huss, 1994). 3.4.2.3. Additives and chemical materials Additives and chemical material commonly use on fish processing. It usually used on fish value added product. 1. Additives Additives can be divided into six major categories: preservatives, nutritional additives, flavoring agents, coloring agents, texturizing agents, and miscellaneous additives (Branen and Bragerty, 2002). a. Preservatives There are basically three types of preservatives used in foods: antimicrobials, antioxidants, and anti-browning agents. The antimicrobials are used to check or prevent the growth of microorganisms. The antioxidants are used to prevent lipid and/or vitamin oxidation in food products. They vary from natural substances such as vitamins C and E to synthetic chemicals such as butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT). The antioxidants are especially useful in preserving dry and frozen foods for an extended period (Branen and Bragerty, 2002). Anti-browning agents are chemicals used to prevent both enzymatic and non-enzymatic browning in food products, especially dried fruits or vegetables. Vitamin C (E300), citric acid (E330), and sodium sul ¬Ã‚ te (E221) are the most commonly used additives in this category (Branen and Bragerty, 2002). b. Chemical preservatives The action of maximum and minimum limit of chemical curing and preservative agents should be safe usage known (Betty and Diane, 1987). Propionic acid, sorbic acid, benzoic acid and shulphur dioxide are effective as a preservative. Propionic acid and its salts are mould inhibitors. Sorbic acid is useful fungistatic agent for use in flour confectionery, marzipan and cheese. Benzoic acid occurs naturally in cranberries and is added to many other foods. It is more effective against moulds and yeast than bacteria. These compound are most effective at the lowest pH values of food and ineffective at neutral pH. In addition, sulphur dioxide is being effective in inhibiting microbial growth, also helps to maintain the color of vegetable that are going to be processed (Betty and Diane, 1987). Nitrates and nitrites are used as a curing for meats. Due to toxicological concerns there has been a tendency to reduce the concentrations used in recent years. This imparts a red coloration to the meat similar to fresh meat (Betty and Diane, 1987). c. Nutritional Additives Nutritional additives have increased in use in recent years as consumers have become more concerned about and interested in nutrition. Vitamins, which as indicated above are also used in some cases as preservatives, are commonly added to cereals and cereal products to restore nutrients lost in processing or to enhance the overall nutritive value of the food. The addition of vitamin D to milk and of B vitamins to bread has been associated with the prevention of major nutritional deficiencies. Vitamin A, from liver cod, is essential for normal vision, growth, cellular differentiation, reproduction, and integrity of the immune system (Branen and Bragerty, 2002). In addition, Carotenoid on food can be functioned as function not only as color and nutrient compounds but also as antioxidants (Branen and Bragerty, 2002). Carotenoid can help to minimize oxidative damage and reduce the risk for age-related disorders by preventing the accumulation of free radicals (Rosalee and Michael, 2008). In addition carotenoid also found on brown algae (Miyashita and Masashi, 2008) Minerals such as iron and iodine have also been of extreme value in preventing nutritional deficiencies. Proteins or proteinaceous materials such as soya protein also are sometimes used as nutritional additives, although they are most commonly used as texturizing agents. Fiber additives have seen increased popularity in recent years with the increase in consumer interest in dietary fiber. Various cellulose, pectin, and starch derivatives have been used for this purpose. d. Coloring Agents Most coloring agents are used to improve the overall attractiveness of the food. A number of natural and synthetic additives are used to color foods. In addition, sodium nitrite is used not only as an antimicrobial, but also to fix the color of meat by interaction with meat pigments (Branen and Bragerty, 2002). There are two kinds of coloring agents natural coloring and synthetic coloring. Natural coloring made from plants and animals (Table 3.4.). Synthetic coloring made from chemical substances (Table 3.5.). e. Flavoring Agents Flavoring agents comprise the greatest number of additives used in foods. There are three major types of flavoring additives: sweeteners, natural and synthetic flavors, and flavor enhancers (Branen and Bragerty, 2002). Table 3.2. Chemical preservatives and their dose that are allowed for using in food processing (Indonesian Ministry of Health Regulation No. 722/Menkes/Per/IX/88) No Chemical Preservatives Kinds of Food Maximum dose 1 Sulphur dioxide Marmalade Tomato paste Sugar Powder Powder dextrose Sugar Vinegar Syrup Wine Grape Sausage Dried coffee extract Gelatin 100 mg/kg 350 mg/kg 20 mg/kg 70 mg/kg 70 mg/kg 70 mg/kg 70 mg/kg 200 mg/kg 450 mg/kg 150 mg/kg 1 g/kg 500 mg/kg 2 Potassium Bisulphate French fries Frozen shrimp Pineapple essence extract 50 mg/kg 10 mg/kg (raw); 30 mg/kg (cooked) 50 mg/kg 3 Potassium Metabisulphate French fries Frozen shrimp 50 mg/kg 100 mg/kg 4 Potassium nitrate Meat Cheese 500 mg/kg 50 mg/kg 5 Potassium nitrite Meat Corned 125 mg/kg 50 mg/kg 6 Potassium sulphate French fries Frozen shrimp Pineapple essence extract 50 mg/kg 100 mg/kg 500 mg/kg 7 Natrium Bisulphate French fries Frozen shrimp Pineapple essence extract 50 mg/kg 100 mg/kg 500 mg/kg 8 Na-metabisulphate French fries Frozen shrimp 50 mg/kg 100 mg/kg 9 Natrium nitrate Meat Cheese 500 mg/kg 50 mg/kg 10 Natrium nitrite Meat Corned 125 mg/kg 50 mg/kg 11 Natrium sulphate French fries Frozen shrimp Pineapple essence extract 50 mg/kg 100 mg/kg 500 mg/kg (Cahyadi, 2006) The most commonly used sweeteners are sucrose, glucose, fructose, and lactose, with sucrose being the most popular. The most common additives used as sweeteners are low-calorie or non-caloric sweeteners such as saccharin and aspartame. In most cases, flavoring agents are the same chemical mixtures that would naturally provide the flavor (Branen and Bragerty, 2002). f. Texturizing Agents These agents are used to add to or modify the overall texture or mouth feel of food products. Phosphates and dough conditioners are other chemicals that play a major role in modifying food texture. Lecithin and mono- and diglycerides as well as several synthetic derivatives. The primary role of these agents is to allow flavors and oils to be dispersed throughout a food product (Branen and Bragerty, 2002). Stabilizers include several natural gums such as carrageenan as well as natural and modified starches. These additives have been used for several years to provide the desired texture in products such as ice cream and are now also finding use in both dry and liquid products. Carrageenan found in red algae (Yuan, 2008). Phosphates are often used to modify the texture of foods containing protein or starch. These chemicals are especially useful in stabilizing various dairy and meat products. The phosphates apparently react with protein and/or starch and modify the water-holding capacity of these natural food components (Branen and Bragerty, 2002). Benefits of Additives There are obviously many recognized benefits to be derived from additives. Some of the major benefits are a safer and more nutritious food supply, a greater choice of food products, and a lower-priced food supply (Branen and Bragerty, 2002). Risks of Additives The indirect risks that have been described for additives are the converse of some of the benefits attributed to their use. Additives have also resulted in the increased availability of food products with a low density of nutrients. Of greater concern than the indirect risks are the potential direct toxicological effects of additives. Cancer and reproductive problems are of primary concern, although there is no direct evidence linking additive consumption with their occurrence in humans. 2. Chemical Substances Some chemical substances use in fish/food processing. They used on processing area and products. These substance have used based on government regulation. If they not used based on it the product will be danger to consumers. Several chemical substances are used on fish processing: Table 3.3. Organic preservatives and their dose that are allowed for using by Indonesian Government (Indonesian Ministry of Health Regulation No. 722/Menkes/Per/IX/88) No Organic Preservatives Kinds of Food Maximum dose 1 Benzoic acid Soy sauce Soft drink Cucumber pickle Margarine Pineapple essence extract Other foods 600 mg/kg 600 mg/kg 1 g/kg 1 g/kg 1 g/kg 1 g/kg 2 Propionic acid Cheese Bread 3 g/kg 2 g/kg 3 Sorbic acid Cheese 3 g/kg 4 Benzoic Potassium Margarine Pineapple essence extract Dried apricot Jam and jelly Syrup, tomato sauce Grape Other food except meat, fish, fowl 1 g/kg 1 g/kg 500 mg/kg 1 g/kg 1 g/kg 200 mg/kg 1 g/kg 5 Propionic potassium Cheese 3 g/kg 6 Sorbic potassium Cheese Raw cheese Margarine Dried apricot Cucumber pickle Jam and jelly Marmalade Pineapple essence extract 3 g/kg 1 g/kg 1 g/kg 500 mg/kg 1 g/kg 1 g/kg 500 mg/kg 1 g/kg 7 Benzoate Potassium Pineapple essence extract 1 g/kg 8 Methyl-p-hydroxyl benzoic Cucumber pickle Liquid coffee extract Tomato paste, essence Other food except meat, fish, fowl 250 mg/kg 450 mg/kg 1 g/kg 1 g/kg 9 Natrium benzoate Jam and jelly Soy sauce Soft drink Other foods 1 g/kg 600 mg/kg 600 mg/kg 1 g/kg 10 Natrium propionic Look at on propionic acid Look at on propionic acid 11 Nisin Cheese 12.5 mg/kg 12 Propil-p-hydroxyl benzoic Look metal-p-hydroxyl benzoic Look metal-p-hydroxyl benzoic Source: Cahyadi, (2006) Table 3. 4. Natural coloring agents characteristic Group Color Sources Solubility Stability Caramel Brown Cooked sugar Water Stable Anthosianine Orange, Red Blue Plants Water Sensitive to heat and pH Flavonoid Without yellow Plants Water Stable to heat Leucoanthocianine Colorless Plants Water Stable to heat Tannin Colorless Plants Water Stable to heat Bataline Yellow, red Plants Water Sensitive to heat Quinon Yellow-black Lichen Water Stable to heat Xanthon Yellow Plants Water Stable to heat Carotenoid Without yellow and red Plants Water Stable to heat Chlorophyll Green, brown Plants Lipid and Water Sensitive to heat Heme Red, brown Animals Water Sensitive to heat Source: Cahyadi (2006) Tabl