National Standards of the People's Republic of China
gb 12693-2023
National standards for food safetyGood Manufacturing Practices for Dairy Products
Foreword
This standard replaces GB 12693-2010 National Food Safety Standard Good Manufacturing Practices for Dairy Products.
The main changes in this standard compared to GB 12693-2010 are as follows:
The terms and definitions of "clean work area", "quasi-clean work area" and "general work area" have been deleted
The technical requirements and monitoring requirements of sterilization equipment have been increased
The equipment and facilities have increased the requirements for the reliability control of the automated storage system
The control requirements for the storage temperature of raw milk after entering the plant have been increased
The "special technical requirements for different dairy production processes" has been added, and the recommended requirements for the monitoring of microorganisms in the production and processing processes of different dairy products have been refined
Training requirements for sterilization operators, liquid product filling and sealing operators, cleaning and disinfection personnel have been added.
Scope
This standard stipulates the basic requirements and management guidelines for the premises, facilities, and personnel in the procurement, processing, packaging, storage and transportation of raw materials in the production process of dairy products.
This standard applies to the production of dairy products processed with raw milk and its processed products as the main raw materials.
Terms and Definitions
The terms and definitions defined in GB 14881 apply to this standard.
Site selection and factory environment
It should comply with the relevant provisions of GB 14881.
Plants and workshops
4.1 Basic requirements.
It should comply with the relevant provisions of GB 14881.
4.2. Partitioning requirements for operation areas.
4.2.1. According to the product characteristics, production process and the requirements of the production process for cleanliness, combined with the actual situation of the plant and workshop, reasonable partitioning should be carried out,-- and the plant and workshop should be divided into general operation area, quasi-clean operation area and clean operation area.
4.2.2. The general operation area includes milk collection room, raw material warehouse, packaging material warehouse, outer packaging workshop, post-sterilization room for filling and sterilization process, finished product warehouse, etc.
4.2.3. The quasi-clean operation area includes the workshop for raw material pretreatment, weighing, blending, and temporary storage of primary packaging materials with subsequent sterilization or sterilization processes.
4.2.4. The cleaning operation area includes the workshop where the weighing, batching, filling, etc. are in contact with the air environment and there is no subsequent sterilization or sterilization process, the auxiliary area with special cleaning requirements (such as the temporary storage room for the bare inner packaging after temporary cleaning and disinfection, etc.), and the inner packaging workshop where the semi-finished products to be packaged are stored, filled and in contact with the air environment without subsequent sterilization.
Facilities & Equipment
5.1 Basic requirements.
It should comply with the relevant provisions of GB 14881.
5.2 facilities.
5.2.1. Water supply facilities.
Safety and sanitation facilities should be added at the entrances and exits of water supply facilities to prevent food contamination caused by the entry of animals and other foreign objects.
5.2.2. Drainage facilities.
5.2.2.1. Drainage facilities should have slopes, keep them smooth, easy to clean, and the joints of the side and bottom of the drainage ditch should have a certain arc or take corresponding measures to prevent the generation of water accumulation. The drainage facilities in the operation area should avoid the reverse flow of the sewer and the escape of turbid gas, and if necessary, the floor drain with water seal or check valve or backflow prevention should be used.
5.2.2.2. There should be no water supply pipeline for production water under the drainage facilities.
5.2.3 personal hygiene facilities.
5.2.3.1. Changing rooms (including changing shoes or wearing shoe covers), hand-washing and drying facilities, and disinfection facilities should be set up near the entrance of the production site or production workshop.
5.2.3.2. Personnel should have necessary cleaning measures before entering the cleaning area, and a special locker room should be set up at the entrance of personnel. Hand disinfection facilities are set up before entering the cleaning area, and hand washing facilities are not required.
5.2.4. Ventilation facilities.
5.2.4.1. Effective measures should be taken to prevent animals or other foreign objects from entering the outdoor air inlet, keep away from pollution sources and exhaust ports, and be equipped with air filtration equipment. The exhaust port should be fitted with an easy-to-clean, corrosion-resistant grille to prevent animal intrusion.
5.2.4.2. Compressed air or other gases used for food production, cleaning food contact surfaces and equipment should be filtered and purified to prevent indirect contamination.
5.2.4.3. In areas where there are peculiar smells and gases (vapors and harmful gases) or dust that may contaminate food, there should be appropriate elimination, collection or control devices.
5.2.4.4. A purification air conditioning system should be installed in the clean operation area to prevent steam condensation and keep the indoor air freshVentilation facilities should be installed in the general operation area or ensure good ventilation, and remove damp and dirty air in time. When air conditioning, air intake and exhaust or fan use in the factory should flow from the area with high cleanliness requirements to the area with low cleanliness requirements to prevent contamination of food, production equipment and inner packaging materials.
The pressure difference between the clean work area and the general work area should be maintained at a positive pressure of more than 10 Pa.
5.2.5. Storage facilities.
5.2.5.1. When the automated warehouse stores items with different properties in the same warehouse, effective control measures should be established for the reliability of the automation system.
5.2.5.2. The refrigerated (frozen) warehouse should be equipped with a thermometer, a thermostat or an automatic temperature recorder that can correctly indicate the temperature in the warehouse, and the temperature should be monitored and recorded, and the monitoring frequency should be in line with the characteristics of the stored products. Thermometers, thermometers, or automatic temperature loggers should be calibrated regularly.
5.3 equipment.
5.3.1. Production equipment.
5.3.1.1Storage, transportation and processing systems (including gravity, pneumatic, airtight and automatic systems) should be designed and manufactured in such a way as to be easy to maintain in good hygienic condition.
5.3.1.2. There should be a special area for storing equipment spare parts and necessary maintenance tools, so that the necessary spare parts can be obtained in time when the equipment is maintained.
The storage area for spare parts and maintenance equipment should be kept clean and dry.
5.3.1.3. In the production process, all kinds of thermal sterilization equipment should meet the requirements of the sterilization process, and there should be an automatic alarm device for abnormal conditions. After the sterilization equipment is installed, the sterilization effect should be verified, and the sterilization effect can be put into use only after confirming that the sterilization effect meets the process requirements. If there is a change in the structure, pipeline, valve, and sterilization control program of the sterilization equipment, or if necessary, the sterilization effect should be verified again. The sterilization equipment should be verified regularly to ensure the reliability of the sterilization performance. The sterilization equipment for sterilization after filling should be tested for heat distribution to confirm that the heat distribution is uniform. Aseptic filling (including sterilization) equipment should verify the effectiveness of the product to achieve commercial sterility.
5.3.2. Monitoring equipment.
When computer systems and their network technologies are used for the collection of critical control point monitoring data and the management of records, the relevant functions of computer systems and their network technologies can be referred to in Appendix A.
5.3.3. Maintenance and repair of equipment.
Before each production, check whether the equipment is in a normal state to prevent the occurrence of situations that affect the hygienic quality of the productIn case of failure, it should be eliminated in time and the time of failure should be recorded. The cause and the potentially affected product batches. Establish the maintenance of processing equipment and implement it as planned.
Hygiene management
6.1 Basic requirements.
It should comply with the relevant provisions of GB 14881.
6.2. Facility hygiene management.
Removable equipment and utensils that have been cleaned and disinfected should be placed in a dedicated place and their food contact surfaces should not be contaminated.
Food raw materials, food additives and food-related products
7.1 Basic requirements.
Food raw materials, food additives and food-related products shall comply with the relevant provisions of GB 14881.
7.2. Food raw materials.
7.2.1. A first-class business management system should be established to stipulate the selection, review and evaluation procedures of first-class businessmen. Raw milk purchasing stations or pastures should comply with relevant national and local regulations, carry out unified management of the whole process of raw milk quality and safety, and strengthen the construction of milk source bases.
7.2.2. Enterprises using raw milk should inspect batch by batch in accordance with relevant national regulations, record the inspection situation, the name of the supplier and the date of purchase, etc., and inspect the transport vehicles and make a record of the raw milk.
7.2.3. The raw materials and packaging materials that are judged to be unqualified shall be identified, stored separately, notified to the supplier, and properly disposed of.
7.2.4. The transportation and storage of raw milk should meet the following requirements.
a) Containers for the transport and storage of raw milk shall comply with relevant national standards. Insulated milk tanks or milk storage containers for transporting raw milk should be cleaned every time, disinfected regularly, and free of milk scale and odor. Enterprises should establish an inspection mechanism.
b) Relevant records should be checked to confirm that the raw milk is cooled to 0 4 within 2 h after **. The storage and transportation of raw milk should comply with the relevant regulations and relevant standards of the relevant state departments, and the temperature should be effectively controlled, protected, and the temperature should be monitored and recorded.
c) raw milk to the factory should be processed in a timely manner, if can not be processed in time, should be refrigerated storage, no special requirements, storage temperature does not exceed 7, while the temperature and microbial pollution degree monitoring, do a good record.
7.3. Other raw materials.
7.3.1. In the process of transportation and storage, raw materials and packaging materials should be avoided from being polluted and damaged, and the deterioration of quality should be minimizedRaw materials and packaging materials with temperature, humidity and other special requirements should be transported and stored according to the specified conditions.
7.3.2. During the storage period, it should be stored in different areas according to the characteristics of different raw materials and packaging materials, and a logo should be established to indicate the relevant information and quality status.
7.3.3. Inventory raw materials and packaging materials should be regularly inspected, and the raw materials and packaging materials that are stored for a long time and the quality is easy to change should be sampled to confirm the quality before useClean up raw materials and packaging materials that have deteriorated or exceeded their shelf life in a timely manner.
Food safety control of the production process
8.1 Basic requirements.
8.1.1 Subject to GB 14881.
8.1.2. The relevant principles of hazard analysis and critical control points should be followed, a strict food safety control system should be established and effectively operated, the key links of food safety in the production process should be clarified, and control measures for key links of food safety should be formulated.
8.1.3. The temperature and humidity facilities in the clean operation area of the production of powdered dairy products should be adjustable, and monitoring devices should be set up.
8.1.4. Before forming an independent packaging of products, effective temperature and time control measures should be formulated according to product characteristics and process requirements, and the basic requirements are as follows.
a) Specify methods for killing microorganisms or inhibiting the growth and reproduction of microorganisms, such as heat treatment, freezing or refrigeration, etc., and implement effective monitoring.
b) Establish temperature, time control measures and deviation correction measures, and conduct regular verification.
c) Real-time monitoring measures should be formulated for the processing links with strict control of temperature and time, and monitoring records should be kept.
8.1.5. According to the characteristics of the product and process, the air humidity in the area where humidity control is required should be controlled to reduce the reproduction of harmful microorganismsEstablish air humidity limits and enforce them effectively. If necessary, real-time air humidity control and monitoring measures are developed, verified on a regular basis, and recorded.
8.1.6. The air cleanliness requirements of the production area should meet the following requirements.
a) The production workshop should keep the air clean to prevent contamination of food.
b) The number of sedimentation bacteria in the air in the cleaning operation area of pasteurized milk and processed cheese should be 100 cfu dishes (dynamic) (measured according to GB T 16294 for 4 hours), and the number of sedimentation bacteria in the air of other dairy products cleaning operation areas should be 100 CFU dishes (dynamic) (measured according to GB T 16294 for 1 h). The number of sedimented bacteria in the air in the quasi-clean operation area should be 50CFU dish (measured according to GB T 16294 for 5 min).
8.1.7. For the aseptic filling equipment with its own purification function placed in the quasi-clean operation area and using the integrated equipment of blowing, filling, capping (sealing) and the aseptic filling equipment with its own safety protection function, the positive pressure protection should be monitored to ensure the effective maintenance of the internal clean environment in productionThe repair and maintenance of the equipment should be carried out during non-production hours, and the sterile environment should be re-established before production.
8.1.8. Strict hygiene control requirements should be formulated for raw materials, packaging materials and personnel entering the clean operation area.
8.1.9 For different dairy products, microbial monitoring procedures for processing can be established with reference to Appendix B.
8.2. Special technical requirements for the production process of different dairy products.
8.2.1 pasteurized milk.
8.2.1.1. Enterprises should verify the effectiveness of the pasteurization process, monitor the temperature in the pasteurization process, and have an automatic alarm device when there is an abnormality. The effectiveness of the membrane filtration sterilization system should be verified by the process of membrane filtration sterilization combined with pasteurization.
8.2.1.2. After sterilization, semi-finished products should be protected by positive pressure by using sterile air in the storage tank.
8.2.1.3. The safety evaluation of the sterilization effect should be carried out to verify the sterilization parameters, and control measures and disposal measures should be established.
8.2.1.4. See Table B1. The requirements of establishing microbial monitoring procedures for pasteurized milk processing processes, including sampling points, monitoring frequency, sampling and testing methods, evaluation principles and corrective measures.
8.2.1.5. After filling, the product should be sealed (flexible packaging) or sealed (hard packaging such as glass jars) test.
8.2.2. Sterilized milk.
8.2.2.1. Cleaning, disinfection and sterilization of product processing equipment.
8.2.2.1.1. In the aseptic filling process, high-temperature pressurized water, filtered steam, sterile distilled water or other suitable treatment agents should be used before production to clean and sterilize all pipelines, valves, pumps, buffer tanks, filling equipment and other product contact surfaces downstream of the product and the pipeline. UHT milk processing should ensure that all surfaces in direct contact with the product meet the requirements for aseptic filling after sterilization and remain in this state until the end of production.
8.2.2.1.2. The azile warehouse of the filling and packaging equipment in the aseptic filling process should be cleaned and sterilized, and the production requirements of aseptic filling should be met before the product starts filling, and the state should be maintained until the end of production. Key indicators such as time, temperature, and disinfectant concentration should be monitored and recorded during the sterilization process, and verification measures should be established for the sterilization effect.
8.2.2.1.3. The cleaning and disinfection of the processing equipment of the sterilization process after filling should meet the process requirements.
8.2.2.2. Thermal sterilization of products.
8.2.2.2.1. Sterilization process procedures should be formulated and verified to ensure that the requirements of commercial sterility are met. When formulating the sterilization process specification, the following key influencing factors of thermal sterilization should be considered: the type of sterilization equipment, the characteristics of food, the type and size of the container, the technical and hygienic conditions, the water activity, etc. When the technical conditions of the product are changed, it should be analyzed and evaluated whether it has an impact on the sterilization effect. If it is found that the original sterilization process is no longer applicable, the sterilization process specification should be reformulated.
8.2.2.2.2. Sterilization operating procedures should be formulated and strictly implemented. If there is a deviation in the sterilization process, the deviation should be corrected according to the correction plan, and the product should be isolated, the cause should be identified, and the corrective measures should be proposed.
8.2.2.2.3. The product should be tested for commercial sterility to determine whether it meets the requirements of commercial sterility. If the batch does not meet the requirements for commercial sterility, it should be properly disposed of in accordance with the relevant regulations. The judgment process, results and processing methods should be recorded.
8.2.2.3. Filling of products.
8.2.2.3.1. Automatic mechanical devices should be used and should not be operated manually.
8.2.2.3.2. For sterilized products after filling, the time from sealing to sterilization should be controlled within the time range required by the process regulations.
8.2.2.3.3. After filling, the product sealing or sealing test should be carried out.
8.2.3. Fermented milk.
8.2.3.1. The temperature during the sterilization process of fermented milk should be monitored.
8.2.3.2. The strains used for fermentation should comply with the corresponding regulations.
8.2.3.3. Sterilized process products and other materials that need to be added (such as bacteria, jam and other non-re-sterilized materials) in the storage tank (or aseptic bag) should be protected by sterile air, nitrogen or inert gas in the storage tank (or aseptic bag).
8.2.3.4. After the material is sterilized, the water in contact with it should be sterilized or sterilized.
8.2.3.5. Before production, high-temperature pressurized water, filtered steam, sterile distilled water or other suitable treatment agents should be used to clean and sterilize all pipelines, valves, pumps, buffer tanks, filling equipment and other product contact surfaces downstream of the product at high temperature and downstream of the pipeline.
8.2.3.6. For products without sterilization process after fermentation, please refer to Table B2. The requirements of the establishment of microbial monitoring procedures for the subsequent fermented milk processing process without sterilization process, including microbial monitoring indicators, sampling points, monitoring frequency, sampling and testing methods, evaluation principles and corrective measures.
8.2.3.7. After filling, the product sealing or sealing test should be carried out.
8.2.3.8. Each batch of products should be sampled and tested according to the level of product safety and quality control, and a reasonable sampling and insulation scheme should be designed according to the characteristics of the product, and evaluation and control measures should be established.
8.2.4. Milk powder.
8.2.4.1. Heat treatment.
Pasteurization and other sterilization treatments should be carried out before spray drying, and the heat treatment process should be used as a key control point to ensure the safety of dairy products in wet and dry-wet composite production processes. The heat treatment temperature and time should consider the influence of product attributes and other factors (such as fat content, total solids content, etc.) on the heat resistance of the target microorganisms. Control measures and deviation correction measures for heat treatment temperature and time should be established, monitored in real time, and corresponding monitoring records should be kept.
8.2.4.2. Intermediate storage.
In the wet and dry and wet composite production processes, corresponding measures should be taken to prevent the growth of microorganisms for the intermediate storage of liquid semi-finished products. Raw material powders exposed in dry production or powdered semi-finished products exposed in wet production should be stored in a clean work area if they need to be temporarily stored. If the powdered semi-finished products are placed outside the cleaning area, they should be protected by strict safety and ensure that the necessary cleaning measures are necessary to meet the requirements of the cleaning operation area when they enter the cleaning area again.
8.2.4.3. Cool.
In wet and wet and dry combined production processes, fluidized beds and other facilities can be used for cooling to prevent product contamination during the cooling process.
8.2.4.4. Dry mix.
8.2.4.4.1. The bare powder process in contact with the ambient air (such as feeding, batching, mixing and filling of the dry mixing process) should be carried out in the clean operation area. The temperature and relative humidity of the clean work area should be adapted to the dairy production process.
8.2.4.4.2. It should be fed according to the requirements of the product formula ratio and ensure accurate measurement.
8.2.4.4.3. The key process parameters related to the mixing uniformity (such as mixing time, etc.) should be verified, and the uniformity of the mixing should be confirmed.
8.2.4.4.4. For raw materials or products transported through air pipelines into the clean operation area, appropriate air filtration systems should be designed and installed.
8.2.4.4.5. For key processing parameters, corresponding control measures should be established.
8.2.4.5. Inner packing.
8.2.4.5.1. The inner packaging process should be carried out in the clean operation area, and the packaging materials entering the clean operation area should have cleaning measures.
8.2.4.5.2. Effective foreign body control measures should be adopted to prevent and inspect foreign bodies, and process monitoring and effectiveness verification should be implemented.
8.2.4.6 See Table B3. The requirements for the establishment of microbial monitoring procedures for the milk powder processing process, including microbial monitoring indicators, sampling points, monitoring frequency, sampling and testing methods, evaluation principles and corrective measures.
8.2.5. Processed cheese:
8.2.5.1. The raw cheese before the ingredients after cutting should be properly stored and should be refrigerated and stored at 6 and below. The storage temperature should be monitored and used within the specified time.
8.2.5.2. The sterilization process regulations should be strictly implemented, and if the continuous sterilization process is adopted, it is advisable to have an automatic recorder for continuous monitoring and recording, and be equipped with an alarm device, when the temperature or time deviates from the set value, it should be corrected in time.
8.2.5.3 See Table B4. The requirements for the establishment of microbial monitoring procedures for the processing process of processed cheese, including microbial monitoring indicators, sampling points, monitoring frequency, sampling and testing methods, evaluation principles and corrective measures.
8.2.5.4. After filling, the product should be tested for sealing quality.
Inspection
It should comply with the relevant provisions of GB 14881.
Storage and transportation of foodstuffs
10.1 Subject to GB 14881.
10.2. For dairy products that need to be refrigerated and frozen, the temperature requirements for product storage and transportation should be clearly stipulated.
Product recall management
It should comply with the relevant provisions of GB 14881.
Training
12.1 Subject to GB 14881.
12.2. Respond to the operation skills training of key positions such as sterilization operators, liquid product filling and sealing operators, cleaning and disinfection personnel, formulate training plans and ensure effective implementation.
Management system and personnel
It should comply with the relevant provisions of GB 14881.
Records and document management
It should comply with the relevant provisions of GB 14881.
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