Some standard content:
ICS 07.100
National Standard of the People's Republic of China
GB15193.2—2003
Replaces GB15193.2—1994
Good laboratory practice for food toxicology2003-09-24 Issued
Ministry of Health of the People's Republic of China
Standardization Administration of the People's Republic of China
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2004-05-01 Implementation
GE15193.2-2003
The full text of this standard is mandatory.
This standard replaces GB15193.2-1994 "Good laboratory practice for food toxicology". Compared with GB15193.2-1994, this standard has been modified as follows: a) The words "safety" and "evaluation\" have been added; b) "should be avoided and reduced as much as possible" has been changed to "avoid or reduce"; c) 10.1 Requirements for experimental animals have been added; in the "General animal room management requirements", d)
-The daily temperature difference should not exceed "2℃～4℃" has been changed to "3℃", and the temperature requirements for various animals have been changed from "18℃～25℃" to "20℃～25℃"
The indoor relative humidity should be preferably "40%～80%" to "40%～70%"; There should be no abnormally strong odor in the animal room, mainly caused by the ammonia smell produced by animal excrement, and its concentration should be controlled within \20 mg/kg\below is changed to \14mg/m3"below. From the date of implementation of this standard, GB15193.2-1994 will be abolished at the same time. This standard is proposed and managed by the Ministry of Health of the People's Republic of China. Drafting units of this standard: Nutrition and Food Safety Institute of China Center for Disease Control and Prevention, Nanjing Medical College, Zhejiang Provincial Health and Epidemic Prevention Station. Main drafters of this standard: Yang Ying, Cao Laifu, Ma Fenglou, Zhao Shuo, Yu Qiang. This standard was first issued in 1994 and this is the first revision. 10
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1 Scope
Food Toxicology Laboratory Operation Specifications
This standard specifies the requirements for food toxicology laboratories (including experimental animal rooms) GB15193.2- 2003
This standard applies to units that are qualified to conduct food safety toxicological evaluation tests approved by the health administrative department. 2 Normative referenced documents
The clauses in the following documents become the clauses of this standard through reference in this standard. For any dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For any undated referenced documents, the latest versions shall apply to this standard. GB5749 Sanitary Standard for Drinking Water
3 Terms and Definitions
The following terms and definitions apply to this standard. 3.1
Test substancetest substances
Various test samples within the "scope" of this specification. 3.2
Test system
3.2.1All animals, microorganisms and other organisms treated with test substances and reference substances. 3.2.2Tests conducted in accordance with food toxicology requirements, including the methods used. 3.3
reference materials
Substances used in the test system to identify the biological characteristics of the test organisms and the sensitivity and specificity of the test system, as well as substances used to compare with the test substances when judging the results in the test system. 3.4bZxz.net
specimen
All test substances used for testing and items taken out of the test system for inspection or analysis are called specimens. 3.5
rawdata
Records of experiments and various activities observed during the experimental research, including all experimental records and data, records on automatic analysis and testing instruments, photos and audio-visual records, originals or copies, etc. 3.6
Study initiation and completion dateThe date when the study director signs the test plan is the study start date, and the date when the final test result report is signed is the test completion date. 3.7
Program director
Responsible for the review and approval of the relevant project design or concurrently as the project director. 3.8
Project directorProject director
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GB 15193.2—2003
Responsible for the design of the project or sub-project, the technical measures of the test, the interpretation of the test, the analysis and drafting of relevant documents and test reports, and the proof of the quality control of the experiment.
Quality control officerFood toxicology experts and relevant personnel other than the project director are responsible for the control of the quality of the experiment. 4 Personnel and Organization
4.1 Personnel
4.1.1 Experimental personnel must be well educated and trained, have certain work experience, be competent for the corresponding work, have a rigorous scientific attitude and a high sense of responsibility.
4.1.2 Experimental personnel must pay attention to personal hygiene to avoid contaminating the test substances, control substances and test systems. 4.1.3 Experimental personnel must wear specific work clothes suitable for the nature of their work. These work clothes must prevent the experimenters from being contaminated by the test substances, control substances and test systems, and should be replaced appropriately. 4.1.4 Once the experimenter is found to have a disease that has an adverse effect on the quality of the experiment, he must be prohibited from directly contacting all test substances, control substances and test systems until the disease is cured. If the health of the experimenter affects the quality of the experiment, it must be reported to the experiment leader and the subject leader immediately and necessary measures must be taken to ensure the quality of the experiment. 4.1.5 All experimenters must be clear about the content of their own work and their respective responsibilities. 4.2 Organization
4.2.1 The project leader shall propose a comprehensive test plan, which shall be signed by the test leader. 4.2.1.1 Determine the participants and division of labor of the project. 4.2.1.2 Implement the test plan.
4.2.1.3 Once an unexpected situation that affects the quality and reliability of the experiment is found, appropriate corrective measures must be taken immediately and records must be kept. 4.2.2 A quality assurance system composed of experts with rich experience other than the project leader shall be responsible for monitoring the experiment and ensuring that the equipment, instruments, personnel, methods, operations, records and quality control comply with this specification. 4.2.3 According to the test plan, human resources, financial resources, equipment, materials and methodology are fully guaranteed to ensure the timely and accurate completion of the research projects specified in the experimental design.
4.2.4 The project leader is responsible for the analysis and interpretation of the project data and the drafting of relevant documents and test reports. 4.2.5 Archive the data of the entire test process.
5 Laboratory
5.1 Test and measurement equipment
5.1.1 The laboratory should be equipped with equipment that meets the test and measurement requirements. The equipment should be placed reasonably to facilitate operation, inspection, cleaning and maintenance. 5.1.2 Records should be kept for each test and measurement device, and the records should include: the name of the device;
manufacturer and model mark;
receipt date;
activation date;
power supply installation;
maintenance details;
latest verification and calibration date.
5.1.3 The operating instructions of each test and measurement device should be properly kept and should be easily accessible. The experimental equipment should only be operated by personnel approved to engage in such work.
5.1.4 If any part of the device is overloaded, used improperly, or the result is suspicious, or is determined to be defective by verification and other methods, it should be stopped from use, repaired and recorded for filing. If it is a measuring device, it should also be used after verification and calibration. 5.2 Inspection methods and procedures
GB15193.2—2003
5.2.1 The experimental unit shall have a written manual of the standard operating procedures that explain the correct operation, inspection, adjustment and arrangement of the machine, as well as the repair procedures to be taken when the machine fails or breaks, so that the staff can consult and use it. Any changes to the prescribed standard operating procedures shall be approved in writing by the competent department. 5.2.2 Reagents and solutions
5.2.2.1 All reagents and solutions in the experimental area shall be labeled with their properties, concentrations, storage requirements and expiration dates, and special reagents shall be stored in designated containers.
5.2.2.2 Deteriorated or expired reagents and solutions cannot be used. 5.2.2.3 Reagents and solutions (especially dangerous goods) should be properly stored to prevent contamination and deterioration when weighing and using, and maintain the specific properties of reagents and solutions.
5.2.2.4 The amount and date of receiving and taking out reagents should be recorded and archived. 5.2.3 Test and control substances
5.2.3.1 Characteristics of test and control substances
Indicators reflecting the characteristics of test and control substances such as component content, concentration, purity, stability and synthesis method of test and control substances should have complete information and be archived. If the test and control substances are commercially available, this should be noted. 5.2.3.2 Management of test and control substances
5.2.3.2.1 The window used to store test and control substances should be marked with the name, batch number, expiration date and storage conditions. 5.2.3.2.2 The properties and collection date of the test substance should be indicated and consistent with the label of the specimen container and other results. 5.2.3.2.3 The specimens and their observation records should be properly preserved to facilitate further research. The preservation of specimens should meet the relevant requirements for the preservation of record materials.
5.2.3.3 Mixture of test substance, control substance and vehicle 5.2.3.3.1 The mixture of test substance, control substance and vehicle should meet the test requirements. The vehicle used should not interfere with the characteristics of the test substance or control substance in the mixture, the test system, the implementation of the procedure and the test results. 5.2.3.3.2 The uniformity of the test substance and control substance in the mixture should be determined, and the concentration and stability of the test substance and control substance in the mixture should be determined regularly.
5.2.3.3.3 In a mixture of test substance, control substance and carrier, if any component has an expiration date, this should be indicated on the container; if two or more components have expiration dates, the earlier one should be indicated. 6 Design and implementation of test plan
6.1 Design plan
6.1.1 Each test should have a written design plan, including: a) the name of the test project and the purpose of the study;
the source of the test project;
the name and address of the test unit;
justification of the test project;
the test system used;
identification of the test system;
the name, model, range and measurement items of the test and measuring devices used; the dose, route and frequency of administration of the test substance and control substance, or the mixture of the test substance, control substance and carrier; h)
test records;
the measures to be taken in case of inconsistent results or abnormal conditions; j)
the proposed statistical method;
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GB 15193.2—2003
1) Precautions to be taken to ensure the safety of experimental personnel and prevent other losses. 6.1.2 After the design plan is approved, any changes and their reasons shall be signed by the person in charge of the experiment, with the date indicated, and filed together with the original plan.
6.2 Implementation of the test
6.2.1 The implementation of the test shall be carried out according to the design plan. 6.2.2 The specimens obtained during the test shall be marked with their properties and collection date, and shall be consistent with the labels of the specimen containers and other records. 6.2.3 The specimens and their observation records shall be properly preserved for further research. The preservation of specimens shall meet the relevant requirements for the preservation of record materials.
7 Records and data
7.1 Except for the data obtained by the automatic analysis and testing system, all observations and calculations shall be recorded clearly with an ink pen immediately, signed and dated by the recorder; any changes to the recorded data shall indicate the reason, change date and signature. The data obtained by the automatic analysis and testing system shall be signed and dated by the operator; when the data recorded by the automatic analysis and testing system is changed, it shall be approved by the person in charge of the test, and the reason and date of change shall be noted and signed.
7.2 Preservation of records and data
7.2.1 All original data, documents, design plans, specimens (except wet specimens such as blood, urine, stool, body fluids, etc.), interim reports and general reports obtained from the test shall be archived and indexed for easy reference. 7.2.2 Records and data shall have a designated storage location and be managed by the person in charge of the archives. Prior approval shall be obtained for accessing the archives. 7.2.3 Records and data shall be retained for at least 2 years, but shall be considered in accordance with the actual circumstances. For example, if they are used for litigation, provide legal basis, or are related to the inspection of new raw materials and new products that have not yet been approved, they may be extended to 5 years. 8 Test report
8.1 The work completed by the laboratory shall have a comprehensive test report. The test report shall accurately and objectively state the test results and all relevant circumstances.
8.2 The test report should include the following:
a) The name and address of the laboratory, the start and end dates of the test; b) A unified test report serial number;
c) The test report should indicate the page number;
d) The name of the unit submitting the test;
e) The description, identification mark and receipt date of the test product; f) The test method and procedure;
g) The statistical method used for data analysis; h) The test results and conclusions;
i) The name of the project leader, the names of all other personnel involved in the inspection and the management personnel: i) The signature and date of the relevant personnel responsible for verifying the test report. 8.3 The general report should be signed and dated by the person in charge of the test. 8.4 When the general report needs to be modified or supplemented, the person in charge of the test should be responsible for clarifying the parts that need to be modified or supplemented, stating the reasons, signing and indicating the date.
9 Environment
9.1 The environmental conditions of the laboratory should meet the requirements of its testing work. 9.2 The laboratory should take appropriate measures to ensure good management. 9.3 The disposal of experimental supplies and waste should meet relevant regulations and requirements. 14
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10 Experimental Animals and Animal Houses
10.1 Requirements for Experimental Animals
The selection of experimental animals shall be carried out in accordance with the relevant national regulations on the management of experimental animals and specific experimental methods. 10.2 Requirements for Housing Facilities for Experimental Animals
GB 15193.2--2003
10.2.1 The housing facilities for experimental animals should be separated into independent buildings. Including staff dressing and bathing rooms, animal feeding rooms, washing and disinfection rooms, feed storage rooms, bedding storage rooms and isolation and quarantine rooms. Feces, sewage, used bedding, animal bodies and waste should have safe disposal measures. Animals with special requirements, such as sterile animals, animals without special pathogens, purebred animals and nude mice, should have buildings and equipment that meet specific requirements, strict hygiene management systems and operating procedures. 10.2.2 There should be a sufficient number of animal rooms or areas as needed. 10.2.2.1 Animals should be raised separately according to their species, strains or different sources. 10.2.2.2 Animals should be raised separately according to different research projects. 10.2.2.3 For test substances known to have biological hazards (including volatile substances, radioactive substances, infectious factors and substances with "three-hazard" hazards), there must be special animal rooms or areas that can be used for isolated tests to prevent environmental pollution. 10.2.3 Animal room facilities should have good ventilation and drainage channels. The indoor facades are smooth and equipped with rodent-proof, insect-proof and cooling and cold-proof facilities.
10.2.4 Breeding rooms or laboratories for large experimental animals such as cats, dogs, and monkeys should have appropriate exercise areas, reliable wire mesh or high walls and double-layer door facilities to prevent animals from escaping.
10.2.5 There should be at least 20m of sanitary separation around experimental animal rooms of a certain scale. 10.3 General animal room management requirements
10.3.1 The temperature of the animal room should be kept relatively constant, with a daily temperature difference of no more than 3℃. The temperature requirements for various animals are: 20℃～25℃.
10.3.2 The relative humidity in the room should be 40%~~70%. 10.3.3 High-frequency noise should be avoided, the noise should be controlled within 60dB, and ultrasonic interference should be avoided. 10.3.4 There should be no abnormally strong odor in the animal room, mainly ammonia odor produced by animal excrement, and its concentration should be controlled below 14mg/m.
10.3.5 The animal room should be kept tidy, the animal cages should not be too crowded, and the number of animals in each cage should not be too large. Animals for feeding experiments should be kept in individual cages so that the intake can be calculated more accurately. 10.3.6 Smoking is prohibited in the animal room.
10.3.7 Miscellaneous items not related to the experiment should not be placed in the animal breeding room. 10.4 Animal management requirements
10.4.1 When animals are purchased from breeding animal rooms or from outside units, it is necessary to verify whether the animals meet the relevant management requirements (breed, animal grade, etc.).
10.4.2 All animals newly received from the outside should be isolated, and their health status should be evaluated. They should be observed for at least 3 days, and the experiment can only be started after it is confirmed to be normal.
10.4.3 The purchase of animals must be the responsibility of a dedicated person in the research team, who must register and record the handling process. This includes the number of animals, sex, weight range, source of supply, genus, species, subspecies and age. 10.4.4 Animals used for research must be properly marked (such as tattoos, color coding, ear tags, ear piercings, etc.). During the research, each animal cage must have a record card.
10.4.5 Normal and experimental animals that have been killed should be sent out of the animal room in a timely manner and handled as required. Animals with severe toxic (including carcinogenic) substances and animals treated with such substances should be placed in designated places and destroyed in a timely manner. 10.5 Health protection requirements
10.5.1 Quarantine of experimental animals and control and treatment of diseases 15
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10.5.1.1 All foreign experimental animals must undergo at least 3 days of quarantine to prevent the invasion of infectious diseases. Only animals with no signs of disease (necessarily undergoing laboratory tests with negative results) can enter the breeding room. 10.5.1.2 Before conducting food toxicology studies, it is necessary to ensure that the animals are free of any disease and to avoid contact with factors that may affect the purpose of the study and its implementation. If during the study, animals are diagnosed with a disease or exposed to a factor, the sick animals must be isolated. If necessary, and the treatment does not affect the study, the animals can be treated. The diagnosis, approval of animal treatment, drugs used for treatment, measures and dates of treatment must be recorded and preserved.
10.5.1.3 Animals that die of disease should be promptly examined by pathology or other laboratory tests, and a diagnosis or treatment opinion should be given. In principle, all animals should be destroyed when they have infectious diseases. Housing, utensils, cages, bedding, clothing, etc. must be thoroughly disinfected. The animal room can only be used after being sealed for a period of time. If necessary, report to the person in charge of the experiment and the competent department. 10.5.1.4 When a severe infectious disease occurs in experimental animals, it should be reported to the Laboratory Animal Testing Center immediately, and strict isolation and disinfection measures should be taken to prevent the spread of infectious diseases. If there is a delay in reporting, the unit and individual shall bear responsibility. 10.5.1.5 Body treatment: Body treatment generally requires burning and deep burial. Large animals can be disinfected and processed before use. 10.5.2 Feed and feeding hygiene
10.5.2.1 In order to ensure the nutrition and health of experimental animals and ensure the quality of animals, nutritious, clean and fresh complete feed must be supplied to experimental animals. The animal room in the first hall should have animal feeds of various formulas that meet the requirements. The finished products should be placed in plastic barrels and the maximum storage time should not exceed two months. If placed in a low-temperature storage warehouse, the storage period can be appropriately extended. Prevent contamination by wild mice, insects, chemicals and pesticides. 10.5.2.2 Fresh feed, fruits, milk, and beef must be refrigerated (4℃～8℃), and fresh vegetables must be washed and dried before use. 10.5.2.3 Feed that is rotten, moldy, has an unreasonable formula, has been in contact with toxic drugs, has not been sterilized and steamed, and other animal leftovers should not be fed to animals, otherwise it may cause disease or death. 10.5.2.4 Clean and sufficient drinking water should be provided to animals. The drinking water must meet the requirements of GB5749. The water supply utensils must be kept hygienic. The water bottles should be cleaned and disinfected regularly to prevent blockage or leakage of water pipes. 10.5.2.5 The feed and drinking water used by animals should be analyzed regularly to ensure that the pollutants that may exist in these feeds and drinking water and are known to affect the research results do not exceed the levels specified in the design. These analysis data should be kept as original data. 10.5.3 Utensil hygiene
10.5.3.1 Animal cages and auxiliary equipment must be scrubbed and disinfected after use and properly stored. 10.5.3.2 The source of bedding should meet the requirements and be disinfected when necessary. 10.5.3.3 For rodents, the bedding (mat) should be changed at least three times a week (every other day), and the bottom plate should be cleaned. Generally, it should be disinfected every 2 weeks or 4 weeks, and once a week if necessary. 10.5.3.4 The cages should be cleaned regularly, and scrubbed and disinfected if necessary. 10.5.3.5 The equipment, tables and floors in the animal room should be cleaned and scrubbed daily. 10.5.3.6 The containers of toxic substances, especially highly toxic and carcinogenic feeds, must be destroyed in time at the end of the experiment, and the operating utensils should be disinfected.
10.5.4 Health protection for staff
10.5.4.1 There are special clothes, hats, gloves, shoes, etc. in the animal room. Staff must change these special clothes when entering and leaving the animal room. Generally, they should be changed and washed once a week, and they can be changed and disinfected at any time under special circumstances. 10.5.4.2 Wash hands before and after contact with animals (disinfect if necessary), especially after cleaning, before meals and after defecation, and when contacting two different animals or more than two test subjects at the same time. 10.5.4.3 Workers should wear masks when they have a mild cold and should try to avoid or reduce direct contact with animals. People with severe colds or other infectious diseases are prohibited from entering the animal room until they recover. All experimental personnel’s health conditions must be reported to the relevant personnel at the next higher level if they affect the quality of the experiment.
10.5.4.4 Keep the doors and windows of the animal room closed at all times, and prevent the animals from escaping when handling animals and opening and closing cage doors. If an animal escapes, the person involved must be responsible for capturing and handling it.
Food Forum Friends Exchange Information2 The source of bedding should meet the requirements and be disinfected when necessary. 10.5.3.3 For rodents, the bedding should be changed at least three times a week (every other day) and the bottom plate should be cleaned. Generally, it should be disinfected every 2 to 4 weeks, and once a week if necessary. 10.5.3.4 The cages should be cleaned regularly and scrubbed and disinfected when necessary. 10.5.3.5 The equipment, tables and floors in the animal room should be cleaned and scrubbed daily. 10.5.3.6 The containers of toxic substances, especially highly toxic and carcinogenic feeds, must be destroyed in time at the end of the experiment, and the operating utensils should be disinfected.
10.5.4 Staff health protection
10.5.4.1 There are special clothes, hats, gloves, shoes, etc. in the animal room. Staff must change these special clothes when entering and leaving the animal room. Generally, they should be changed and washed once a week. In special circumstances, they can be changed and disinfected at any time. 10.5.4.2 Wash hands before and after contact with animals (disinfect if necessary), especially after cleaning, before meals and after defecation, and when contacting two different animals or more than two test subjects at the same time. 10.5.4.3 Workers should wear masks when they have a mild cold and should try to avoid or reduce direct contact with animals. People with severe colds or other infectious diseases are prohibited from entering the animal room until they recover. All experimental personnel’s health conditions must be reported to the relevant personnel at the next higher level if they affect the quality of the experiment.
10.5.4.4 Keep the doors and windows of the animal room closed at all times, and prevent the animals from escaping when handling animals and opening and closing cage doors. If an animal escapes, the person involved must be responsible for capturing and handling it.
Food Forum Friends Exchange Information2 The source of bedding should meet the requirements and be disinfected when necessary. 10.5.3.3 For rodents, the bedding should be changed at least three times a week (every other day) and the bottom plate should be cleaned. Generally, it should be disinfected every 2 to 4 weeks, and once a week if necessary. 10.5.3.4 The cages should be cleaned regularly and scrubbed and disinfected when necessary. 10.5.3.5 The equipment, tables and floors in the animal room should be cleaned and scrubbed daily. 10.5.3.6 The containers of toxic substances, especially highly toxic and carcinogenic feeds, must be destroyed in time at the end of the experiment, and the operating utensils should be disinfected.
10.5.4 Staff health protection
10.5.4.1 There are special clothes, hats, gloves, shoes, etc. in the animal room. Staff must change these special clothes when entering and leaving the animal room. Generally, they should be changed and washed once a week, and they can be changed and disinfected at any time under special circumstances. 10.5.4.2 Wash hands before and after contact with animals (disinfect if necessary), especially after cleaning, before meals and after defecation, and when contacting two different animals or more than two test subjects at the same time. 10.5.4.3 Workers should wear masks when they have a mild cold and should try to avoid or reduce direct contact with animals. People with severe colds or other infectious diseases are prohibited from entering the animal room until they recover. All experimental personnel's health conditions must be reported to the relevant personnel at the next higher level if they affect the quality of the experiment.
10.5.4.4 Close the doors and windows of the animal room at all times, and prevent the animals from escaping when handling animals and opening and closing cage doors. If an animal escapes, the person involved must be responsible for capturing and handling it.
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