This standard in the preparation of engineering, part of the use of the "China Good Manufacturing Practice" (1992 Revision) on the content of the clean plant. In the preparation of the format and content, reference to the World Health Organization (who) "Drug Production Quality Management Code". In terms of general building design and health requirements, reference to gb 14881-1994 "food enterprises general health norms".
Since the specification belongs to the scope of food production, the requirements for practitioners, building facilities and document retention are lower than those of the Good Manufacturing Practice, but higher than those of the General Hygienic Norms for Food Factories.
This standard is formulated with full reference to the principles of Hazard Analysis Critical Control Points (haccp), and specific requirements have been put forward in some key aspects.
This standard is proposed by the Ministry of Health of the People's Republic of China **** and State.
This standard by the Ministry of Health Food Hygiene Supervision and Inspection is responsible for drafting; by the Fujian Provincial Food Hygiene Supervision and Inspection, Guangdong Province Food Hygiene Supervision and Inspection, Liaoning Provincial Food Hygiene Supervision and Inspection, Shenyang City, Shenyang City, Tianjin Municipal Health Disease Prevention Center, Fujian Fulong Biological Products Co.
The main drafters of this standard: Bao Dayue, Li Tairan, Lin Shengqing, Zhang Yonghui, Shi Gensheng, Xiao Dongsheng, Liu Changhui, Liu Hongde, Zheng Pengran, Sheng Wei.
This standard is entrusted by the Ministry of Health Food Hygiene Supervision and Inspection Institute of the Ministry of Health is responsible for interpretation.
1. Scope
This standard specifies the production of food with specific health functions of the enterprise's personnel, design and facilities, raw materials, production process, storage and transportation of finished products, as well as quality and health management of the basic technical requirements.
This standard applies to all health food production enterprises.
2. Citation Standards
The provisions contained in the following standards are cited in this standard and constitute the provisions of this standard. When this standard is published, the version shown are valid. All standards will be revised, the use of this standard parties should explore the possibility of using the latest version of the following standards.
gb j73-84 clean plant design specification
gb 5749-85 drinking water health standards
gb 7718-94 food labeling general standards
gb 14881-94 food enterprises general health norms
3. Definitions
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
Substances or mixtures that require further processing.
3.3 Product
Finished product to be sold after it has been shaped and packaged.
3.4 Lot number
A group of numbers or letters and numbers used to identify a "lot". It can be used to trace and review the production history of the batch of health food.
4. Personnel
4.1 Health food manufacturers must have with the production of health food compatible with the pharmaceutical (or biology, food science) and other relevant professional knowledge of the technical staff and management personnel with production and organizational capacity. The proportion of full-time technical personnel should not be less than 5% of the total number of employees.
4.2 The person in charge of the technology of the enterprise must have a college degree or higher or the corresponding education, and health food production and quality, health management experience.
4.3 The person in charge of the health food production and quality management department must be a full-time employee, should have a college degree or above or the corresponding academic qualification that is compatible with the profession he/she is engaged in, and be able to organize the production or carry out the quality management in accordance with the requirements of this specification, and have the ability to make the correct judgment and deal with the actual problems in the production and quality management of the health food products.
4.4 Health food production enterprises must have full-time quality inspection personnel. Quality inspection personnel must have secondary school education or above; purchasing personnel should have the knowledge and skills to identify whether the raw materials meet the quality and health requirements.
4.5 Practitioners must be educated before the health regulations and the corresponding technical training, the enterprise should establish training and assessment files, the person in charge of the enterprise and production, quality management department should also accept the provincial level or above, the health supervision department of health food professional training, and obtain a certificate of conformity.
4.6 Practitioners must undergo a health examination and obtain a health certificate before taking up their duties, and then a health examination must be conducted once a year.
4.7 Practitioners must do a good job of personal hygiene according to the requirements of gb 14881 "General Hygienic Standard for Food Enterprises".
5. Design and Facilities
5.1 Design
The overall design of the health food factory, the general design of the plant and facilities, the building and sanitary facilities shall comply with the requirements of gb 14881 "General Hygienic Norms for Food Enterprises".
5.2 Plant and Plant Facilities
5.2.1 The plant shall be reasonably arranged according to the production process and the required cleanliness level, and the production operations in the same plant and the neighboring plants shall not hinder each other.
5.2.2 must be in accordance with the production process and health, quality requirements, clean level, in principle, is divided into general production areas, 100,000 areas.
100,000 clean level area should be installed with filtering devices with the corresponding purification and air conditioning facilities.
Plant clean level and the number of air changes are shown in Table 1.
Clean level dust/m2 live microorganisms m2 air changes/h
≥ 0.5μm ≥ 5μm
0000 level ≤ 350000 ≤ 2000 ≤ 100 ≥ 20 times
00000 level ≤ 3500000 ≤ 20000 ≤ 500≥15 times
5.2.3 The design and installation of the clean room shall conform to the requirements of gb j73.
5.2.4 Clean level must meet the production and processing of health food on the need for air purification. Production of tablets, capsules, pills and oral liquid can not be sterilized in the last container should be used 100,000 clean plant.
5.2.5 plant, equipment layout and process flow should be reasonable convergence of the three, the building structure is perfect, and can meet the production process and quality, hygiene requirements; plant should have enough space and place to place equipment, materials; for intermediate products, to be packaged storage should be compatible with the production requirements.
5.2.6 Clean plant temperature and relative humidity should be compatible with the requirements of the production process.
5.2.7 Sewerage, hand-washing and other sanitary and cleaning facilities installed in the clean plant shall not bring pollution to the production of health food.
5.2.8 Buffer facilities should be provided between plants with different cleanliness levels and between plants and passages. Should be set up with the clean level of personnel and materials appropriate channel.
5.2.9 Pre-processing of raw materials (such as extraction, concentration, etc.) should be carried out in its production scale and process requirements of the appropriate place, and equipped with the necessary ventilation, dust removal, cooling facilities. Pre-processing of raw materials shall not be used with the production of finished products in the same production plant.
5.2.10 Health food production should be equipped with preparation room, preparation room cleanliness level should be consistent with the requirements of the production process.
5.2.11 Clean plant air purification facilities, equipment should be regularly overhauled, the overhaul process should take appropriate measures, and shall not cause pollution to the production of health food.
5.2.12 The production of fermented products should have a special fermentation workshop, and there should be fermentation, spray the corresponding special equipment.
5.2.13 Where the raw materials, intermediate products in direct contact with the production of tools and equipment should be used in line with product quality and health requirements of the material.
6. Raw materials
6.1 Health food production of raw materials needed for the purchase, use, etc. should be developed acceptance, storage, use, inspection and other systems, and is responsible for.
6.2 Raw materials must meet the requirements of food hygiene. Raw material varieties, sources, specifications, quality should be consistent with the approved formula and product enterprise standards.
6.3 Purchase of raw materials must be in accordance with the relevant provisions of the valid inspection report form; is a new source of food raw materials need to obtain the Ministry of Health approval certificate (copy).
6.4 Artificial fermentation of fungi produced by mycelium or mycelium and fermentation products of the mixture and micro-ecological raw materials must be obtained strain identification reports, stability reports and strains do not contain drug-resistant factor of the evidence.
6.5 Algae, animals and animal tissues and organs as raw materials, must obtain species identification report. A single effective substance extracted from animals and plants or biological or chemical compounds as raw materials, the physical and chemical properties of the substance should be requested and the content of the test report.
6.6 Raw materials containing stimulants or hormones, its content should be requested to test the report; by radioactive radiation of raw materials, should be requested to irradiation dose of the relevant information.
6.7 The transportation of raw materials should meet the health requirements. According to the characteristics of the raw materials should be equipped with appropriate insulation, refrigeration, freshness, rain and dust facilities to ensure quality and health needs. Transportation shall not be mixed with toxic, hazardous substances in the same car or the same container.
6.8 After the purchase of raw materials on the source, specifications, packaging for the initial inspection, according to the provisions of the acceptance system to fill in the storage account, card, storage should be applied to the quality inspection department for sampling and testing.
6.9 All kinds of raw materials should be inspected, qualified, unqualified partition off the ground storage, and have a clear sign; qualified spare should also be stored separately according to the different batches, the same library shall not be stored to affect each other's flavor of the raw materials.
6.10 temperature, humidity and special requirements of the raw materials should be stored in accordance with the specified conditions; general storage of raw materials or warehouse, the ground should be flat, easy to ventilate, rodent-proof, insect-proof facilities.
6.11 should be developed for the storage period of raw materials, using the principle of first-in-first-out. Unqualified or expired raw materials should be marked and dealt with early.
6.12 Mycelium produced by artificial fermentation of fungi or micro-ecological class as raw materials should be strictly control the conditions of preservation of strains, strains should be screened regularly, purification, identification when necessary to prevent contamination of stray bacteria, strain degradation and mutation of toxicity.
7. Production process
7.1 Development of production procedures
7.1.1 The factory should be in accordance with the requirements of this specification and combined with the characteristics of their own production process, the development of production process procedures and job operating procedures.
The production procedure should meet the process requirements of no loss, no destruction, no transformation and no generation of harmful intermediates of efficacy components in the processing of health food products, and its content 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 the key processes, such as: temperature, pressure, time, ph value, quality indexes of the intermediate products, etc. of the finished product processing process. Quality indexes of intermediate products, etc.
Post operating procedures should be the production of major processes to provide specific operational requirements, clear workshops, processes and individual job responsibilities.
7.1.2 The production technology and management personnel of the production workshop, according to the production process of the key process control items and inspection requirements, each batch of products from the preparation of raw materials, intermediate product output, product quality and hygiene indicators and other records.
7.2 Receipt and feeding of raw and auxiliary materials
7.2.1 Raw materials before production must be strictly inspected, check the name, specifications, quantity, for mold, insects, mixed with foreign matter or other sensory properties abnormal, not in line with the requirements of the quality standard shall not be put into production and use. Where the provisions of the storage period of the raw materials, the expiration date shall not be used. Liquid raw materials should be filtered to remove foreign matter; solid raw materials need to be crushed, sifted should be crushed to the required fineness.
7.2.2 Workshop according to the production needs to receive raw materials, according to the formula for the correct calculation, weighing and feeding, formula calculation of raw materials, weighing and feeding must be double-checked, record for inspection.
7.2.3 The water quality of production water must comply with the provisions of gb 5749, for special provisions of the process water, should be further purified according to process requirements.
7.3 Dosing and processing
7.3.1 Product dosing before the need to check the dosing pots and containers and pipes are clean, in line with the standards required by the process. Fermentation tanks, containers and pipelines used in the fermentation process must be thoroughly cleaned and sterilized before they are used for production. Each shift should be a good instrument cleaning, disinfection records.
7.3.2 Production operations should be articulated reasonably, transfer quickly and easily to prevent cross-contamination. Raw material handling, intermediate product processing, packaging materials and containers, cleaning, disinfection, packaging and inspection of finished products and other processes should be set up separately. The same workshop shall not produce different products at the same time; the containers of different processes should be clearly labeled, and shall not be mixed.
7.3.3 Production operators should be strictly in accordance with the different requirements of the general production area and clean area, good personal hygiene. Due to the transfer of jobs may lead to product contamination, must replace the work clothes, shoes, hats, re-sterilization. Used in the clean area of the work clothes, hats, shoes, etc. must be strictly cleaned, disinfection, daily replacement, and only allowed to wear in the clean area, not allowed to take out of the area.
7.3.4 Raw and auxiliary materials into the production area, you must enter through the material channel. Where the clean plant, workshop materials must be removed from the outer packaging, if the outer packaging can not be removed to be scrubbed clean or replaced with indoor packaging barrels.
7.3.5 Preparation process raw materials, auxiliary materials must be mixed evenly, the material needs to be hot melt, heat or concentration (evaporation) must be strictly controlled heating temperature and time. Intermediate products need to adjust the content, ph value and other technical parameters, adjusted by the content, ph value, relative density, preservatives and other re-measurement review.
7.3.6 The process operation should be in line with the process requirements of good condition. Oral liquid, beverages and other liquid products need to filter the production process, attention should be paid to the selection of non-fiber shedding and meet the health requirements of the filter material, prohibit the use of asbestos as a filter material. Capsule, tablet, punch and other solid products need to be dried should strictly control the temperature and time of the drying room (box) to prevent particles from melting and deterioration; mashing, pressing, sieving or granulation equipment should be selected to meet the hygiene requirements of the material production, and regular cleaning and maintenance to avoid rust and metal contaminants contamination.
7.3.7 Product compression, capsule filling, punch, filling of liquid products should be carried out in a clean room, should control the temperature and humidity of the operating room. Manual dispensing capsules should be carried out in the organic glass enclosure with the appropriate level of cleanliness, the operating table shall not be less than 0.7m.
7.3.8 The prepared material shall be placed in a clean airtight containers, and timely access to the filling, tablet pressing or dispensing capsules and other processes, which need to be stored shall not exceed the specified period.
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7.4.1 should be used in accordance with health standards and hygiene management practices allow the use of food containers, packaging materials, detergents, disinfectants.
7.4.2 The use of empty capsules, sugar coating and other raw materials must meet the hygiene requirements, prohibit the use of non-food coloring.
7.4.3 Product packaging with a variety of glass bottles (tubes), plastic bottles (tubes), caps, bottle cushions, stoppers, aluminum packaging materials, etc., where direct contact with the product of the internal packaging materials should be taken to the appropriate method of cleaning, drying and sterilization, sterilization should be placed in a clean room after cooling spare. Storage time exceeds the specified period should be re-washed, sterilized.
7.5 Product sterilization
7.5.1 All types of product sterilization should be selected using effective sterilization or sterilization equipment and methods. For products that need to be sterilized and cannot be sterilized by hot pressure, according to different processes and food hygiene requirements, use fine filtering, microwave, irradiation and other methods to ensure sterilization effect. Irradiation sterilization methods, should be in strict accordance with the "irradiation food hygiene management measures", strict control of irradiation absorption dose and time.
7.5.2 Should be sterilized or sterilized device temperature uniformity, repeatability and other regular reliability verification, temperature, pressure and other testing instruments regularly calibrated. In sterilization or sterilization operations should be accurately recorded temperature, pressure and time and other indicators.
7.6 Product filling or filling
7.6.1 Each batch of products to be filled or filled should be checked to see if the quality of the product meets the requirements, calculate the output rate, and check with the actual output rate. If there is a significant difference, the reason must be identified, after a reasonable explanation and to confirm that there is no potential quality incidents, approved by the quality management department can be treated as normal products.
7.6.2 Liquid product filling, solid product granulation, compression and filling should be carried out in accordance with the corresponding requirements in a clean area. In addition to capsules, the product filling, filling shall use automatic mechanical devices, do not use manual operation.
7.6.3 Filling equipment, needles, tubes, etc. should be checked before filling with fresh distilled water rinse clean, disinfected or sterilized.
7.6.4 The operator 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 quality of filling and sealing.
7.6.5 Where products need to be sterilized, the time from filling to sterilization should be controlled within the time limits required by the process regulations.
7.6.6 Oral ampoule preparations and straight glass bottles and other bottled liquid preparations should be lighted after filling. At the end of each batch of light test, must do a good job of clearing, rejected products should be labeled with the name, specifications, batch number, placed in a clean container to the person responsible for handling.
7.7 Packaging
7.7.1 Health food packaging materials and labels should be kept by a person, each batch of product labels issued by the instructions, receive, destroy the packaging materials should be recorded.
7.7.2 After the light test and inspection of qualified semi-finished products in the printing or labeling process, should be sampled at any time to check the quality of printing or labeling. Printed words should be clear; stickers should be affixed correctly and firmly.
7.7.3 Finished product packaging shall not be sandwiched between items unrelated to food.
7.7.4 Product packaging should be marked on the pressure (weight).
7.8 Labeling
7.8.1 Product labeling must comply with the "Regulations on Labeling of Health Food" and the requirements of gb 7718.
7.8.2 The printing of instructions and labels of health food products shall be consistent with the contents approved by the Ministry of Health.
8. Storage and transportation of finished products
8.1 The general health requirements for storage and transportation should be in accordance with the requirements of gb 14881.
8.2 Finished product storage and environment should be protected from light, rain, temperature, humidity should be controlled in the appropriate range, and avoid impact and vibration.
8.3 Products containing biologically active substances should be refrigerated accordingly and stored and transported in cold chain.
8.4 Health food products kept under non-conventional temperature (such as certain micro-ecological health food products) should be stored and transported according to different characteristics of the products and in accordance with the required temperature.
8.5 Warehouses should have receiving and shipping inspection system. Finished products should be carried out in the factory "first production, first sale" principle.
8.6 Finished goods should be stocked records; finished goods should be shipped out of the warehouse records, including at least the batch number, shipment time, location, object, quantity, etc., in order to find problems in a timely manner recovery.
9. Quality management
9.1 The factory must set up an independent quality management organization compatible with the production capacity, directly under the leadership of the person in charge of the factory. Each workshop set up a full-time quality inspector, each shift set up part-time quality inspector, forming a complete and effective quality control system, responsible for the quality of the entire production process supervision.
9.2 The development and implementation of quality management system
9.2.1 Quality management organization must develop a sound management system, quality management system should include the following.
a) raw and auxiliary materials, intermediate products, finished products and the management system of nonconforming products;
b) raw materials identification and quality inspection, inspection of intermediate products, finished products, inspection procedures, such as quality specifications, inspection items, inspection standards, sampling and testing methods, etc. management system;
c) retained samples of observation system and laboratory management system;
d) production process operation verification system;
e) clearing management system;
f) a variety of original records and batch production records management system;
g) file management system.
9.2.2 The above management system should be practical, easy to operate and check.
9.3 must be set up with the production of product types appropriate inspection room and laboratory, should have the raw materials, semi-finished products, finished products for the inspection of the necessary rooms, instruments, equipment and equipment, and regular identification, so that it is often in good condition.
9.4 Quality management of raw materials
9.4.1 must be in accordance with national or relevant departments to set up a quality inspector, batch by batch of raw materials for identification and quality inspection, unqualified shall not be used.
9.4.2 To check and manage the storage of raw materials, storage conditions do not meet the requirements of the premises shall not be used.
9.5 Quality management of the processing process
9.5.1 Identify the key control points of quality and hygiene in the processing process, and at least monitor the following links and keep records.
9.5.1.1 Name and weight (or volume) of the feeding material.
9.5.1.2 Temperature, pressure, time, ph and other technical parameters of the active ingredient extraction process.
9.5.1.3 The output rate and quality specifications of the intermediate product.
9.5.1.4 Output rate and quality specifications of the finished product.
9.5.1.5 Hygienic status of internal packaging materials in direct contact with food.
9.5.1.6 Technical parameters of the method of sterilization of the finished product.
9.5.2 To the important production equipment and measuring instruments for regular maintenance, used for sterilization equipment, thermometers, manometers at least half a year overhaul, and make maintenance records.
9.5.3 should have the ability to monitor the production environment, and regularly monitor the key process environment temperature, humidity, air purification and other indicators.
9.5.4 Should have the ability to monitor the production of water, and regular monitoring.
9.5.5 The abnormalities found in the quality management process, should quickly identify the causes and make records, and corrected.
9.6 Quality management of finished products
9.6.1 Batch by batch of finished products must be sensory, hygiene and quality indicators of the test, the unqualified shall not be shipped.
9.6.2 should have the ability to detect the main efficacy factor or efficacy components of the product, and the efficacy factor or the main efficacy components of the product produced by each feeding test, failures are not allowed to leave the factory.
9.6.3 Each batch of products should be retained samples, retained samples should be stored in a dedicated sampling library (or area), according to the variety, batch number categorized and stored, and have a clear sign.
9.6.4 Product stability tests should be done regularly.
9.6.5 The product packaging materials, signs, instructions must be checked, unqualified shall not be used.
9.6.6 Check and manage the storage conditions of the finished product warehouse, do not meet the storage conditions of the warehouse shall not be used.
9.7 Other requirements for quality management
9.7.1 Detailed records should be made of the quality opinions put forward by the users and the adverse reactions in the use, and do a good job of investigating and dealing with the work, and make a record for inspection.
9.7.2 Must establish a complete quality management files, with filing cabinets and file managers, all kinds of records are categorized and filed, save 2 to 3 years for inspection.
9.7.3 Production and quality should be regularly carried out a comprehensive inspection of the production and management of the operating procedures, job responsibility system to verify. Adjustments to the problems found in the inspection or verification, and regularly report to the health administrative department of the production quality of the product.
10. Health management
The factory should be in accordance with the requirements of gb 14881, do a good job of deworming, pest control, poisonous and harmful substances, animal husbandry, sewage treatment, by-products, such as health management. General Hygienic Standard for Food Enterprises" (gb14881) and "Good Manufacturing Practice for Health Food" (gb17405) to develop the review methodology and evaluation guidelines.
I. Content of the review
See "Health Food Good Manufacturing Practice Review Form".
Second, the review process
The health food manufacturer "Good Manufacturing Practice in Health Food" (hereinafter referred to as gmp) implementation of the review is divided into two aspects of the review of information and on-site review by the provincial health administrative departments responsible for the organization and implementation.
Specifically in accordance with the following procedures:
(a) Application
Health food manufacturers self-examination results that have been or basically meet the requirements of the gmp, can be to the provinces (autonomous regions and municipalities directly under the Central Government) health administrative departments to apply for review. When applying, the following information should be submitted:
1, application report;
2, health food production management and self-inspection;
3, the management structure of the enterprise;
4, a copy of the business license, health food approval certificate (new plants do not need to be provided);
5, the formula of the main products of each dosage form, production process and Quality standards, process flow chart;
6, the enterprise full-time technical personnel;
7, the enterprise's production of products and production equipment catalog;
8, the enterprise's general layout and the layout of the production plant floor plan (including the flow of people, logistics diagrams, clean areas divided into diagrams, purified air flow charts, etc.);
9, the inspection room personnel, facilities, Equipment;
10, quality assurance system (including enterprise production management, quality management documents catalog);
11, clean area technical parameters report (cleanliness, differential pressure, temperature and humidity, etc.);
12, other relevant information.
(B) information review
Provincial health administrative departments of the application documents submitted by the enterprise within 15 working days of the organization to review the information, through the information review that the applicant has been or basically meet the requirements of the gmp, notify the applicant in writing, you can arrange for on-site review. If through the information review that the applicant enterprise does not meet the conditions of the on-site review, should also be notified in writing to the applicant enterprise, and explain the reasons.
(C) on-site review
The on-site reviewers should be trained in certain gmp evaluation of health supervision personnel. Reviewers to "health food good manufacturing practice review form" (Table 1) as the basic basis for the review of the enterprise on-site review, for the on-site review of the facts and circumstances found should be recorded, and asked to accompany the staff to be confirmed.
(D) issued gmp review results report
The reviewers on-site review of the results of the summary, at the end of the on-site review of five working days, according to the "review results of the table" (Table 2) on the review of the implementation of the gmp review of the enterprise to make conclusions. And reported to the provincial health administrative departments.
Third, the evaluation guidelines
According to the gmp in the specific provisions of the degree of impact on the health and safety of the product, the review method will review the project is divided into key items, key items and general items. The key items refer to the items that have significant impact on the safety and health of health food products, the key items refer to the items that have greater impact on the safety and health of health food products, and the other items are general items. Specific key items, key items and general items are indicated in Table 1, "Health Food Good Manufacturing Practice Review Form".
gmp review results in accordance with Table 2 review results assessment.
Table 2 review results table
Review results * Item
The number of key items unqualified (item) the number of key items unqualified (item) the general items unqualified ratio (percentage)#
Compliance 0<3<20%
Basic compliance (deadline for rectification) 0<320%-30%
03-5≤20%
03-5≤20%
The review of the gmp review results in accordance with the "Good Manufacturing Practice Review Table" indicated. p> 03-5≤20%
#: The denominator of the percentage of general items failing is the total number of general items excluding those not applicable to the review.
*: Failure to meet the conditions of conformity and basic conformity is considered non-conformity.