Â Â Â In the preparation of this standard, part of the "China Pharmaceutical Manufacturing Quality Management Standards" (1992 revised edition) on the clean room is adopted. In terms of the format and content, the World Health Organization (WHO)'s "Management standards for the quality of pharmaceutical production" was used. For general architectural design and hygiene requirements, refer to GB 14881-1994 "General Sanitary Code for Food Enterprises".
As the specification is within the scope of food production, the requirements for employees, construction facilities, and document retention are lower than the quality control standards for pharmaceutical production, but higher than the "General Hygiene Code for Food Plants."
In the formulation of this standard, full reference has been made to the HACCP principles and specific requirements have been put forward in some key links.
This standard is proposed by the Ministry of Health of the People's
This standard was drafted by the Food Hygiene Supervision and Inspection Institute of the Ministry of Health; Food Safety Supervision and Inspection Institute of Fujian Province, Food Hygiene Supervision and Inspection Institute of Guangdong Province, Food Hygiene Supervision and Inspection Institute of Liaoning Province, Shenyang Sanitation and Epidemic Prevention Station, and Tianjin Health and Disease Prevention Center. 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 be responsible for the interpretation of the Ministry of Health Food Health Supervision and Inspection.
This standard stipulates the basic technical requirements for the production of personnel, design and facilities, raw materials, production processes, storage and transportation of finished products, and quality and hygiene management of food enterprises with specific health functions.
This standard applies to all health food production enterprises.
2 Reference standards
The provisions contained in the following standards are incorporated into this standard and constitute the provisions of this standard. At the time of publication, the editions indicated were 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 Clean Factory Design Specification
GB 5749-85 Sanitary standard for drinking water
GB 7718-94 General Standard for Food Labeling
GB 14881â€”94 General Sanitary Code for Food Enterprises
This standard uses the following definition.
3.1 Raw materials
All inputs used in the production of health food products, including processing aids and food additives.
3.2 Intermediate Products
Materials or mixtures that require further processing.
Formed packaging products to be sold.
3.4 Batch number
A set of numbers or letters plus numbers used to identify "batch." It can be used to trace and review the production history of the batch of health food.
4.1 Health food production companies must have technical personnel with relevant expertise in medicine (or biology, food science) and management personnel with production and organizational capabilities that are compatible with the health foods they produce. The proportion of full-time technical staff should not be less than 5% of the total number of employees.
4.2 The person-in-charge of the company in charge of technology must have a college degree or equivalent, and has experience in the production and quality of health food products and hygiene management.
4.3 The responsible person of the health food production and quality management department must be a full-time staff, should have a college degree or a corresponding academic qualification that suits the profession he is engaged in, be capable of organizing production or quality management in accordance with the requirements of this specification, and have the ability to The actual problems that arise in production and quality management make correct judgments and handling.
4.4 Health food production companies must have full-time quality inspection personnel. Quality inspectors must have a secondary school education or above; procurement personnel should have the knowledge and skills to identify raw materials for quality and hygiene requirements.
4.5 The employees must be trained in hygiene regulations and corresponding technical training before starting employment. The company shall establish training and assessment files. The person-in-charge of the company and the person in charge of production and quality management departments shall also receive professional training on health food products at the provincial or higher health supervision department. And obtain a certificate of conformity.
4.6 Employees must carry out health checks and obtain health certificates before they can take up posts. After that, they must undergo a health check every year.
4.7 Employees must perform personal hygiene in accordance with the requirements of GB 14881 â€œGeneral Sanitary Code for Food Enterprisesâ€.
5 Design and Facilities
The general design, plant and facility general design, construction and sanitation facilities of the health food factory shall comply with the requirements of GB 14881 "General Sanitary Code for Food Enterprises".
5.2 Plant and factory facilities
5.2.1 The factory building shall be rationally laid out according to the production process and the required cleanliness level. The various production operations performed in the same factory building and adjacent factory building shall not interfere with each other.
5.2.2 The cleanliness level must be classified according to the production process, hygiene and quality requirements. In principle, it should be divided into the general production area and the 100,000 class area.
The 100,000 class clean area should be equipped with the corresponding purification air-conditioning facilities with filter devices.
The cleanliness level and number of air changes in the factory are shown in Table 1.
Air change times/h
5.2.3 The design and installation of clean workshop should meet the requirements of GB J73.
5.2.4 The purification level must meet the need for air purification in the production and processing of health foods. Production of tablets, capsules, pills, and oral liquids that cannot be sterilized in the final container should use a class 100,000 clean room.
5.2.5 The layout of the plant and equipment and the process flow should be connected properly, the building structure should be perfect, and the production process, quality and hygiene requirements should be met; the factory building should have enough space and place for the placement of equipment and materials; The storage room for products and packages should be compatible with the production requirements.
5.2.6 The temperature and relative humidity of the clean room should be compatible with the production process requirements.
5.2.7 Sewers, hand-washing and other sanitary cleaning facilities installed in clean workshops shall not cause pollution to the production of health foods.
5.2.8 Buffer facilities shall be provided between workshops, workshops and passages with different cleanliness levels. Personnel and material channels that are compatible with cleanliness levels should be set separately.
5.2.9 The pre-treatment of raw materials (such as extraction, concentration, etc.) shall be carried out in a place that is compatible with its production scale and process requirements, and equipped with the necessary ventilation, dust removal, and cooling facilities. The pretreatment of raw materials must not use the same production plant as the finished product.
5.2.10 Health food production should be equipped with a stock room. The cleanliness level of the stock room should be consistent with the production process requirements.
5.2.11 The air purification facilities and equipment of clean workshops shall be regularly inspected and overhauled. Appropriate measures shall be taken during the inspection and shall not cause any pollution to the production of health foods.
5.2.12 Production Fermentation products should have special fermentation workshops, and special equipment corresponding to fermentation and spray should be provided.
5.2.13 All production tools and equipment that come in direct contact with raw materials and intermediate products shall use materials that meet product quality and hygiene requirements.
6 raw materials
6.1 The procurement, storage, use, and inspection of raw materials needed for the production of health food products shall be formulated and accepted by special personnel.
6.2 Raw materials must meet food hygiene requirements. The varieties, sources, specifications, and quality of raw materials should be consistent with the approved formula and product company standards.
6.3 Procurement of raw materials must be in accordance with relevant regulations to obtain an effective inspection report; raw materials that are new sources of food need to obtain a Ministry of Health approval certificate (photocopy).
6.4 The mycelium or mixture of mycelium and fermentation products obtained by artificial fermentation and the microecological raw materials must be obtained from the strain identification report, stability report, and proof materials that the strain does not contain drug resistance factors.
6.5 The species identification report must be obtained from algae, animal and animal tissues and organs as raw materials. If a single effective substance extracted from a moving plant, plant, or biological or chemical composition is used as a raw material, a test report on the physical and chemical properties and the content of the substance shall be obtained.
6.6 Raw materials containing stimulants or hormones should be obtained from their content test reports; raw materials that have been irradiated with radiation should be requested for relevant information on the dose of radiation.
6.7 The transportation of raw materials, etc. should meet the hygiene requirements. According to the characteristics of raw materials, it should be equipped with appropriate insulation, cold storage, preservation, rain and dust prevention facilities to ensure quality and health needs. The transportation process must not be mixed with toxic or harmful items in the same vehicle or in the same container.
6.8 After the purchase of raw materials, conduct a preliminary inspection of the source, specifications, and packaging, fill in the account and card in accordance with the acceptance system, and apply to the quality inspection department for sample inspection.
6.9 All kinds of raw materials shall be stored on the floor, which is to be inspected, qualified or unqualified, with obvious signs; qualified spares shall also be stored separately according to different batches, and 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 in accordance with the specified conditions; general storage places or warehouses of raw materials shall be leveled on the ground to facilitate ventilation and ventilation, as well as rodent-proof and insect-repellent facilities.
6.11 The storage period of raw materials should be established and the principle of first-in, first-out should be adopted. For unqualified or expired raw materials should be marked and dealt with early.
6.12 The mycelia obtained by artificial fermentation of fungi or micro-ecological as raw materials should be strictly controlled for the preservation conditions of the strains. The strains should be screened and purified regularly, and identified when necessary to prevent the contamination of bacteria and the degradation of bacteria. Mutations produce toxins.
7 production process
7.1 Formulate Production Operating Procedures
7.1.1 The factory shall formulate production process regulations and post operating procedures in accordance with the requirements of this specification and in combination with the characteristics of the production process of its own products.
The production process specification shall meet the technical requirements for no loss, non-destruction, non-transformation and non-harmful intermediates during the processing of health food products. The contents shall include the formulation of the product, the preparation of each component, and the main technical conditions of the finished product processing process. And the quality and hygiene monitoring points of key processes, such as: temperature, pressure, time, pH value, quality indicators of intermediate products during the processing of finished products.
The operational procedures shall provide specific operational requirements for each major production process, and define the job responsibilities of each workshop, process, and individual.
7.1.2 The production technology and management personnel of each production workshop shall record each batch of products from raw material preparation, intermediate product output, product quality and health indicators in accordance with the key process control items and inspection requirements during the production process. .
7.2 Collection and feeding of raw materials
7.2.1 The raw materials before being put into production must undergo a rigorous inspection to verify the product name, specifications, and quantity. For mildew, insects, mixed foreign bodies, or other abnormal sensory properties, which do not meet the quality standards, they must not be put into production. Raw materials that have a shelf life are not allowed to be used after they expire. The liquid raw materials should be filtered to remove foreign matter; solid raw materials must be crushed and sieved should be crushed to the required fineness.
7.2.2 The workshop shall receive raw and auxiliary materials according to production needs, and calculate, weigh and feed materials according to the formula. The calculation, weighing and feeding of formula raw materials shall be reviewed by two persons and recorded for future reference.
7.2.3 The quality of the production water must meet the requirements of GB 5749. For the special process water, it should be further purified according to the process requirements.
7.3 Ingredients and Processing
7.3.1 Before the product ingredients, it is necessary to check whether the pots and containers of the ingredients are clean and meet the standards required by the process. Fermentation tanks, containers, and pipes used in the fermentation process must be thoroughly cleaned and disinfected before they can be used in production. Every shift should be cleaned and sanitized.
7.3.2 The production operation should be connected properly, and the transfer is quick and convenient to prevent cross-contamination. Raw materials processing, intermediate product processing, packaging materials and container cleaning, disinfection, finished product packaging, and inspection should be set separately. The same workshop may not produce different products at the same time; containers of different processes shall be clearly marked and shall not be mixed.
7.3.3 The production operator should do a good job of personal hygiene in strict accordance with the different requirements of the general production area and the clean area. When the exchange of jobs may result in product contamination, uniforms, shoes, and caps must be replaced and re-disinfected. The uniforms, caps, and shoes used in the clean area must be strictly cleaned, disinfected, replaced daily, and only allowed to be worn in the clean area, and must not be brought out of the area.
7.3.4 Raw materials entering the production area must be entered through the material channel. All materials entering clean workshops and workshops must be removed from the outer packaging. If the outer packaging cannot be removed, it must be cleaned or replaced by an indoor packaging drum.
7.3.5 The raw and auxiliary materials must be mixed evenly in the preparation process. The heating temperature and time must be strictly controlled when the material needs to be hot melted, heated or concentrated (evaporated). Intermediate products need to adjust the technical parameters such as content, pH, etc. After adjustment, the reassessment of the content, pH value, relative density, preservatives, etc. must be reassessed.
7.3.6 Each process operation shall be performed in a good condition in accordance with the process requirements. The production process of liquid products such as oral liquids and beverages needs to be filtered. Care should be taken in the selection of filter materials that are free of fibers and that are in compliance with sanitary requirements. The use of asbestos as a filter material is prohibited. Solid products such as capsules, tablets, and granules that need to be dried should be strictly controlled in the temperature and time of the drying room (box) to prevent melting and deterioration of the particles; materials that meet hygiene requirements should be selected for mashing, pressing, sifting or sizing equipment. Production, and regular cleaning and maintenance to avoid rust and metal contamination.
7.3.7 The product tableting, sub-packing capsules, granules, filling of liquid products, etc. shall be performed in a clean room. The temperature and humidity of the operating room shall be controlled. Manual sub-packing should be carried out in a plexiglass hood with a corresponding clean grade, and the operating table must not be less than 0.7m.
7.3.8 The prepared material shall be placed in a clean, airtight container and timely filled into the processes of filling, compressing or sub-packing the capsule. The stored material shall not exceed the prescribed time limit.
7.4 Washing, Sterilizing and Cleaning of Packaging Containers
7.4.1 Food containers, packaging materials, detergents and disinfectants that are allowed to be used in accordance with the hygienic standards and hygiene management regulations shall be used.
7.4.2 The raw materials such as empty capsules and icings used must meet hygienic requirements and non-food colorings must not be used.
7.4.3 All kinds of glass bottles (tubes), plastic bottles (tubes), bottle caps, bottle mats, cork stoppers, and aluminum-plastic packaging materials used for product packaging shall be cleaned by appropriate methods for all inner packaging materials directly contacting the product. Dry and sterilize, after sterilization, should be placed in a clean room for cooling. Storage time exceeds the specified period should be re-washed and sterilized.
7.5 Product Sterilization
7.5.1 Sterilization of various types of products should use effective sterilization or sterilization equipment and methods. For products that need to be sterilized but not autoclaved, fine filtration, microwaves, irradiation, etc. can be used according to different processes and food hygiene requirements to ensure sterilization. When radiation sterilization methods are used, the irradiation dose and time should be strictly controlled according to the provisions of the â€œRegulatory Measures for Irradiated Food Hygieneâ€.
7.5.2 Periodically verify the reliability of the temperature uniformity and reproducibility of the sterilization or sterilizing device, and periodically check the temperature, pressure, and other testing instruments. In the sterilization or sterilization operation, the temperature, pressure, and time should be accurately recorded.
7.6 Product Filling or Filling
7.6.1 Each batch of products to be filled or filled shall be checked for its quality to meet the requirements, the yield rate shall be calculated and checked against the actual output rate. If there is a significant difference, the cause must be identified. After a reasonable explanation is obtained and no potential quality accident is confirmed, the quality management department may approve the normal product treatment.
7.6.2 Filling of liquid products. Granulation, tableting and filling of solid products shall be carried out in the clean area in accordance with the relevant requirements. In addition to capsules, the filling and filling of products must use automatic mechanical devices and manual operations must not be used.
7.6.3 Before filling, check whether the filling equipment, needles, pipes, etc. are rinsed, sterilized or sterilized with fresh distilled water.
7.6.4 The operator must constantly check the quality of the semi-finished product after filling and sealing, and adjust the filling (sealing) machine at any time to ensure the quality of the potting.
7.6.5 For products requiring sterilization, the time from potting to sterilization shall be controlled within the time limit required by the process specification.
7.6.6 The light inspection shall be conducted after potting the liquid preparations such as oral ampoule preparations and straight glass bottles. After the end of each batch of lamp inspections, clearance work must be done. The rejects should be marked with the product name, specifications, batch number, and placed in a clean container to be handled by a dedicated person.
7.7.1 Packaging materials and labels for health foods shall be kept by special persons. Each batch of product labels shall be issued and received by instruction, and the destroyed packaging materials shall be recorded.
7.7.2 During the process of printing or labeling semi-finished products that have passed the light inspection and inspection, the quality of printing or labelling shall be checked at any time. Printing should be clear; sticker should be posted and posted firmly.
7.7.3 No items unrelated to food shall be placed in the finished product packaging.
7.7.4 The maximum pressure (weight) shall be marked on the outer packaging of the product.
7.8.1 The product identification must comply with the "Health Food Labeling Regulations" and GB 7718 requirements.
7.8.2 Printing of health food product specifications and labels shall be consistent with the contents approved by the Ministry of Health.
8 Product Storage and Transportation
8.1 The general hygienic requirements for storage and transportation shall comply with the requirements of GB 14881.
8.2 The storage method and environment of finished products should be protected from light and rain, and the temperature and humidity should be controlled within an appropriate range to avoid impact and vibration.
8.3 Products containing biologically active substances should be used for appropriate refrigeration and stored and transported in a cold chain.
8.4 Health foods preserved at very low temperatures (such as certain micro-ecological health foods) should be stored and transported at the required temperature according to their different characteristics.
8.5 The warehouse shall have a collection and delivery inspection system. Finished products should implement the principle of "first production first".
8.6 The inventory of finished products shall have stock records; the finished products shall have a shipping record, and the contents at least include the batch number, shipping time, place, object, quantity, etc., so that problems can be recovered in time.
9 Quality Management
9.1 Factories must set up independent quality management agencies that are in line with their production capabilities and be directly under the leadership of the factory heads. All workshops are staffed with full-time quality inspectors, and each team has a part-time quality inspector to form a complete and effective quality monitoring system, responsible for the quality supervision of the entire production process.
9.2 Formulation and Implementation of Quality Management System
9.2.1 Quality management agencies must formulate a sound management system. Quality management systems should include the following.
a) Management systems for raw materials, intermediate products, finished products and non-conforming products;
b) Management of raw material identification and quality inspection, inspection of intermediate products, inspection of finished products, such as quality specifications, inspection items, inspection standards, sampling and inspection methods;
c) Retention observation observation system and laboratory management system;
d) production process operation verification system;
e) clearance management system;
f) various original records and batch records management systems;
g) file management system.
9.2.2 The above management system should be practical, easy to operate and check.
9.3 The laboratory and laboratories must be set up to suit the type of product produced. The room, equipment, equipment, and equipment necessary for the inspection of raw materials, semi-finished products, and finished products shall be provided, and they shall be regularly identified so that they are always in good condition.
9.4 Quality Management of Raw Materials
9.4.1 The quality inspection personnel must be established in accordance with the regulations of the state or relevant departments, and the raw materials shall be identified and quality checked on a batch basis. Those who are unqualified may not use the products.
9.4.2 The place where the raw materials are to be inspected and managed shall not be used in places where the storage conditions do not meet the requirements.
9.5 Process Quality Management
9.5.1 Find out the key quality and hygiene control points in the process of processing, and at least monitor the following steps and make records.
188.8.131.52 The name and weight (or volume) of the feed.
184.108.40.206 Technical parameters such as temperature, pressure, time and pH in the extraction process of active ingredients.
220.127.116.11 Intermediate product output rate and quality specifications.
18.104.22.168 Product output rate and quality specifications.
22.214.171.124 The hygienic condition of the inner packaging material in direct contact with the food.
126.96.36.199 Technical parameters of the product sterilization method.
9.5.2 Periodic inspection and maintenance of important production equipment and measuring instruments shall be carried out. Thermometers and pressure gauges used for sterilization equipment shall be overhauled at least once every six months, and maintenance records shall be made.
9.5.3 The ability to monitor the production environment shall be available, and the indicators such as temperature, humidity, and air purification degree shall be regularly monitored in key process environments.
9.5.4 The ability to monitor production water should be available and monitored regularly.
9.5.5 The abnormalities found in the quality management process should be quickly identified and documented and corrected.
9.6 Quality Management of Finished Products
9.6.1 The finished product must be tested for sensory, hygiene and quality indicators on a batch basis. Those who are unqualified cannot leave the factory.
9.6.2 The product shall have the ability to detect the main efficacy factors or functional components of the product, and shall test the efficacy factors or the main functional components of the products produced by each feeding. Those who fail shall not be allowed to leave the factory.
9.6.3 Each batch of products should be retained. Samples should be stored in a special sample retention warehouse (or district), stored according to the variety and batch number, and marked.
9.6.4 Product stability tests should be conducted periodically.
9.6.5 The product's packaging materials, signs, and instructions must be inspected. Unqualified persons must not use the product.
9.6.6 Checking and managing the storage conditions of the finished warehouses shall not be used in warehouses that do not meet the storage conditions.
9.7 Other Requirements for Quality Management
9.7.1 It shall deal with the quality comments made by users and the detailed records of adverse reactions that occur during use, and do a good job of investigation and handling, and make records for future reference.
9.7.2 A complete quality management file must be established. There should be a file cabinet and file management personnel. All records should be classified and archived and kept for 2 to 3 years for future reference.
9.7.3 A comprehensive inspection of production and quality shall be carried out on a regular basis, and all operating procedures and post responsibility systems in production and management shall be verified. Adjust the problems found during inspections or verifications and report the quality of production to the health administrative department on a regular basis.
10 Health Management
The factory shall, in accordance with the requirements of GB 14881, do a good job in the health management of insect removal, extermination, poisonous and harmful material treatment, animal feeding, sewage and soil treatment, and by-product processing.
annexHealth Food Good Manufacturing Practices Review Methods and Evaluation Criteria
In order to standardize the production of health foods, improve the self-management level of health food enterprises, increase the health supervision and management of the health food industry, and protect the health of consumers, it is based on the â€œFood Hygiene Law of the People's Republic of Chinaâ€ and the â€œMeasures for the Management of Health Foodâ€. This review method and evaluation criteria are formulated in "General Sanitary Regulations for Food Enterprises" (GB14881) and "Good Manufacturing Practices for Health Foods" (GB17405).
First, review content
See "Health Foods Good Manufacturing Practices Review Form."
Second, the review process
The review of the implementation of the â€œHealthy Food Good Manufacturing Practicesâ€ (hereinafter referred to as GMP) of health food production enterprises is divided into data review and on-site review. The provincial health administrative department is responsible for organizing the implementation.
Specifically follow the procedure below:
(a) to apply
If the health food production enterprise self-inspection results believe that it has met or basically meets the GMP requirements, it may apply to the provincial (autonomous region, municipality directly under the central government) health administrative department for review. When applying, the following information should be submitted:
1. Application report;
2. Health food production management and self-examination;
3, the company's management structure;
4. Copy of the business license and health food approval certificate (the new factory does not need to provide);
5, the formulation of the main products of each dosage form, production process and quality standards, process flow chart;
6. Introduction of full-time technical personnel of the company;
7. Catalogue of products and production equipment produced by enterprises;
8. The general plan of the company and layout plans of the production workshops (including the flow of people, the logistics diagram, the division map of the clean area, the flow chart of the purified air, etc.);
9. Introduction of laboratory personnel, facilities and equipment;
10. Quality Assurance System (including enterprise production management and quality management document catalog);
11, clean area technical parameters report (cleanliness, pressure, temperature and humidity, etc.);
12, other relevant information.
(II) Data review
The provincial health administrative department organizes the data review within 15 working days for the application documents submitted by the enterprises. If it is considered that the applicants have met or basically met the GMP requirements through written data review, the applicants may notify the applicants in written form that they can arrange on-site inspections. If it is considered through the data review that the applicant company does not meet the on-site examination requirements, it shall also notify the applicant in writing and explain the reasons.
(III) On-site examination
On-site auditors should be health supervisors who have been trained in GMP evaluation. The reviewers use the â€œHealthy Foods Good Manufacturing Practices Review Formâ€ (Table 1) as the basic basis to carry out on-site inspections of the enterprises under review. The facts and conditions found during the on-site review should be recorded and the follow-up personnel should be required to confirm them.
(IV) Issue GMP review result report
The reviewers will summarize the results of the on-site review and, within 5 working days after the end of the on-site review, make a review of the GMP implementation of the company under review in accordance with the â€œExamination Result Determination Formâ€ (Table 2). And reported to the provincial health administrative department.
Third, the evaluation criteria
In accordance with the degree of impact of the specific provisions of the GMP on the health and safety of products, this review method will be divided into key items, key items and general items. Key items refer to items that have a major impact on the safety and health of health foods. Key items refer to items that have a greater impact on the health and safety of health foods. Other items are general items. The specific key items, key items, and general items are indicated in Table 1, "Health Foods Good Manufacturing Practices Inspection Form."
The GMP review results are evaluated according to Table 2.
Table 2 Examination Result Determination Table
Review result â€»
Key item unqualified number (item)
Number of unqualified items (items)
General item disqualification rate (percentage)#
Basic conformity (limited time rectification)
#: The denominator of the general item non-conformity ratio is the total number of general items except for the non-applicable examination items.
â€»: If it does not meet the requirements and basically meets the conditions, it is inconsistent.
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