In the process of compiling this standard, the contents of "good manufacturing practice, China" (revised version 1992) about clean workshop were partially adopted. In the format and content, it refers to the good manufacturing practice of the World Health Organization (who). General architectural design and hygiene requirements refer to GB14881-1994 General Hygienic Standard for Food Enterprises.
As this standard belongs to the category of food production, the requirements for employees, building facilities and document preservation are lower than good production practices, but higher than the general hygiene standards of food factories.
The formulation of this standard fully refers to the principle of Hazard Analysis Critical Control Point (haccp), and puts forward specific requirements in some key links.
This standard is 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; This standard was drafted by Fujian Food Hygiene Supervision and Inspection Institute, Guangdong Food Hygiene Supervision and Inspection Institute, Liaoning Food Hygiene Supervision and Inspection Institute, Shenyang Health and Epidemic Prevention Station, Tianjin Health Disease Prevention Center and Fujian Long Fu Biological Products Co., Ltd. ..
Main drafters of this standard: Bao Dayue, Li Tairan, Lin Shengqing, Zhang Yonghui, Shi Gensheng, Xiao Dongsheng, Liu Changhui, Liu Hongde, Zheng Pengran and Sheng Wei.
Entrusted by the Ministry of Health, this standard is interpreted by the Food Hygiene Supervision and Inspection Institute of the Ministry of Health.
1. range
This standard stipulates the basic technical requirements for personnel, design and facilities, raw materials, production technology, storage and transportation of finished products, quality and hygiene management of food enterprises with specific health care functions.
This standard is applicable to all health food production enterprises.
2. Reference standards
The clauses contained in the following standards constitute the clauses of this standard by reference in this standard. At the time of publication of this standard, all versions shown are valid. All standards will be revised, and all parties using this standard should explore the possibility of using the latest version of the following standards.
Gb j73-84 Code for Design of Clean Workshop
Gb 5749-85 Hygienic standard for drinking water
Gb 77 18-94 General Standard for Food Labeling
Gb 1488 1-94 general hygienic standard for food enterprises.
3. Definition
This standard adopts the following definitions.
3. 1 raw materials
All inputs used in the production of health food, including processing AIDS and food additives.
3.2 Intermediate products
A substance or mixture that requires further processing.
3.3 products
After shaping and packaging, the finished product to be sold is formed.
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 this batch of health food.
4. Personnel department
4. 1 Health food production enterprises must have technicians with medical (or biological, food science) and other related professional knowledge and management personnel with production organization ability that are suitable for the health food produced. The proportion of full-time technical personnel shall not be less than 5% of the total number of employees.
4.2 The person in charge of technology in an enterprise must have a college degree or above, and have experience in health food production, quality and hygiene management.
4.3 The person in charge of the production and quality management department of health food must be a full-time person, who should have a college degree or above or a corresponding degree suitable for his major, be able to organize production or conduct quality management in accordance with the requirements of this specification, and be able to make correct judgments and treatments on practical problems arising in the production and quality management of health food.
4.4 Health food production enterprises must have full-time quality inspectors. Quality inspection personnel must have technical secondary school education or above; Purchasing personnel should master the knowledge and skills to identify whether raw materials meet the quality and hygiene requirements.
4.5 Employees must receive health laws and regulations education and corresponding technical training before taking up their posts. Enterprises should establish training assessment files, and the person in charge of the enterprise and the person in charge of the production and quality management departments should also accept the professional training of health food from the health supervision departments at or above the provincial level and obtain certificates.
4.6 Employees must have a health check-up before they can take up their posts, and then they must have a health check-up once a year.
4.7 Employees must perform personal hygiene according to gb 1488 1 General Hygiene Standard for Food Enterprises.
5. Design and facilities
5. 1 design
The overall design of health food factory, workshop and facilities, buildings and sanitary facilities should meet the requirements of gb 1488 1 General Hygienic Standard for Food Enterprises.
5.2 Factory and factory facilities
5.2. 1 Workshops shall be arranged reasonably according to the production process and required cleanliness level, and the production operations of the same workshop and adjacent workshops shall not interfere with each other.
5.2.2 The cleanliness grade must be divided according to the production process, hygiene and quality requirements, and in principle it can be divided into general production area and 654.38+10,000-level area.
654.38+100000 clean area should be equipped with corresponding purification air conditioning facilities with filtering devices.
See table 1 for the cleanliness and air exchange times of the workshop.
Number of clean dust /m2 Air exchange times of living microorganisms m2 /h
≥0.5μm≥5μm
Grade 0000 ≤350000≤2000≤ 100≥20 times.
00000 ≤ 3500000 ≤ 20000 ≤ 500 ≥15 times.
5.2.3 The design and installation of clean workshop shall meet the requirements of gb j73.
5.2.4 The purification grade must meet the needs of air purification in the production and processing of health food. The production of tablets, capsules, pills and oral liquid that cannot be sterilized in the final container should adopt a clean workshop of100000 level.
5.2.5 Workshop, equipment layout and process flow should be reasonably connected, and the building structure should be perfect to meet the requirements of production technology, 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 shall meet the production requirements.
5.2.6 The temperature and relative humidity of the clean workshop shall meet the requirements of the production process.
5.2.7 Sanitary cleaning facilities such as sewers and hand washing installed in the clean workshop shall not pollute the production of health food.
5.2.8 There should be buffer facilities between workshops with different cleanliness levels and between workshops and passages. Personnel and material passages suitable for cleanliness level shall be set up respectively.
5.2.9 Pretreatment of raw materials (such as extraction and concentration) should be carried out in a place 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 workshop as the production of finished products.
5.2. 10 Health food production should have a preparation room, and the cleanliness level of the preparation room should meet the production process requirements.
5.2. 1 1 The air purification facilities and equipment in the clean workshop should be overhauled regularly, and appropriate measures should be taken during overhaul to avoid polluting the production of health food.
5.2. The production of12 fermented products should have a special fermentation workshop and special equipment corresponding to fermentation and spraying.
5.2. 13 All production tools and equipment that come into direct contact with raw materials and intermediate products shall be made of materials that meet the product quality and hygiene requirements.
6. Raw materials
6. 1 The system of acceptance, storage, use and inspection shall be formulated for the procurement and use of raw materials required for the production of health food, and the special person shall be responsible for it.
6.2 raw materials must meet the requirements of food hygiene. The varieties, sources, specifications and quality of raw materials shall conform to the approved formula and product enterprise standards.
6.3 Purchasing raw materials must obtain effective inspection reports according to relevant regulations; Raw materials belonging to new food resources need to obtain the approval certificate (copy) from the Ministry of Health.
6.4 The mycelium or the mixture of mycelium and fermentation products made by artificial fermentation of fungi and microecological raw materials must obtain the strain identification report, stability report and proof that the strain does not contain drug resistance factors.
6.5 If algae, animals and animal tissues and organs are used as raw materials, a variety identification report must be obtained. If a single effective substance or biological or chemical compound extracted from animals and plants is used as raw material, a test report on the physical and chemical properties and content of the substance shall be obtained.
6.6 Raw materials containing stimulants or hormones shall obtain their content test reports; Raw materials exposed to radioactive radiation should obtain information about radiation dose.
6.7 The means of transport for raw materials shall meet the hygiene requirements. According to the characteristics of raw materials, it should be equipped with corresponding facilities such as heat preservation, cold storage, preservation, rain and dust prevention to ensure the quality and hygiene needs. Toxic and harmful substances shall not be mixed in the same carriage or container during transportation.
6.8 After purchasing raw materials, make a preliminary inspection on the source, specifications and packaging, fill in the warehousing account and card according to the provisions of the acceptance system, and apply to the quality inspection department for sampling inspection after warehousing.
6.9 All kinds of raw materials should be stored off the ground according to the areas to be inspected, qualified areas and unqualified areas, and clearly marked; Qualified spare parts should also be stored separately in batches, and raw materials that affect each other's flavor should not be placed in the same warehouse.
6. 10 Raw materials with special requirements on temperature and humidity shall be stored according to the specified conditions; The storage place or warehouse of general raw materials should be flat on the ground, which is convenient for ventilation and ventilation, and equipped with rat and insect prevention facilities.
6. 1 1 Determine the storage period of raw materials and adopt the principle of first in first out. Unqualified or expired raw materials should be marked and treated as soon as possible.
6. 12 Mycelium produced by artificial fermentation or microecology of fungi should strictly control the preservation conditions, regularly screen and purify the strains, and identify them when necessary to prevent contamination by miscellaneous bacteria, strain degradation and variation.
7. Production process
7. 1 Formulate production operation procedures
7. 1. 1 The factory shall formulate production process regulations and post operation regulations according to the requirements of this specification and the production process characteristics of its own products.
The production process specification should meet the process requirements of no loss, no damage, no transformation and no harmful intermediates in the processing of health food, and its contents should include the product formula, the preparation of each component, the main technical conditions in the processing of finished products, and the quality and hygiene monitoring points of key processes such as temperature, pressure, time, ph value and quality index of intermediate products in the processing of finished products.
The post operation procedures shall specify the specific operation requirements of each major production process, and define the post responsibilities of each workshop, process and individual.
7. 1.2 The production technology and management personnel of each production workshop should record the raw material preparation, intermediate product output, product quality and hygiene index of each batch of products according to the control items and inspection requirements of each key process in the production process.
7.2 Receiving and feeding of raw and auxiliary materials
7.2. 1 The raw materials before production must be strictly inspected to check the name, specification and quantity. Moldy, insect-infested, mixed with foreign matter or with other abnormal sensory properties, which do not meet the requirements of quality standards, shall not be put into production. Raw materials with specified storage period shall not be used after expiration. The liquid of raw and auxiliary materials should be filtered to remove impurities; If solid raw materials need to be crushed and sieved, they should be crushed to the specified fineness.
7.2.2 The workshop receives raw materials according to the production needs, and correctly calculates, weighs and feeds according to the formula. The calculation, weighing and feeding of formula raw materials shall be checked by two people and recorded for future reference.
7.2.3 The water quality of production water must comply with the provisions of gb 5749, and the process water with special provisions should be further purified according to the process requirements.
7.3 batching and processing
7.3. 1 Before product batching, it is necessary to check whether the batching pot and container pipes are clean and meet the standards required by the process. The fermenters, containers and pipes used in the fermentation process must be thoroughly cleaned and disinfected before they can be used in production. Each shift should make a good record of instrument cleaning and disinfection.
7.3.2 Production operations should be connected reasonably, quickly and conveniently to prevent cross-contamination. Raw material treatment, intermediate product processing, cleaning and disinfection of packaging materials and containers, finished product packaging and inspection should be set up separately. The same workshop shall not produce different products at the same time; Containers with different processes shall be clearly marked and shall not be mixed.
7.3.3 Production operators should improve personal hygiene in strict accordance with the different requirements of general production areas and clean areas. When changing jobs may lead to product pollution, work clothes, shoes and hats must be replaced and disinfected again. Work clothes, hats, shoes, etc. Those used in clean areas must be strictly cleaned and disinfected and replaced daily. They are only allowed to be worn in clean areas and are not allowed to be taken 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 and workshop must be removed from the outer packaging. If the outer packaging can't be removed, it should be scrubbed clean or the indoor packaging barrel should be replaced.
7.3.5 Raw materials and auxiliary materials must be evenly mixed in the preparation process, and the heating temperature and time must be strictly controlled if hot melting, heat extraction or concentration (evaporation) are needed. If the technical parameters such as the content and ph value of intermediate products need to be adjusted, the content, ph value, relative density and preservative should be determined again after adjustment, and the re-inspection should be carried out.
7.3.6 All technological operations shall be carried out in a good state meeting the technological requirements. If liquid products such as oral liquid and beverage need to be filtered in the production process, attention should be paid to selecting filter materials that are free from fiber shedding and meet hygiene requirements, and asbestos is prohibited from being used as filter materials. If solid products such as capsules, tablets and granules need to be dried, the temperature and time of the drying room (box) should be strictly controlled to prevent the granules from melting and deteriorating; Equipment used for saccharification, tabletting, screening or grading should be made of materials that meet the hygiene requirements, and should be cleaned and maintained regularly to avoid the pollution of rust and metal pollutants.
7.3.7 Product tabletting, sub-packaging capsules, granules and liquid products should be filled in a clean room, and the temperature and humidity in the operation room should be controlled. Manual subpackaging of capsules should be carried out in plexiglass cover with corresponding cleanliness grade, and the operating table should not be less than 0.7m.
7.3.8 The prepared materials shall be placed in clean and sealed containers, and shall enter the processes of filling, tabletting or sub-packaging capsules in time, and the materials shall not be stored for more than the specified period.
7.4 Does the packaging allow south blowing printing? Child =? /P & gt；
7.4. 1 Food containers, packaging materials, detergents and disinfectants that meet hygiene standards and hygiene management regulations shall be used.
7.4.2 Raw materials such as empty capsules and sugar coating used must meet the hygiene requirements, and non-edible pigments are prohibited.
7.4.3 Various glass bottles (tubes), plastic bottles (tubes), bottle caps, bottle cushions, bottle stoppers and aluminum-plastic packaging materials used for product packaging should be cleaned, dried and sterilized by appropriate methods, and then placed in a clean room for cooling. If the storage time exceeds the prescribed time limit, it should be cleaned and disinfected again.
7.5 product sterilization
7.5. 1 Effective sterilization or sterilization equipment and methods should be selected for sterilization of various products. For products that need to be sterilized but cannot be autoclaved, methods such as fine filtration, microwave and irradiation can be adopted according to different process and food hygiene requirements to ensure the sterilization effect. When using irradiation sterilization method, the absorbed dose and time of irradiation should be strictly controlled in accordance with the provisions of the Measures for the Hygienic Management of Irradiated Food.
7.5.2 Regularly verify the uniformity and repeatability of the temperature in the sterilization or sterilization device, and regularly check the testing instruments such as temperature and pressure. Temperature, pressure and time should be accurately recorded during sterilization or sterilization operation.
7.6 product filling or filling
7.6. 1 For each batch of products to be filled or filled, check whether the quality meets the requirements, calculate the output rate, and check with the actual output rate. If there are obvious differences, the reasons must be found out. After making a reasonable explanation and confirming that there are no hidden dangers of quality accidents, they can be treated as normal products with the approval of the quality management department.
7.6.2 Filling of liquid products, granulating, tabletting and filling of solid products shall be carried out in clean areas according to corresponding requirements. Except capsules, the filling and filling of products must use automatic mechanical devices, and manual operation is not allowed.
7.6.3 Before filling, check whether the filling equipment, needles and pipes are cleaned, disinfected or sterilized with fresh distilled water.
7.6.4 Operators must always check the quality of semi-finished products after filling and sealing, and adjust the filling (sealing) machine at any time to ensure the filling quality.
7.6.5 The time from filling to sterilization of products to be sterilized shall be controlled within the time limit required by the process regulations.
7.6.6 Oral ampoules, straight glass bottles and other bottled liquid preparations shall be inspected by lamp after filling and sealing. At the end of each batch of light inspection, it is necessary to do a good job of clearing the field. Rejected products should be marked with name, specification and batch number, and put in clean containers, which will be handled by special personnel.
7.7 packaging
7.7. 1 The packaging materials and labels of health food shall be kept by special personnel, and the labels of each batch of products shall be distributed and collected according to the instructions, and the destroyed packaging materials shall be recorded.
7.7.2 In the process of printing or labeling semi-finished products that have passed the lamp inspection and inspection, the quality of printing or labeling shall be checked at any time. Print clearly; Sticking labels should be straight and firm.
7.7.3 Items unrelated to food shall not be placed in the finished product package.
7.7.4 The pressure (weight) shall be indicated on the outer package of the product.
7.8 Identification
7.8. 1 Product identification must meet the requirements of Regulations on the Management of Health Food Labeling and gb 77 18.
7.8.2 The printed instructions and labels of health food shall be consistent with the contents approved by the Ministry of Health.
8. Storage and transportation of finished products
8. 1 The general hygiene requirements for storage and transportation shall meet the requirements of gb 1488 1.
8.2 The storage mode and environment of finished products should be protected from light and rain, and the temperature and humidity should be controlled within a suitable range to avoid impact and vibration.
8.3 Products containing bioactive substances should be refrigerated and stored and transported by cold chain.
8.4 Health foods stored at extremely low temperature (such as some microecological health foods) should be stored and transported at the required temperature according to the different characteristics of the products.
8.5 The warehouse shall have a receiving and dispatching inspection system. The principle of "production first, sales first" should be implemented when finished products leave the factory.
8.6 Finished product warehousing should have inventory records; Finished products should have delivery records, including at least batch number, delivery time, place, object and quantity, so as to recover them in time when problems are found.
9. Quality management
9. 1 The factory must set up an independent quality management organization that is suitable for the production capacity and is directly led by the person in charge of the factory. Each workshop is equipped with full-time quality inspectors, and each team is equipped with part-time quality inspectors to form a complete and effective quality monitoring system, which is responsible for the quality supervision of the whole production process.
9.2 Formulation and implementation of quality management system
9.2. 1 The quality management organization must formulate a sound management system, including the following contents.
A) Management system for raw and auxiliary materials, intermediate products, finished products and nonconforming products;
B) Technical regulations on raw material identification and quality inspection, intermediate product inspection and finished product inspection, such as quality specifications, inspection items, inspection standards, sampling and inspection methods and other management systems;
C) sample observation system and laboratory management system;
D) Production process operation verification system;
E) license management system;
F) Management system for all kinds of original records and batch production records;
G) document management system.
9.2.2 The above management system should be practical and easy to operate and check.
9.3 It is necessary to set up inspection rooms and laboratories suitable for the types of products produced, with rooms, instruments, equipment and equipment required for inspection of raw materials, semi-finished products and finished products, and conduct regular appraisal to keep them in good condition.
9.4 Quality Management of Raw Materials
9.4. 1 quality inspectors must be set up according to the regulations of the state or relevant departments to identify and inspect the quality of raw materials batch by batch, and unqualified materials shall not be used.
9.4.2 Inspect and manage the storage places of raw materials, and the places with unqualified storage conditions shall not be used.
9.5 Quality Management of Processing Process
9.5. 1 Find out the key control points of quality and hygiene during processing, and at least monitor and record the following links.
9.5. 1. 1 feed name and weight (or volume).
9.5. 1.2 Technical parameters such as temperature, pressure, time and ph during the extraction of effective components.
9.5. 1.3 Output rate and quality specification of intermediate products.
9.5. 1.4 finished product output rate and quality specifications.
9.5. 1.5 Hygienic status of inner packaging materials in direct contact with food.
9.5. 1.6 technical parameters of finished product sterilization method.
9.5.2 Important production equipment and measuring instruments should be overhauled regularly. Thermometers and pressure gauges used in sterilization equipment should be overhauled at least once every six months, and maintenance records should be kept.
9.5.3 Should have the ability to monitor the production environment, and regularly monitor the temperature, humidity, air purity and other indicators of the key process environment.
9.5.4 Should have the ability to monitor production water, and conduct regular monitoring.
9.5.5 For the abnormal situations found in the quality management process, the reasons should be quickly found out and recorded, and corrected.
9.6 finished product quality management
9.6. 1 The finished products must be inspected for sensory, hygiene and quality indicators batch by batch, and those who fail shall not leave the factory.
9.6.2 Should have the ability to detect the main efficacy factors or components of products, and carry out detection according to the efficacy factors or main efficacy components of products produced by each feeding, and those who fail shall not leave the factory.
9.6.3 Samples shall be provided for each batch of products, which shall be stored in a special sample storage warehouse (or area), classified by variety and batch number, and clearly marked.
9.6.4 The product stability test shall be conducted regularly.
9.6.5 The packaging materials, signs and instructions of the products must be checked, and those who are unqualified shall not be used.
9.6.6 Check and manage the storage conditions of finished product warehouses, and warehouses that do not meet the storage conditions shall not be used.
9.7 Other requirements of quality management
9.7. 1 The user's quality comments and adverse reactions in use shall be recorded in detail, and the investigation and handling shall be done well, and the records shall be kept for future reference.
9.7.2 Complete quality management files must be established, with filing cabinets and file managers. All kinds of records should be classified and filed for 2 ~ 3 years for future reference.
9.7.3 Conduct a comprehensive inspection of production and quality on a regular basis, and verify the operation procedures and post responsibility system in production management. Adjust the problems found in inspection or verification, and report the production quality of products to the health administrative department regularly.
10 health management
The factory shall, in accordance with the requirements of gb 1488 1, do a good job in sanitary management such as pest control, treatment of toxic and harmful substances, animal feeding, sewage treatment and by-product treatment.
attachment
Review method and evaluation standard of good manufacturing practice for health food
In order to standardize the production of health food, improve the self-management level of health food enterprises, strengthen the health supervision and management of health food industry, and ensure the health of consumers, according to the Food Hygiene Law of People's Republic of China (PRC), the Measures for the Administration of Health Food, the General Hygiene Standard for Food Enterprises (gb 1488 1) and the Quality Management Standard for Health Food Production (gb
I. Contents of review
See the review form of good manufacturing practices for health food.
Second, the review process.
The review of the implementation of good manufacturing practices for health food (hereinafter referred to as gmp) by health food production enterprises is divided into two aspects: data review and on-site review, and the provincial health administrative department is responsible for organizing the implementation.
Specific according to the following procedures:
(1) filing an application
Health food production enterprises that meet or basically meet gmp requirements may apply to the health administrative departments of all provinces (autonomous regions and municipalities directly under the Central Government) for examination. When applying, the following materials shall be submitted:
1, application report;
2, health food production management and self-examination;
3. The management structure of the enterprise;
4. Copy of business license and health food approval certificate (not required for new factory);
5 formulations, production processes, quality standards and process flow charts of the main products of each dosage form;
6, enterprise full-time technical personnel introduction;
7. Catalogue of products and production equipment produced by the enterprise;
8, the general plan of the enterprise and the layout of each production workshop (including people flow, logistics, clean area division, clean air flow, etc.). );
9, inspection room personnel, facilities and equipment;
10, quality assurance system (including enterprise production management, quality management file directory);
1 1, technical parameter report of clean area (cleanliness, pressure difference, temperature and humidity, etc. );
12, other related information.
(2) Data review
The provincial health administrative department shall organize a data review of the application documents submitted by the enterprise within 15 working days. If it is considered that the applicant enterprise has met or basically met gmp requirements through data review, it shall notify the applicant enterprise in writing and arrange on-site review. If it is considered that the applicant enterprise does not meet the requirements for on-site review through data review, it shall also notify the applicant enterprise in writing and explain the reasons.
(3) on-site review
On-site inspectors should be health supervisors who have received gmp evaluation training. According to the Review Form of Good Manufacturing Practices for Health Food (Form 1), the examiner conducts on-site review of the enterprises under review, records the facts and situations found in the on-site review, and asks the accompanying personnel to confirm.
(4) issue a report on the results of gmp review.
The examiner shall summarize the results of the on-site review, and make a review conclusion on the gmp implementation of the enterprise under review within 5 working days after the on-site review. And report to the provincial health administrative department.
Three. criteria for evaluation
According to the influence of specific terms in gmp on product health and safety, the review method divides the review items into key items, key items and general items. Key projects refer to projects that have a significant impact on health food safety and hygiene, key projects refer to projects that have a greater impact on health food safety and hygiene, and other projects are general projects. Specific key items, key items and general items are marked in Table 1 Review Table of Good Manufacturing Practices for Health Food.
Gmp review results are evaluated according to Table 2.
Table 2 Decision Table of Review Results
※ review result item
Unqualified number of key projects (items) Unqualified number of key projects (items) Unqualified proportion of general projects (percentage) #
Operator 0
Basically meet (rectification within a time limit) 0 point.
03-5≤20%
#: The denominator of the unqualified proportion of general items is the total number of general items that are not applicable to the re-examination items.
Those that do not meet the requirements and basically meet the requirements will be deemed as unqualified. ※.