"Good Manufacturing Practice for Health Food"
Nina Environmental Protection Technology Co., Ltd. Shanghai 2008-10-27 23:41:37
In the writing process of this standard, part of the content regarding clean room factories in the "China Good Manufacturing Practice for Pharmaceutical Products" (revised edition of 1992) was adopted. In terms of writing format and content, reference was made to the World Health Organization (WHO)'s "Good Manufacturing Practice for Pharmaceutical Products". Regarding general building design and hygiene requirements, GB 14881-1994 "General Hygiene Standard for Food Enterprises" was referred to.
Since this standard falls within the scope of food production, the requirements for personnel, construction facilities, and document retention are lower than those for pharmaceutical production quality management standards but higher than those for the "General Hygiene Standard for Food Factories."
This standard fully references the principles of Hazard Analysis Critical Control Point (HACCP), proposing specific requirements at some key stages.
This standard was proposed by the Ministry of Health of the People's Republic of China.
This standard was drafted by the Food Hygiene Supervision and Inspection Institute of the Ministry of Health; co-drafted by the Fujian Provincial Food Hygiene Supervision and Inspection Institute, Guangdong Provincial Food Hygiene Supervision and Inspection Institute, Liaoning Provincial Food Hygiene Supervision and Inspection Institute, Shenyang Municipal Health and Epidemic Prevention Station, Tianjin Municipal Health and Disease Prevention Center, and Fujian Fulong Biological Products Co., Ltd.
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, Sheng Wei.
This standard is commissioned by the Ministry of Health and interpreted by the Food Hygiene Supervision and Inspection Institute of the Ministry of Health.
1 Scope
This standard specifies the basic technical requirements for personnel, design and facilities, raw materials, production process, finished product storage and transportation, as well as quality and hygiene management for enterprises producing health foods with specific functions.
This standard applies to all health food production enterprises.
2 Referenced Standards
The following standards contain provisions that become provisions of this standard through citation. At the time of publication of this standard, the editions shown were valid. All standards will be revised, and parties using this standard should explore the possibility of using the latest editions of the following standards.
GB J73-84 Design Code for Clean Rooms
GB 5749-85 Sanitary Standard for Drinking Water
GB 7718-94 General Standard for Food Labeling
GB 14881-94 General Hygiene Standard for Food Enterprises
3 Definitions
This standard adopts the following definitions.
3.1 Raw Materials
All inputs used in the production of health foods, including processing aids and food additives.
3.2 Intermediate Product
Substances or mixtures requiring further processing.
3.3 Product
Finished products ready for sale after being packaged in a fixed form.
3.4 Batch Number
A set of numbers or letters plus numbers used to identify a "batch." It can be used to trace and review the production history of the batch of health food.
4 Personnel
4.1 Health food production enterprises must have technicians with relevant professional knowledge in medicine (or biology, food science), etc., and managers with production and organizational capabilities that match 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 enterprise's technical director must have a college degree or equivalent education and experience in health food production and quality and hygiene management.
4.3 The heads of the health food production and quality management departments must be full-time personnel, with a college degree or equivalent education matching their profession, capable of organizing production or conducting quality management according to the requirements of this standard, and able to make correct judgments and handle actual problems arising in health food production and quality management.
4.4 Health food production enterprises must have full-time quality inspection personnel. Quality inspectors must have a secondary vocational school education or above; procurement personnel should master the knowledge and skills to identify whether raw materials meet quality and hygiene requirements.
4.5 Employees must undergo health regulations education and corresponding technical training before taking up their posts. Enterprises should establish training and assessment files. Enterprise directors and heads of production and quality management departments should also receive professional training on health foods from provincial-level or above health supervision departments and obtain qualified certificates.
4.6 Employees must undergo health checks and obtain health certificates before starting work, followed by an annual health check.
4.7 Employees must maintain personal hygiene according to the requirements of GB 14881 "General Hygiene Standard for Food Enterprises."
5 Design and Facilities
5.1 Design
The overall design of health food factories, general design of buildings and facilities, construction, and sanitary facilities should comply with the requirements of GB 14881 "General Hygiene Standard for Food Enterprises."
5.2 Buildings and Building Facilities
5.2.1 Buildings should be reasonably laid out according to the production process flow and required cleanliness levels. Production operations in the same building and adjacent buildings should not interfere with each other.
5.2.2 Cleanliness levels must be divided according to the production process and hygiene and quality requirements. In principle, they are divided into general production areas and 100,000-grade areas.
100,000-grade clean areas should be equipped with appropriate air conditioning facilities with filtration devices.
See Table 1 for building cleanliness levels and air changes per hour.
Table 1:
Clean Level Dust/m² Live Microbes/m² Air Changes/hour
≥0.5μm ≥5μm
10,000-grade ≤350,000 ≤2,000 ≤100 ≥20 times
100,000-grade ≤3,500,000 ≤20,000 ≤500 ≥15 times
5.2.3 The design and installation of clean rooms should comply with GB J73 requirements.
5.2.4 The purification level must meet the needs of air purification for health food production. Tablets, capsules, pills, and oral liquids that cannot be sterilized in their final containers should adopt 100,000-grade clean rooms.
5.2.5 Buildings, equipment layout, and production processes should be reasonably connected. The building structure should be complete and meet the needs of production processes and quality and hygiene requirements. There should be sufficient space and area to accommodate equipment and materials. Storage rooms for intermediate products and packaging goods should be adapted to production requirements.
5.2.6 The temperature and relative humidity in clean rooms should be adapted to production process requirements.
5.2.7 Sewage systems, handwashing stations, and other sanitary cleaning facilities installed in clean rooms should not contaminate health food production.
5.2.8 Between different cleanliness-level buildings or between buildings and passages, there should be buffer facilities. Personnel and material channels should be set up separately according to the corresponding cleanliness levels.
5.2.9 Preliminary treatment of raw materials (such as extraction, concentration, etc.) should be carried out in places suitable for their production scale and process requirements, equipped with necessary ventilation, dust removal, and cooling facilities. Preliminary treatment of raw materials should not share the same production building with finished product production.
5.2.10 Health food production should have a preparation room, whose cleanliness level should correspond to the production process requirements.
5.2.11 Air purification facilities and equipment in clean rooms should be regularly inspected, and appropriate measures should be taken during maintenance to avoid contaminating health food production.
5.2.12 Production of fermented products should have dedicated fermentation workshops and corresponding specialized equipment for fermentation and spray drying.
5.2.13 Tools and equipment that come into direct contact with raw materials and intermediate products should be made of materials that meet product quality and hygiene requirements.
6 Raw Materials
6.1 Procedures for acceptance, storage, use, and testing of raw materials used in health food production should be established and managed by designated personnel.
6.2 Raw materials must meet food hygiene requirements. The type, source, specifications, and quality of raw materials should align with approved formulas and corporate standards.
6.3 Valid inspection reports should be obtained for purchased raw materials according to relevant regulations. For new food resources, approval certificates from the Ministry of Health (copies) should be obtained.
6.4 For microbial strains used in artificial fermentation, strain identification reports, stability reports, and proof that the strain does not contain antibiotic resistance factors should be obtained.
6.5 For algae, animal tissues, or organs as raw materials, species identification reports should be obtained. For single active substances extracted from animals or plants or synthetic materials, physicochemical properties and content detection reports should be provided.
6.6 For raw materials containing stimulants or hormones, content detection reports should be obtained. For irradiated materials, relevant data on irradiation doses should be obtained.
6.7 Transportation tools for raw materials should meet hygiene requirements. Corresponding insulation, refrigeration, preservation, rainproofing, and dustproofing facilities should be equipped based on the characteristics of the raw materials to ensure quality and hygiene needs. During transportation, raw materials should not be mixed with toxic or harmful items in the same vehicle or container.
6.8 After purchase, preliminary checks should be conducted on the origin, specifications, and packaging conditions of raw materials. According to the acceptance system, entry records should be filled out, and samples should be sent to the quality inspection department for testing upon entry.
6.9 Various raw materials should be stored off the ground in separate zones for inspection, qualification, and disqualification, with clear markings. Qualified materials should be stored separately by batch. Flavors that may affect each other should not be stored in the same warehouse.
6.10 Raw materials with temperature, humidity, or special requirements should be stored under specified conditions. General raw material storage areas or warehouses should have flat floors, facilitate ventilation, and have rodent and pest control facilities.
6.11 A storage period for raw materials should be established, adopting the first-in-first-out principle. Unqualified or expired raw materials should be marked and handled promptly.
6.12 For microbial strains used in artificial fermentation or microecological raw materials, strict control over strain preservation conditions should be exercised. Strains should be periodically screened, purified, and identified if necessary to prevent contamination by foreign bacteria, strain degeneration, and toxin production.
7 Production Process
7.1 Establishing Production Operating Procedures
7.1.1 Factories should develop production and job operating procedures based on this standard and their own product production process features.
Production operating procedures should meet the process requirements of health food production, ensuring no loss, damage, transformation, or generation of harmful intermediates during the efficacy component processing. Content should include product formula, preparation of each component, major technical conditions and critical quality and hygiene monitoring points in the finished product processing process, such as temperature, pressure, time, pH value, quality indicators of intermediate products, etc.
Job operating procedures should specify detailed operational requirements for each main production process and clarify the responsibilities of workshops, processes, and individuals.
7.1.2 Technical and management personnel in each workshop should record the situation of each batch of products from raw material formulation, intermediate product yield, product quality, and hygiene indicators according to the control items and inspection requirements in the production process.
7.2 Receipt and Use of Raw and Auxiliary Materials
7.2.1 Before production, raw materials must be strictly inspected, verifying name, specification, and quantity. Moldy, insect-infested, mixed with foreign matter or other abnormal sensory characteristics, or not meeting quality standard requirements, shall not be used in production. Raw materials with a specified storage period must not be used after expiration. Liquid raw and auxiliary materials should be filtered to remove foreign objects; solid raw and auxiliary materials that need to be crushed and sieved should be processed to the specified fineness.
7.2.2 Workshops should collect raw and auxiliary materials according to production needs, correctly calculate, weigh, and add them according to the formula. Calculation, weighing, and addition of formula raw materials must be double-checked by two people and recorded for future reference.
7.2.3 The quality of water used in production must comply with GB 5749. Special process water should be further purified according to process requirements.
7.3 Mixing and Processing
7.3.1 Before mixing products, check whether the mixing pot and container pipelines are cleaned thoroughly and meet the process standard. Fermentation tanks, containers, and pipelines used in fermentation production must be thoroughly cleaned and disinfected before use. Cleaning and disinfection records should be kept for each shift.
7.3.2 Production operations should be reasonably connected, quick, and convenient, preventing cross-contamination. Raw material processing, intermediate product processing, cleaning and disinfecting of packaging materials and containers, finished product packaging, and inspection should be set up separately. Different products should not be produced simultaneously in the same workshop; different process containers should have obvious marks and not be mixed.
7.3.3 Production operators should strictly follow the different requirements of general production areas and clean areas to maintain personal hygiene. If changing jobs could lead to product contamination, work clothes, shoes, and hats must be changed, and re-disinfection must be performed. Clean area work clothes, hats, and shoes must be strictly washed and disinfected daily, only allowed to be worn in clean areas, and not taken outside.
7.3.4 Raw and auxiliary materials entering the production area must pass through the material channel. Materials entering clean rooms and workshops must remove outer packaging. If the outer packaging cannot be removed, it must be wiped clean or replaced with indoor packaging buckets.
7.3.5 Raw and auxiliary materials must be mixed evenly during the preparation process. If materials need to be thermally melted, thermally retrieved, or concentrated (evaporated), heating temperature and time must be strictly controlled. If intermediate products need adjustment of content, pH value, etc., these parameters must be retested and verified after adjustment.
7.3.6 Each process operation should be carried out under good conditions that meet process requirements. Oral liquid, beverage, and other liquid product production processes that require filtration should use filter materials without fiber shedding and meeting hygiene requirements; asbestos as a filter material is prohibited. Solid products like capsules, tablets, and granules that need drying should strictly control oven (box) temperature and time to prevent particle melting and deterioration. Crushing, tablet pressing, sieving, or whole grain equipment should be made of materials meeting hygiene requirements and regularly cleaned and maintained to avoid rust and metal contamination.
7.3.7 Tablet pressing, capsule filling, granule production, and liquid product filling should be carried out in clean rooms. The temperature and humidity of the operation room should be controlled. Manual capsule filling should be conducted in an organic glass hood with the corresponding cleanliness level, with the operating table not lower than 0.7 meters.
7.3.8 Prepared materials should be placed in clean sealed containers and promptly transferred to filling, tablet pressing, or capsule filling processes. If storage is needed, it should not exceed the specified time limit.
7.4 Washing, Sterilization, and Maintenance of Packaging Containers
7.4.1 Food containers, packaging materials, detergents, and disinfectants that meet hygiene standards and management methods should be used.
7.4.2 Empty capsules and sugar coatings used must meet hygiene requirements, and non-edible pigments are prohibited.
7.4.3 Various glass bottles (tubes), plastic bottles (tubes), bottle caps, bottle pads, bottle stoppers, aluminum-plastic packaging materials, etc., which are inner packaging materials directly contacting products, should be appropriately cleaned, dried, and sterilized. After sterilization, they should be cooled in a clean room and stored for use. If the storage time exceeds the specified period, they should be rewashed and resterilized.
7.5 Product Sterilization
7.5.1 Sterilization of various products should select effective sterilization equipment and methods. For products requiring sterilization but unable to undergo heat-pressure sterilization, depending on different processes and food hygiene requirements, methods such as fine filtration, microwave, or irradiation can be used to ensure sterilization effects. When using irradiation sterilization, the "Hygiene Management Method for Irradiated Foods" should be strictly followed, controlling irradiation absorbed dose and time.
7.5.2 The uniformity and repeatability of temperature inside sterilization or sterilizing equipment should be regularly validated, and temperature and pressure detection instruments should be regularly calibrated. During sterilization or sterilizing operations, temperature, pressure, and time indicators should be accurately recorded.
7.6 Product Filling or Packing
7.6.1 Each batch of products awaiting filling or packing should check whether the quality meets requirements, calculate output rate, and compare with actual output rate. If there is a significant difference, the cause must be identified. After obtaining a reasonable explanation and confirming no potential quality accidents, with the approval of the quality management department, it can be treated as a normal product.
7.6.2 Liquid product filling, solid product granulation, tablet pressing, and packing should be carried out in clean areas according to corresponding requirements. Except for capsules, automatic mechanical devices should be used for filling and packing, manual operations are prohibited.
7.6.3 Before filling, check whether filling equipment, needles, pipes, etc., have been rinsed with fresh distilled water, disinfected, or sterilized.
7.6.4 Operators must frequently check the quality of semi-finished products after filling and sealing, adjust the filling (sealing) machine at any time to ensure filling and sealing quality.
7.6.5 For products requiring sterilization, the time from filling to sterilization should be controlled within the time limit specified in the process procedure.
7.6.6 After filling and sealing oral ampoule formulations and straight glass bottle liquid formulations, lamp inspections should be conducted. After each batch of lamp inspections, clean-up work must be done, and rejected products should be clearly labeled with name, specification, batch number, placed in clean containers, and handed over to designated personnel for handling.
7.7 Packaging
7.7.1 Packaging materials and labels for health foods should be managed by designated personnel. Each batch of product labels should be issued according to instructions, and destroyed packaging materials should have records.
7.7.2 Semi-finished products passing lamp inspections and inspections should be randomly checked during printing or labeling. Printing should be clear, and labeling should be accurate and secure.
7.7.3 No items unrelated to food should be included in finished product packaging.
7.7.4 External packaging of products should indicate maximum allowable pressure (weight).
7.8 Identification
7.8.1 Product identification must comply with the "Regulations for Identifying Health Foods" and GB 7718 requirements.
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 General hygiene requirements for storage and transportation should comply with GB 14881 requirements.
8.2 Storage methods and environments for finished products should avoid light, rain, and maintain temperature and humidity within appropriate ranges, avoiding impact and vibration.
8.3 Products containing bioactive substances should adopt corresponding cold storage measures and be stored and transported through a cold chain.
8.4 Health foods requiring non-ambient temperature storage (e.g., some microecological health foods) should be stored and transported according to product characteristics and required temperatures.
8.5 Warehouses should have receiving and shipping inspection systems. Finished product shipments should follow the "first produced, first sold" principle.
8.6 Finished product warehousing should have inventory records; outgoing finished products should have shipment records, including at least batch number, shipment time, location, recipient, and quantity, facilitating timely recovery if issues arise.
9 Quality Management
9.1 Factories must set up independent quality management institutions commensurate with production capacity, directly led by factory leaders. Each workshop should have full-time quality supervisors, and each team should have part-time quality inspectors, forming a complete and effective quality monitoring system responsible for supervising the entire production process.
9.2 Formulation and Implementation of Quality Management Systems
9.2.1 Quality management institutions must formulate comprehensive management systems. Quality management systems should include the following contents:
a) Management systems for raw and auxiliary materials, intermediate products, finished products, and non-conforming products;
b) Technical operating procedures for raw material identification and quality inspection, intermediate product inspection, finished product inspection, including quality specifications, inspection items, inspection standards, sampling and inspection methods, etc.;
c) Sample retention observation system and laboratory management system;
d) Process operation verification system;
e) Clean-up management system;
f) Management system for various original records and batch production records;
g) Archive management system.
9.2.2 The above management systems should be practical, easy to operate and inspect.
9.3 Testing Room and Laboratory Setup
There must be testing rooms and laboratories commensurate with the types of products produced, equipped with rooms, instruments, equipment, and tools needed for testing raw materials, semi-finished products, and finished products, and these should be regularly calibrated to ensure they remain in good condition.
9.4 Raw Material Quality Management
9.4.1 Quality inspection personnel must be assigned according to national or relevant department regulations, and each batch of raw materials must be identified and quality-checked, with non-conforming ones not being used.
9.4.2 The storage area for raw materials should be inspected and managed, and areas with unsuitable storage conditions should not be used.
9.5 Quality Management in the Processing Process
9.5.1 Identify the key control points for quality and hygiene in the processing process, at least monitoring the following links and keeping records:
9.5.1.1 Names and weights (or volumes) of ingredients added.
9.5.1.2 Technical parameters such as temperature, pressure, time, and pH in the effective component extraction process.
9.5.1.3 Yield and quality specifications of intermediate products.
9.5.1.4 Yield and quality specifications of finished products.
9.5.1.5 Hygiene status of inner packaging materials directly contacting food.
9.5.1.6 Technical parameters of the sterilization method for finished products.
9.5.2 Important production equipment and measuring instruments should be regularly maintained, with thermometers and pressure gauges used in sterilization equipment being inspected at least every six months and repair records kept.
9.5.3 There should be the ability to monitor the production environment, and regular monitoring of key process environmental indicators such as temperature, humidity, and air purification should be conducted.
9.5.4 There should be the ability to monitor production water, and regular monitoring should be conducted.
9.5.5 Abnormal situations discovered during the quality management process should be quickly investigated, recorded, and corrected.
9.6 Finished Product Quality Management
9.6.1 Each batch of finished products must undergo sensory, hygiene, and quality indicator inspections, with non-conforming ones not being shipped.
9.6.2 There should be the ability to detect the main efficacy factors or efficacy components of the product, and each batch of products produced from raw materials should be tested for efficacy factors or main efficacy components, with non-conforming ones not being shipped.
9.6.3 Each batch of products should have retained samples, which should be stored in a designated sample retention warehouse (or area), classified and stored by type and batch number, with clear markings.
9.6.4 Regular product stability tests should be conducted.
9.6.