GMP&GHP

GMP- 1Good manufacturing practices are those aspects of quality assurance that ensure that materials and articles are consistently produced and controlled, to ensure they comply with the law and with the quality standards appropriate to their intended use, so that any migration of chemicals does not endanger human health or cause unacceptable changes in the composition of the food or deterioration in its sensory characteristics (food std agency). GMPs are guidance that outline the aspects of production and testing that can impact the quality of a product. Guidelines for GMP follow some basic principles which are follows:- Good manufacturing practices for ice cream industry could be described in detail as follows:- **Building and facilities-** __Location-__ The location of the industry is away from toxic chemical, odour producing industries. The road to the site is concreted or cemented and the surrounding area is clean with no garbage accumulation, stagnant water, not prone to pest infestation and flooding. There is no uncontrolled vegetation at least six feet from building walls. Equipments or utensils which are properly cleaned and stored are used for the preparation of food and storage as well. Open drains, garbage dumps, open spaces, roof tops are strictly prohibited for this purpose. __Design & layout-__ According to GMP requirements the infrastructure is appropriate to the production operations that can be seen in the factory layout, such as the receiving of the dry and liquid raw materials is close and easy for unloading and the cold storage facilities for the raw material such as cream is close to the raw material receiving area and so on. Accordingly it can be seen in the layout that the complete production process and the infrastructure are designed in co-ordination with each other. The entrance for the raw materials and personnel are different; Point no. 25 & 26 show the locker rooms and the entrance for the personnel whereas point nos. 1 & 2 shows the receiving point of the raw materials. In such a way all the other areas are not related or that may facilitate contamination such as toilets/washrooms, eating area are isolated from the processing area, packaging and storage areas. Appropriate loading and unloading area and provision are provided which facilitates movement of material and also provides protection against pest, rain, etc. All requisite “No Objection Certificates” will be obtained from various authorities. __Internal structure and fittings-__ Flooring shall be smooth, impervious, with no crevices or damaged. Floors are constructed to allow adequate drainage. The junctions with walls are covered and cleanable with no sharp edges so easy to clean. The roof of the building is free from gap, water resistance and it prevents the build up of dirt and shedding of particles. The surface of walls and partition is smooth. There is no flaking off of wall paint. There are no crevices for the growth of pests. Windows and ventilators are fitted where ever necessary fitted with cleanable insect proof screen and are easy to clean. The glasses of the windows are shatter proof. Mesh of windows is without any cut to avoid the pest entry. Doors are non absorbent surface, easy to clean and disinfect. Air curtains, wire mesh, doors with the self closing devices are fitted at the entry and exit points. Surface in contact with food is free from cracks, crevices easy to clean and maintain. The internal angels are smooth, non absorbent material, inert to food, detergent and disinfectant. Plastic tubing should be transparent for ease of inspection and cleaning. Tubing must be protected from abrasion or breakage and should be easy to replace. Tubing must be as continuous as possible with couplings kept to a minimum and should be positioned so that no pockets of liquid remain when the tubing is rinsed. Disassembling, cleaning, and sanitizing of tubing, clamps, couplings, and connections must be performed at least after each day’s run and prior to use following extended interruption. __Facilities-__ Water facilities- **GMP**-Adequate supply of potable water for storage, distribution and temperature and any other controls are available. The tanks are situated in such a way that prevent the contamination of water and covered well to prevent the use by animals, birds. Water system for fire control, steam production, refrigeration is not connected to the potable water system. The pipes of the potable are not concealed. **GHP-** Dairy processing establishments should have potable water available, which prior to its first use, should meet the criteria specified by the competent authorities having jurisdiction and should be regularly monitored. Water recirculated for reuse should be treated and maintained in such a condition that no risk to the safety and suitability of food results from its use. Proper maintenance of water conditioning systems is critical to avoid the systems becoming sources of contamination. For example, filter systems can become sources of bacteria and their metabolites if bacteria are allowed to grow on the organic materials that have accumulated on the filter.3 __Drainage and waste disposal-__ The design and construction of the drainage system is appropriate where the sewage meets with the requirement set by the environmental pollution board. The material of the rain water pipes is rust proof whose opening is not in a food processing area. Drains are also made up of rust proof material with adequate trapping device to avoid the entry of pest, which allows the effective cleaning. __Cleaning__ **GMP**-Adequate facilities are provided for utensils and equipment with adequate hot and cold supply of water. Cleaning in place system is used for cleaning of the process lines with proper sanitizers & disinfectant in appropriate proportion set by legislation. CIP is done in three steps or five steps with hot and cold water. It is confirmed that after CIP the lines are clear of disinfectants by passing pigs through the lines with cold water under pressure. After spraying and before commencement of any food processing operation, all food contact surfaces must be thoroughly cleaned and sanitized. Since pesticide regulations are constantly changing, be sure to know the current status of regulations regarding any pesticide used in and around your operation. A person in charge must be assigned the responsibility to supervise the overall sanitation of the facility. The person in charge must ensure that employees working in the food operations are trained in and follow the GMPs.4 **GHP-** Maintenance and cleaning Processing areas should be kept as dry as possible. Use of dry cleaning methods, and limiting the use of water in processing areas, helps to avoid the spread of contamination by water. Wet cleaning (other than Cleaning-in-Place) has been known to lead to milk product contamination due to the production of aerosols. All food product contact surfaces in piping and equipment, including areas that are difficult to clean such as by-pass valves, sampling valves, and overflow siphons in fillers should be adequately cleaned.3 These items cannot be stored in toilet or mechanical rooms. Sufficient volume and water pressure must be available to dislodge particles of filth all surfaces. A high pressure washer is highly recommended. Plumbing systems must be installed and maintained according to law.4 The use of insecticide and rodenticide is permitted only in accordance with manufacturer labelled use and as permitted by state law. Precautions must be taken to prevent the contamination of food or packaging material with illegal residues. Cleaning programmes-A routine programme to verify the adequacy of cleaning should be in place. All equipment and utensils used in processing should, as necessary, be cleaned and disinfected, rinsed with water which is safe and suitable for its intended purpose (unless the manufacturer’s instructions indicate rinsing is not necessary), then drained and air dried where appropriate. Personnel hygiene and toilets- Ample amount of water supply is there in toilets and at wash basins. Taps are non hand operated in order to transfer of contaminants. A hygienic facility for drying the hands is provided. Sanitizers and hand wash are situated at the wash basin. Ventilation- Air borne contamination, humidity affects the safety and suitability of food and are minimised with the adequate ventilation. The areas which release the steam such as pasteurizers, packaging equipment are with the exhaust system. Lighting- Adequate amount of natural and artificial light should be present in all food processing activities. All the lights should be shatter proof so that on breaking of light it won’t contaminate the product. Power back-up- Uninterrupted power supply is provided to the plant for avoiding any break down times in production process this is done with the help of generators & invertors. Storage- **GMP-**Location of the storage facility for all the raw materials is close to the receiving area, on the layout points 3 & 5 are storage facilities & points 1 & 2 are receiving points. **GHP**-Milk storage tanks and cans should be designed, constructed, maintained and used in a manner that will avoid the introduction of contaminants into milk and minimize the growth of micro-organisms in milk. Milk storage equipment should be properly installed, maintained and tested in accordance with manufacturer’s instructions and in accordance with any available technical standards that have been established by appropriate technical standards setting organizations for such equipment (e.g., IDF, ISO, 3A) in order to assist in assuring that the equipment is functioning properly. Surfaces of milk storage tanks, cans and associated equipment intended to come into contact with milk should be easy to clean and disinfect, corrosion resistant and not capable of transferring substances to milk in quantities that will present a health risk to the consumer. Storage tanks and cans should be cleaned and disinfected regularly and with sufficient frequency to minimize or prevent contamination of milk. **Personnel-** A proper ventilation and artificial lighting are provided in toilets. Separate changing facilities for both men and women are provided. Head nets, uniforms, shoes are all provided clean in the changing room. Chewing gums, jewellery, headphones are strictly forbidden in processing areas and nails should be properly trimmed and should not wear any nail polish. Wristwatches, comb, wallets must not be allowed in company. No papers, documents are allowed in clean room, unless these have been specifically approved. No eating, chewing, drinking is allowed in processing area. 11 __Personal Hygiene__ __9__ Provide clear and simple instructions to all staff on personal hygiene (in various languages if necessary) before they start to handle food. Fingernails should be kept clean and short. No nail varnish should be worn. Long hair should be neatly contained with no grips outside the hair covering. If working in a production area it is a requirement to cover hair and beards with a net or snood. Invasive use of perfume or aftershave should not be permitted. __Personal items__ No jewellery should be worn with the exception of plain wedding rings and sleeper earrings.Equally, wrist watches or cufflinks should not be worn in production areas.If other jewellery is worn for medical or religious purposes then a HACCP should be carried out to ensure there is no risk of food contamination from the person working in a particular area. __Protective clothing__ Protective clothing should be restricted for use on site only. It is recommended that clothing should have no external pockets; however where necessary pockets should be restricted to below the waist and should only accommodate items required for work.Contract cleaning of protective clothing should be used to ensure a high standard of cleanliness and employees should be discouraged from home laundering of these garments. In addition to protective clothing and hats, gloves and masks provided for use in open bottle areas may further assist in maintaining integrity of the product. Gloves will only assist in protecting product if they are frequently replaced as needed and clean. A canteen or rest room should be provided for any meal breaks. Smoking materials and foods should not be taken into production areas. 10 Training is provided to all the personnel regarding GMP and GHP. Personnel who works in the processing area should be checked at-least once in a year for communicable infectious diseases. Personnel working in processing area shouldn’t have any open cuts, wounds, contagious diseases, fever, diarrhoea and should high degree of personnel cleans. The hands should be always washed with disinfectant and soap before starting activity, after use of toilets, after touching the contaminated materials and unclean product. Smoking, spitting should not be permitted in processing area. Same procedures for protective clothing and personnel hygiene should be followed by visitors. The language of the personnel hygiene practice should be easily understood by personnel and signs should be used at appropriate places. All the personnel’s in the food industry should be trained for personnel hygiene. Good manufacturing practices in processing line could be carried out as follows, __Receiving-__ **GMP**-When all the raw materials (milk, skim milk powder, saffron, emulsifiers, stabilizers, rose water, cream, sugar) are purchased, adequate records should be kept of incoming lots, which includes date of purchase and source of raw materials used to produce each lot of ice cream. Accurate records can limit product recalls and producer liability in the event of an outbreak. Milk containers must be inspected upon receipt to assure the containers are free of visible filth that may contaminate the milk. Whereas all the bags or the containers of the powdered raw materials should not be damaged or open. **GHP**-Milk should not contain any contaminant at a level that jeopardizes the appropriate level of public health protection, when presented to the consumer**.** The important influence of primary production activities on the safety of milk products, potential microbiological contamination from all sources should be minimized to the greatest extent practicable at this phase of production. It is recognized that microbiological hazards can be introduced both from the farm environment and from the milking animals themselves. Lack of good agricultural, animal feeding and veterinary practices and inadequate general hygiene of milking personnel and equipment and inappropriate milking methods may lead to unacceptable levels of contamination with chemical residues and other contaminants during primary production.Contamination of milk from animal and environmental sources during primary production should be minimized. A contaminant could be any biological and chemical agent, foreign matters or other substances not intentionally added to food which may endanger food safety or suitability. Measures should be implemented at the primary production level to reduce the initial load of pathogenic microorganisms and micro-organisms affecting safety and suitability to the extent possible to provide for a greater margin of safety. The microbial load of milk should be as low as achievable, using good milk production practices, taking into account the technological requirements for subsequent processing. Water and other environmental factors should be managed in a way that minimizes the potential for the transmission, directly or indirectly, of hazards into the milk. Contaminated water, and pests (such as insects and rodents), chemicals and the internal and external environments where the animals are housed and milked, may contaminate feed. Equipment or milking animals’ leads to the introduction of hazards into milk .Water used in primary production operations should be suitable for its intended purpose and should not contribute to the introduction of hazards in milk. This section also covers the activities of personnel involved in the transport of milk. Milk should be collected, transported and delivered without undue delay, and in a manner that avoids the introduction of contaminants into milk and minimizes the growth of micro-organisms in the milk.Personnel and vehicular access to the place of collection should be adequate for the suitable hygienic handling of milk. In particular, access to the place of collection should be clear of manure, silage, etc. Prior to collection, the milk hauler or collection/chilling centre operator should check the individual producer’s milk to ensure that the milk does not present obvious indications of spoilage and deterioration. If the milk shows indications of spoilage and deterioration, it should not be collected. Collection and chilling centres, if employed, should be designed and operated in such a manner that minimizes or prevents the contamination of milk. – Milk should be collected under hygienic conditions to avoid contamination of milk. In particular, the milk hauler or collection centre operator should, where appropriate, take samples in such a way to avoid contamination of the milk and should ensure that the milk has the adequate storage/in-take temperature prior to collection. The milk hauler should receive adequate training in the hygienic handling of raw milk. Milk haulers should wear clean clothing. Milk hauling operations should not be performed by persons at risk of transferring pathogens to milk. Appropriate medical follow-up should be done in the case of an infected worker. Milk haulers should perform their duties in a hygienic manner so that their activities will not result in contamination of milk. – The driver should not enter the stables or other places where animals are kept, or places where there is manure. Drivers clothing and footwear should not be contaminated with manure. Moreover, clothes of the driver should not be soiled and footwear should be changed or cleaned before work is continued. The tanker driver should not enter the processing areas of the dairy plant. Conditions should be arranged in such way to allow necessary communication with the staff of the dairy, delivery of milk samples, dressing, and rest breaks, etc. without direct contact taking place with the dairy processing areas or with staff members involved with processing milk and milk products.3 Microbiological and other specifications 7 Manufacturers should establish incoming milk criteria that take into account the end use of the milk and the conditions under which the milk was produced.Corrective action taken for non-compliance with incoming milk criteria should be commensurate with the potential risks presented by the non-compliance. Incoming milk that is out of compliance with established criteria indicates that the control measure system is not working properly and corrective action should be taken to identify and resolve causative problems. Incoming material (other than milk) requirements Ingredients used for the processing of milk products should be purchased according to specifications, and their compliance with these specifications should be verified. Contaminated ingredients have been known to lead to unsafe/unsuitable milk products, since these ingredients are often added during processing where no further control measures are applied. Preferably, specifications for raw materials should be established such that their use will result in a safe and suitable product. No raw material should be accepted if it is known to contain chemical, physical or microbiological contaminants that would not be reduced to an acceptable level by normal sorting and/or processing. Raw materials should be inspected and sorted before processing. Any claims that raw materials meet safety and suitability specifications should be verified periodically. __Inspection-__ Microbiological analysis of the milk must be done in the quality assurance laboratory and if it is not within the standard limits set by the legislation, the container will be rejected. It can be seen that quality assurance laboratory is close to the receiving section of the raw materials i.e.point no.27. Testing of packaging material is also done in order to check their sustainability to maintain shelf life and quality of ice cream. __Storage of raw material-__ Adequate storage for milk at 4 o C in refrigerated tanks is mandatory to prevent microbial growth. All the powder ingredients such as skim milk powder, emulsifiers and stabilizers are stored in separate rooms at room temperature in low humidity area. Cream is stored at 4 o C in cold room. Packaging material is stored at cool and dry place. Cold storage door plastic curtains are effective where entrance is by forklift. Temporary screens should be tight fitting and constructed in a manner that allows the garage doors to be closed whenever desired. Storage of Equipment, utensils, chemicals not used in ice cream processing must be in an area clearly separated from storage. Poisonous or toxic materials must be stored separately by means of a partition or spacing away from food, equipment, and utensils. If used within the processing area, precautions must be taken to protect all raw ingredients and packaging materials. 4 **GHP-**With consideration given to the end use of the milk, handling, storage and transport of milk should be conducted in a manner that will avoid contamination and minimize any increase in the microbiological load of milk. Any type of direct contact by the personnel working should be avoided with the materials to be used in production process. 6 Proper handling, storage and transport of milk are important elements of the system of controls necessary to produce safe and suitable milk and milk products. Contact with unsanitary equipment and foreign materials are known causes of milk contamination. Temperature abuse is known to increase the microbiological load of milk.3 __Pasteurization-__ **GMP-**This step in the production process is critical for the safety of the product, therefore good manufacturing practice is mandatory to be followed. Temperature and time relationship in pasteurization must be controlled precisely at 175 o C for 25 seconds. This time and temperature relationship for pasteurization reduces the food pathogens. This process step is supposed to be conducted just after the mixing step; in the layout also the pasteurizer is located just after the mix product tanks i.e. point 9. **GHP-** Pasteurizer must be cleaned after every shift or if not used for long time. Pasteurizer should be dismantled and all the plates of the pasteurizer should be cleaned. All parts of pasteurizer should be cleaned with detergent and then rinse with clean water. Then process should be followed by drying and reassemble. __Homogenization-__ **GMP-**Homogenization of the raw product mix is to be carried out in order to make the mix of uniform so the final product is of firm texture. Homogenization is done at 180bar working pressure and the location of the homogenizer is after the pasteurizer at point no 10 in the layout. GHP- All parts of homogeniser are separated and disinfected with the detergent. Keep using the homogeniser with the leakage may contaminate the mix so that is not the GMP and GHP. So proper maintenance and periodic checking should be done. Ageing- In ice cream production ageing is one of the most important step, in this step the matrix that is required for producing ice cream is formed, where fat, sugar, ice, protein, etc form the matrix. Ageing is supposed to be done minimum for 4 hours & at 0 to 4 o C. The homogenized mix is then transferred through pipe line to the mix storage tanks which are refrigerated tanks to maintain the temperature. The tanks are situated at point 15 in the layout. GHP- Cleaning of tanks after every batch with disinfectant. There should not be overfilling of tanks. Tanks should always be covered with lids on order to avoid entry of foreign material into mix. Fouling at the outlet of the tank could occur due to improper cleaning of tanks. __Freezing-__ GMP-In this stage the aged ice cream mix is developed into ice cream by continuous mixing and incorporation of clean air in the mix at 0 o C for 15seconds in continuous freezer. The air incorporated in the mix must be clean therefore the air is filtered, so that there are no chances of contamination of the mix due to air. The freezers are located immediately after the ageing tanks at point no. 16 and just before fillers point no. 17 in the layout it can be seen. GHP- Air filters should be cleaned properly. Machine used for freezing and developing mix into the ice cream needs to be clean and maintained. __Packaging-__ GMP-The fillers for the packaging of the produced ice cream is next to the freezers where ice cream is produced i.e. at point 16 and is filled at point 17 by the fillers. Packaging is supposed to be done immediately or else the ice cream will not acquire the shape of the package. GHP-According to the good manufacturing practices, the packaging material used to pack the ice cream must be clean, free from dust, dirt, moisture, or any type foreign material. Also care must be taken that the filler machine /equipment is clean and is cleaned after ever shift or product change and also it should be leak proof. __Hardening & Storage-__ **GMP-**When packed ice cream is passing through hardening tunnel, temperature should be maintained at -30 to -40 o C. Nevertheless, the temperature at hardening room needs to be maintained at -25 o C. Strong refrigeration system maintains the temperature of the hardening tunnel at -30 to -40 o C. The refrigeration system is periodically checked for problems and the control board is continuously monitored by a trained operator. Backup is provided for the refrigeration system so in case of break down the temperature won’t fall and the product remains safe. __Equipments:__- **GHP-**Milk transport tankers, milk storage tanks and cans should be designed, constructed, maintained and used in a manner that will avoid the introduction of contaminants into milk and minimize the growth of micro-organisms in milk as well.3 Milk transport tankers, milk storage tanks and cans should be designed and constructed such that they can be effectively cleaned and disinfected. Milk transport tankers, milk storage tanks and cans should be designed and constructed to ensure complete drainage. Milk transport tankers and cans should not be used to transport any harmful substance. If milk transport tanks and cans are used to transport foods other than milk, precautions such as the implementation of adequate cleaning protocols should be taken to prevent any subsequent milk contamination. Surfaces of milk transport tankers, milk storage tanks and cans associated equipment intended to come into contact with milk should be easy to clean and disinfect, corrosion resistant and not capable of transferring substances to the milk in such quantities as to present a health risk to the consumer. Milk cans, storage tanks, transport tankers (including the milk discharge area, valves, etc.) should be cleaned and disinfected with sufficient frequency in order to minimize or prevent contamination of milk. After disinfection, tankers and cans should be drained. Lorries, trucks or other vehicles which carry the tank or cans should be cleaned whenever necessary. __Documentation and record keeping__ There need to be top-level policy documents setting out the organisation’s approach to such topics as validation, cleaning and full SOPs for the operation of all facilities, equipment and systems. All steps in the manufacture and testing need full records. This is often done by the use of predesigned and authorised forms to collect analytical data. However, especially at the very beginning of development, changes are so frequent that pre-prepared forms may not be feasible. Laboratory notebooks must be used to collect data. Staff must be trained to know what must be included in books. Another document needed during development is specification. Specifications are necessary for raw material, critical intermediates in the process, finished product. 5Records should be kept, as necessary, to enhance the ability to verify the effectiveness of the control systems.3 __Specific process steps-__ **GHP-**Extrinsic factors refer to factors impacting the product from the environment in which the food is placed. Examples include temperature, time, and relative humidity of the air. Intrinsic factors refer to internal factors in the product itself (food matrix), influenced by or as consequence of extrinsic factors, that have an impact on the growth and/or survival of micro-organisms. Examples include water activity, pH, nutrient availability, competition of micro-organisms, and bacteriocins or other growth inhibitors. 8 References- 1.Food Standards Agency, June 2009, Guide to legal compliance and practice for business documentation materials and articles in contact with food, Available from- [] 2. [] 3. Code of hygiene practices 4. Article of apple cider 5. GMP for investigational medicinal 6. Code of Hygienic Practice for the Transport of Foodstuffs in Bulk and Semi-Packed Foodstuffs. (CAC/RCP 47 – 2001). Recommended International Code of Practice – General Principles of Food Hygiene, CAC/RCP 1-1969 7. Principles for the Establishment and Application of Microbiological Criteria for Foods, CAC/GL 21-1997 Guidelines for the Conduct of Microbiological Risk Assessment, CAC/GL 30-1999. 8. CODE OF HYGIENIC PRACTICE FOR MILK AND MILK PRODUCTS, CAC/RCP 57-2004 9. Industry Guide to Good Hygiene Practice – Milk and Dairy Products 10. http://www.food.gov.uk/foodindustry/guidancenotes/ hygguid/foodhandlersguide
 * Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.
 * Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the food are validated as necessary.
 * Instructions and procedures are written in clear and unambiguous language
 * Operators are trained to carry out and document procedures.
 * Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food was as expected. Deviations are investigated and documented.2

11. J. Sharp (ED), Guide to good manufacturing practices (Intro.), HMSO, London, 1983.