Some standard content:
GB 17405--1998
In the preparation of this standard, some of the contents of the "China Good Manufacturing Practice for Pharmaceuticals" (revised in 1992) on clean workshops were adopted. In terms of the format and content, the "Good Manufacturing Practice for Pharmaceuticals" of the World Health Organization (WHO) was referred to. In terms of general building design and sanitation requirements, GB14881-1994 "General Hygiene Standards for Food Enterprises" was referred to. Since this standard belongs to the scope of food production, the requirements for employees, building facilities and document retention are lower than those of the Good Manufacturing Practice for Pharmaceuticals, but higher than the "General Hygiene Standards for Food Factories". In the formulation of this standard, the Hazard Analysis Critical Control Point (HACCP) principle was fully referred to, and specific requirements were put forward in some key links.
This standard was proposed by the Ministry of Health of the People's Republic of China. This standard was drafted by the Food Sanitation Supervision and Inspection Institute of the Ministry of Health; Fujian Food Sanitation Supervision and Inspection Institute, Guangdong Food Sanitation Supervision and Inspection Institute, Liaoning Food Sanitation Supervision and Inspection Institute, Shenyang Health and Epidemic Prevention Station, Tianjin Health and Disease Prevention Center, and Fujian Fulong Biological Products Co., Ltd. participated in the drafting.
The main drafters of this standard are Bao Dayue, Li Tairan, Lin Shengqing, Zhang Yonghui, Shi Gensheng, Xiao Dongsheng, Liu Changhui, Liu Hongde, Zheng Pengran and Sheng Wei.
This standard is entrusted by the Ministry of Health to the Ministry of Health Food Hygiene Supervision and Inspection Institute for interpretation. 718
1 Scope
National Standard of the People's Republic of China
Good Manufacturing Practice for Health Food
Good manufacture practice for health food GB17405—1998
This standard specifies the basic technical requirements for personnel, design and facilities, raw materials, production process, storage and transportation of finished products, and quality and hygiene management for enterprises producing foods with specific health functions. This standard applies to all health food production enterprises. 2 Referenced Standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard is published, the versions shown are valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest versions of the following standards. GBJ73-84 Cleanroom Design Specifications
GB5749-85 Sanitary Standards for Drinking Water GB7718-94 General Standards for Food Labeling
GB14881-94 General Sanitary Specifications for Food Enterprises 3 Definitions
This standard adopts the following definitions.
3.1 Raw Materials
All inputs used in the production process of health foods, including processing aids and food additives. 3.2 Intermediate Products
Substances or mixtures that require further processing. 3.3 Products
Finished products to be sold after being formed into fixed packages. 3.4 Batch Number
A group of numbers or letters and numbers used to identify a "batch". It can be used to trace and review the production history of the batch of health foods. 4 Personnel
4.1 Health food production enterprises must have technical personnel with relevant professional knowledge in medicine (or biology, food science) and management personnel with production and organizational capabilities that are suitable for the health foods they produce. The proportion of full-time technical personnel should not be less than 5% of the total number of employees.
4.2 The person in charge of technology must have a college degree or above or a corresponding degree, and have experience in health food production and quality and hygiene management.
4.3 The person in charge of the health food production and quality management department must be a full-time staff member, who should have a college degree or above or a corresponding degree suitable for the profession he is engaged in, be able to organize production or conduct quality management in accordance with the requirements of this specification, and have the ability to make correct judgments and handle practical problems arising in health food production and quality management. Approved by the Ministry of Health of the People's Republic of China on May 5, 1998, and implemented on January 1, 1999
GB17405—1998
4.4 Health food production enterprises must have full-time quality inspection personnel. Quality inspection personnel must have a secondary technical school degree or above; purchasing personnel should have the knowledge and skills to identify whether the raw materials meet the quality and hygiene requirements. 4.5 Before taking up their posts, employees must receive health law education and relevant technical training. Enterprises should establish training and assessment files. The heads of enterprises and heads of production and quality management departments should also receive professional training on health food from health supervision departments at or above the provincial level and obtain qualification certificates.
4.6 Employees must undergo a health check-up and can only take up their posts after obtaining a health certificate. They must undergo a health check-up once a year thereafter. 4.7 Employees must maintain personal hygiene in accordance with the requirements of GB14881. 5 Design and facilities
5.1 Design
The overall design of the health food factory, the general design of the plant and facilities, the buildings and sanitary facilities shall comply with the requirements of GB14881. 5.2 Plant and plant facilities
5.2.1 The plant should be reasonably laid out according to the production process and the required cleanliness level. The various production operations in the same plant and adjacent plants shall not interfere with each other.
5.2.2 Cleanliness levels must be divided according to production processes and health and quality requirements. In principle, they are divided into general production areas and 100,000-level areas. Corresponding purification and air conditioning facilities with filtering devices should be installed in 100,000-level cleanliness areas. See Table 1 for cleanliness levels and ventilation times of workshops. Table 1
Cleanliness levels
10000-level
100000-level
≥0.5 μm
3500000
Dust count/m3
≥5 μm
N20000
5.2.3 The design and installation of clean workshops shall comply with the requirements of GBJ73. Number of viable microorganisms/m3
Air changes/h
≥20 times
≥15 times
5.2.4 The purification level must meet the needs of air purification for the production and processing of health foods. The production of tablets, capsules, pills and oral liquids that cannot be sterilized in the final container should use a 100,000-level clean workshop. 5.2.5 The layout of the workshop, equipment and process flow should be reasonably connected, the building structure should be perfect, and it should meet the requirements of production process, quality and hygiene; the workshop should have enough space and place to place equipment and materials; the storage room for intermediate products and products to be packaged should be adapted to production requirements.
5.2.6 The temperature and relative humidity of the clean workshop should be adapted to the production process requirements. 5.2.7 The sewers, hand washing and other sanitary cleaning facilities installed in the clean workshop shall not cause pollution to the production of health foods. 5.2.8 There should be buffer facilities between workshops of different clean levels and between workshops and passages. Personnel and material passages corresponding to the cleanliness level should be set up separately.
5.2.9 The pretreatment of raw materials (such as extraction, concentration, etc.) should be carried out in places that are suitable for its production scale and process requirements, and equipped with necessary ventilation, dust removal and cooling facilities. The pretreatment of raw materials shall not be used in the same production plant as the production of finished products. 5.2.10 The production of health food shall be equipped with a preparation room, and the cleanliness level of the preparation room shall be consistent with the production process requirements. 5.2.11 The air purification facilities and equipment of the clean workshop shall be regularly inspected and maintained, and appropriate measures shall be taken during the inspection and maintenance process to avoid pollution to the production of health food.
5.2.12 The production of fermented products shall have a special fermentation workshop, and there shall be special equipment corresponding to fermentation and spraying. 5.2.13 All production tools and equipment that are in direct contact with raw materials and intermediate products shall be made of materials that meet product quality and hygiene requirements. 6 Raw materials
6.1 The purchase and use of raw materials required for the production of health foods should be subject to acceptance, storage, use, and inspection systems, and a dedicated person should be responsible. 720
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6.2 Raw materials must meet food hygiene requirements. The variety, source, specification, and quality of raw materials should be consistent with the approved formula and product enterprise standards.
6.3 When purchasing raw materials, a valid inspection report must be obtained in accordance with relevant regulations: Raw materials that are new food resources must obtain the Ministry of Health approval certificate (copy).
6.4 Mycelium or a mixture of mycelium and fermentation products obtained by artificial fermentation of fungi and microecological raw materials must be required to obtain a strain identification report, stability report, and certification that the strain does not contain drug resistance factors. 6.5 When using algae, animals, animal tissues and organs as raw materials, a variety identification report must be obtained. For single effective substances extracted from animals or plants or raw materials made from biological or chemical synthesis, the physical and chemical properties and content test reports of the substances should be requested. 6.6 For raw materials containing stimulants or hormones, the content test report should be requested; for raw materials that have been irradiated, the relevant information on the irradiation dose should be requested.
6.7. The transportation tools of raw materials shall meet the hygienic requirements. According to the characteristics of raw materials, corresponding facilities such as heat preservation, refrigeration, preservation, rain and dust prevention shall be equipped to ensure quality and hygienic needs. During transportation, raw materials shall not be mixed with toxic and harmful items in the same vehicle or container. 6.8. After the purchase of raw materials, the source, specifications and packaging shall be preliminarily checked, and the warehouse account and card shall be filled in according to the provisions of the acceptance system. After entering the warehouse, the quality inspection department shall be applied for sampling inspection.
6.9. Various raw materials shall be stored off the ground according to the waiting, qualified and unqualified areas, and have obvious signs; qualified spare materials shall also be stored separately according to different batches, and raw materials that affect each other's flavor shall not be stored in the same warehouse. 6.10. Raw materials with temperature, humidity and special requirements shall be stored according to the specified conditions; the storage place or warehouse of general raw materials shall have a flat ground, convenient ventilation, and rat and insect prevention facilities. 6.11. The storage period of raw materials shall be formulated, and the first-in-first-out principle shall be adopted. Unqualified or expired raw materials shall be marked and handled as soon as possible. 6.12 For mycelium obtained by artificial fermentation of fungi or microecological materials, the preservation conditions of strains should be strictly controlled. The strains should be screened and purified regularly, and identified when necessary to prevent contamination by foreign bacteria, strain degradation and mutation and toxin production. 7 Production process
7.1 Formulate production operation procedures
7.1.1 Factories should formulate production process procedures and job operation procedures in accordance with the requirements of this specification and in combination with the production process characteristics of their own products. The production process procedures must meet the process requirements of no loss, no destruction, no transformation and no generation of harmful intermediates in the process of health food processing. Its contents should include product formula, preparation of each component, main technical conditions of finished product processing and quality and hygiene monitoring points of key processes, such as temperature, pressure, time, pH value, quality indicators of intermediate products, etc. in the process of finished product processing. The job operation procedures should specify specific operation requirements for each major production process and clarify the job responsibilities of each workshop, process and individual. 7.1.2 The production technicians and management personnel of each production workshop shall record the raw material preparation, intermediate product output, product quality and hygiene indicators of each batch of products according to the control items and inspection requirements of each key process in the production process. 7.2 Collection and feeding of raw and auxiliary materials
7.2.1 The raw materials before production must be strictly inspected to check the product name, specification and quantity. Those that are mutated, infested with insects, mixed with foreign matter or have other abnormal sensory characteristics and do not meet the quality standards shall not be put into production. All raw materials with a specified storage period shall not be used after the expiration date. Liquid raw and auxiliary materials shall be filtered to remove foreign matter; solid raw and auxiliary materials that need to be crushed and sieved shall be crushed to the specified fineness. 7.2.2 The workshop shall collect raw and auxiliary materials according to production needs, calculate, weigh and feed according to the formula correctly. The calculation, weighing and feeding of the formula raw materials shall be reviewed by two people and recorded for reference.
7.2.3 The quality of production water must comply with the provisions of GB5749. For special process water, it shall be further purified according to the process requirements.
7.3 Batching and processing
7.3.1 Before batching the product, check whether the batching pot and container pipes are clean and meet the standards required by the process. The fermentation tanks, containers and pipes used in the fermentation process must be thoroughly cleaned and disinfected before they can be used in production. Records of equipment cleaning and disinfection should be kept for each shift.
GB174051998
7.3.2 The production operation should be connected reasonably, and the transmission should be fast and convenient to prevent cross contamination. The processes of raw material processing, intermediate product processing, cleaning, disinfection of packaging materials and containers, finished product packaging and inspection should be set separately. Different products shall not be produced at the same time in the same workshop: containers of different processes shall be clearly marked and shall not be mixed. 7.3.3 Production operators shall strictly follow the different requirements of general production areas and clean areas and take good personal hygiene. When changing work positions may cause product contamination, work clothes, shoes, and hats must be changed and disinfected again. Work clothes, hats, shoes, etc. used in clean areas must be strictly cleaned and disinfected, changed daily, and only allowed to be worn in the clean area, and not pushed out of the area. 7.3.4 Raw and auxiliary materials must enter the production area through the material channel. All materials entering the clean workshop must be removed from the outer packaging. If the outer packaging cannot be removed, it must be scrubbed clean or replaced with an indoor packaging barrel. 7.3.5 The raw and auxiliary materials must be mixed evenly during the preparation process. If the materials need to be hot-melted, hot-extracted or concentrated (evaporated), the heating temperature and time must be strictly controlled. If the technical parameters such as content and pH value of the intermediate product need to be adjusted, the content, pH value, relative density, preservatives, etc. must be re-measured and verified after adjustment.
7.3.6 All process operations should be carried out in a good state that meets the process requirements. If the production process of liquid products such as oral liquids and beverages requires filtration, attention should be paid to the selection of filter materials that do not shed fibers and meet hygiene requirements. Asbestos is prohibited as a filter material. For solid products such as capsules, tablets, and granules that need to be dried, the drying room (box) temperature and time should be strictly controlled to prevent the particles from melting and deteriorating: the crushing, tableting, screening or granulation equipment should be made of materials that meet the hygienic requirements, and should be cleaned and maintained regularly to avoid contamination by rust and metal pollutants. 7.3.7 Product tableting, sub-packaging of capsules, granules, and filling of liquid products should all be carried out in a clean room, and the temperature and humidity of the operating room should be controlled. Manual sub-packaging of capsules should be carried out in a plexiglass cover with the corresponding cleanliness level, and the operating table should not be lower than 0.? m. 7.3.8 The prepared materials must be placed in a clean and sealed container and enter the filling, tableting or sub-packaging of capsules in a timely manner. Those that need to be stored must not exceed the specified period.
7.4 Washing, sterilization and cleaning of packaging containers 7.4.1 Food containers, packaging materials, detergents and disinfectants that meet the hygienic standards and the provisions of the hygienic management methods should be used. 7.4.2 The raw materials such as empty capsules and sugar coatings used must meet the hygienic requirements, and the use of non-food coloring is prohibited. 7.4.3 For product packaging, various glass bottles (tubes), plastic bottles (tubes), bottle caps, bottle pads, bottle stoppers, aluminum-plastic packaging materials, etc., all inner packaging materials that are in direct contact with the product should be cleaned, dried and sterilized by appropriate methods, and should be placed in a clean room for cooling after sterilization. If the storage time exceeds the prescribed period, it should be washed and sterilized again.
7.5 Strict product sterilization
7.5.1 Effective sterilization or sterilization equipment and methods should be used for sterilization of various products. For products that need to be sterilized but cannot be sterilized by hot pressure, fine filtration, microwave, irradiation and other methods can be used according to different processes and food hygiene requirements to ensure the sterilization effect. When using irradiation sterilization methods, the provisions of the "Irradiation Food Hygiene Management Measures" should be strictly followed to strictly control the radiation absorption dose and time. 7.5.2 The uniformity and repeatability of the temperature in the sterilization or sterilization device should be regularly verified for reliability, and the temperature, pressure and other detection instruments should be regularly calibrated. Indicators such as temperature, pressure and time should be accurately recorded during the sterilization or sterilization operation. 7.6 Filling or loading of products
7.6.1 Each batch of products to be filled and loaded should be checked for quality to see if they meet the requirements, and the output rate should be calculated and compared with the actual output rate. If there is a significant difference, the cause must be found out. After a reasonable explanation is given and it is confirmed that there is no potential quality accident, it can be processed as a normal product with the approval of the quality management department.
7.6.2 The filling of liquid products, the granulation, tableting and loading of solid products should be carried out in the clean area according to the corresponding requirements. Except for capsules, the filling and loading of products must be carried out using automatic mechanical devices and manual operation is not allowed. 7.6.3 Before filling, check whether the filling equipment, needles, pipes, etc. are rinsed, disinfected or sterilized with fresh distilled water. 7.6.4 The operator must frequently check the quality of the semi-finished products after filling and sealing, and adjust the filling (sealing) machine at any time to ensure the filling and sealing quality. 7.6.5 For products that need to be sterilized, the time from filling to sterilization should be controlled within the time limit required by the process regulations. 7.6.6 Oral anying preparations and straight glass bottles and other bottled liquid preparations should be inspected by light after filling. After each batch of light inspection, the site must be cleared. The rejected products should be marked with the product name, specification, and batch number, placed in a clean container and handed over to a designated person for disposal. 7.7 Packaging
GB 17405--1998
7.7.1 The packaging materials and labels of health foods should be kept by a designated person. Each batch of product labels should be issued and used according to instructions, and the destroyed packaging materials should be recorded.
7.7.2 During the printing or labeling process of semi-finished products that have passed the light inspection and inspection, the quality of printing or labeling should be checked at any time. The printing should be clear: the label should be affixed correctly and firmly.
7.7.3 Items not related to food should not be placed in the finished product packaging. 7.7.4 The maximum pressure (weight) should be indicated on the outer packaging of the product. 7.8 Labeling
7.8.1 Product labeling must comply with the requirements of the "Health Food Labeling Regulations" and GB7718. 7.8.2 The printing of health food product instructions and labels should be consistent with the content approved by the Ministry of Health. 8 Finished Product Storage and Transportation
8.1 The general hygiene requirements for storage and transportation should comply with the requirements of GB14881. 8.2 The storage method and environment of finished products should be protected from light and rain, and the temperature and filtration should be controlled within an appropriate range, and avoid impact and vibration. 8.3 Products containing bioactive substances should be refrigerated and spread accordingly, and stored and transported in a cold chain manner. 8.4 Health foods stored at abnormal temperatures (such as some microecological health foods) should be transported according to the required intake according to the different characteristics of the products.
8.5 The warehouse should have a receiving and shipping inspection system. The principle of "production first, sales first" should be followed when the finished products leave the factory. 8.6 There should be inventory records for finished products entering the warehouse, and there should be shipping records for finished products leaving the warehouse, which should at least include batch number, shipping time, location, object, quantity, etc., so that problems can be found and recovered in time.
9 Quality Management
9.1 The factory must set up an independent quality management organization that is commensurate with its production capacity and is directly led by the person in charge of the factory. Each workshop shall have a full-time quality inspector, and each team shall have a part-time quality inspector to form a complete and effective quality monitoring system, which is responsible for quality supervision of the entire production process. 9.2 Formulation and Implementation of Quality Management System
9.2.1 The quality management organization must formulate a complete management system, and the quality management system should include the following contents a) Raw materials, intermediate products, finished products and unqualified h) Management system for raw materials identification and quality inspection, inspection of intermediate products, and technical regulations for inspection of finished products, such as quality specifications, inspection items, inspection standards, sampling and inspection methods, etc.: c) Management system for sample retention observation and laboratory management system; d) Production process operation verification system,
e) Clearing management system;
1) Various original records and batch production record management systems;) Archives management system.
9.2.2 The above management systems should be practical, easy to operate and check. 9.3 Inspection rooms and laboratories that are suitable for the types of products produced must be set up, and should have the rooms, instruments, equipment and instruments required for the inspection of raw materials, semi-finished products and finished products, and should be regularly inspected to keep them in good condition. 9.4 Quality management of raw materials
9.4.1 Quality inspection personnel must be appointed in accordance with the regulations of the state or relevant departments to identify and inspect the quality of raw materials batch by batch. Unqualified ones shall not be used.
9.4.2 The storage places of raw materials must be inspected and managed. Places where storage conditions do not meet the requirements shall not be used. 9.5 Quality management of the process
9.5.1 Identify the key control points of quality and hygiene in the processing process, at least monitor the following links, and keep records. 9.5.1.1 Name and weight (or volume) of the feed. 723
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9.5.1.2 Technical parameters such as temperature, pressure, time, pH, etc. in the process of extracting effective ingredients. 9.5.1.3 Intermediate products 9.5.1.4 Output rate and quality specifications of finished products. 9.5.1.5 Sanitary conditions of inner packaging materials in direct contact with food. 9.5.1.6 Technical parameters of sterilization methods for finished products. 9.5.2 Important production equipment and measuring instruments should be regularly inspected and maintained. Thermometers and pressure gauges used for sterilization equipment should be inspected and maintained at least once every six months, and maintenance records should be kept.
9.5.3 The ability to monitor the production environment should be possessed, and the temperature, humidity, air purification degree and other indicators of the key process environment should be monitored regularly.
9.5.4 The ability to monitor production water should be possessed, and it should be monitored regularly. 9.5.5 For abnormal conditions found during the quality management process, the causes should be quickly identified, recorded, and corrected. 9.6 Quality management of finished products
9.6.1 The finished products must be inspected for sensory, hygiene and quality indicators batch by batch, and those that fail to meet the standards shall not be shipped out of the factory. 9.6.2 The company shall have the ability to test the main efficacy factors or ingredients of the product, and test the efficacy factors or main efficacy ingredients of the product produced each time. Products that fail to meet the standards shall not be shipped out of the factory. 9.6.3 Each batch of products shall have samples, which shall be stored in a special sample storage (or area), classified by type and batch number, and clearly marked.
9.6.4 Product stability tests shall be conducted regularly. 9.6.5 The packaging materials, labels, and instructions of the product must be inspected, and products that fail to meet the standards shall not be used. 9.6.6 The storage conditions of the finished product warehouse shall be inspected and managed, and warehouses that do not meet the storage conditions shall not be used. 9.7 Other requirements for quality management
9.7.1 The quality opinions raised by users and adverse reactions during use shall be recorded in detail, and investigation and handling shall be done well, and records shall be kept for reference.
9.7.2 A complete quality management file must be established, with filing cabinets and file management personnel, and various records shall be classified and filed, and kept for reference for 2 to 3 years.
9.7.3 Comprehensive inspections should be conducted regularly on production and quality, and various operating procedures and job responsibility systems in production and management should be verified. Problems found during inspections or verifications should be adjusted, and the production quality of products should be reported to the health administration department regularly. 10 Hygiene management
The factory should carry out hygiene management work such as pest control, pest control, toxic and harmful substance treatment, animal husbandry, sewage and waste treatment, and by-product treatment in accordance with the requirements of GB14881.3 Each batch of products should have a sample, which should be stored in a special sample storage (or area), classified and stored by type and batch number, and clearly marked.
9.6.4 Product stability tests should be conducted regularly. 9.6.5 The packaging materials, labels, and instructions of the products must be inspected, and those that do not meet the requirements must not be used. 9.6.6 Check and manage the storage conditions of the finished product warehouse, and warehouses that do not meet the storage conditions must not be used. 9.7 Other requirements for quality management
9.7.1 The quality opinions raised by users and adverse reactions during use should be recorded in detail, and investigation and handling should be done well, and records should be kept for reference.
9.7.2 A complete quality management file must be established, with filing cabinets and file management personnel, and various records should be classified and filed, and kept for 2 to 3 years for reference.
9.7.3 A comprehensive inspection of production and quality should be conducted regularly, and various operating procedures and job responsibility systems in production and management should be verified. Adjust the problems found in the inspection or verification, and report the production quality of the products to the health administration department regularly. 10 Health Management
The factory should do a good job in the health management of pest control, pest control, toxic and harmful substance treatment, animal breeding, sewage and waste treatment, by-product treatment, etc. in accordance with the requirements of GB14881.3 Each batch of products should have a sample, which should be stored in a special sample storage (or area), classified and stored by type and batch number, and clearly marked. bZxz.net
9.6.4 Product stability tests should be conducted regularly. 9.6.5 The packaging materials, labels, and instructions of the products must be inspected, and those that do not meet the requirements must not be used. 9.6.6 Check and manage the storage conditions of the finished product warehouse, and warehouses that do not meet the storage conditions must not be used. 9.7 Other requirements for quality management
9.7.1 The quality opinions raised by users and adverse reactions during use should be recorded in detail, and investigation and handling should be done well, and records should be kept for reference.
9.7.2 A complete quality management file must be established, with filing cabinets and file management personnel, and various records should be classified and filed, and kept for 2 to 3 years for reference.
9.7.3 A comprehensive inspection of production and quality should be conducted regularly, and various operating procedures and job responsibility systems in production and management should be verified. Adjust the problems found in the inspection or verification, and report the production quality of the products to the health administration department regularly. 10 Health Management
The factory should do a good job in the health management of pest control, pest control, toxic and harmful substance treatment, animal breeding, sewage and waste treatment, by-product treatment, etc. in accordance with the requirements of GB14881.
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