This standard specifies the specifications that a good laboratory engaged in pesticide toxicological safety evaluation should comply with. This standard applies to pesticide toxicological safety evaluation tests conducted for pesticide registration applications. Good laboratories for pesticide toxicological safety evaluation must comply with this standard. NY/T 718-2003 Good Laboratory Procedures for Pesticide Toxicological Safety Evaluation NY/T718-2003 Standard download decompression password: www.bzxz.net

ICS 65.020.01
Agricultural Industry Standard of the People's Republic of China
NY/T718—2003
Good Safety Evaluation of Pesticide Toxicology
Laboratory Specifications
2003-12-01 Issued
Ministry of Agriculture of the People's Republic of China
2004-03-01 Implementation
This standard is proposed by the Market and Economic Information Department of the Ministry of Agriculture. This standard is under the jurisdiction of the Crop Production Management Department of the Ministry of Agriculture. The responsible drafting unit of this standard: Pesticide Testing Institute of the Ministry of Agriculture. Participating drafting units of this standard: Shenyang Chemical Industry Research Institute The main drafters of this standard: Yang Yongzhen, Ji Ying, Wang Jie, Song Hongyu, Wang Guolian, Liu Shaoren. NY/T718—2003
1 Scope
Good laboratories for pesticide toxicological safety evaluation
Laboratory specifications
This standard specifies the specifications that good laboratories engaged in pesticide toxicological safety evaluation should comply with. NY/T 718—2003
This standard applies to pesticide toxicological safety evaluation tests conducted for the purpose of applying for pesticide registration. Good laboratories for pesticide toxicological safety evaluation must comply with this standard.
2 Terms and definitions
The following terms and definitions apply to this standard. 2.1
Pesticide safety evaluation agency
A laboratory engaged in toxicological safety evaluation research for pesticide registration. 2.2
Commissioning unit
A unit that commissions a pesticide safety evaluation agency to conduct pesticide toxicological safety evaluation tests. 2.3
Safety evaluation
Various toxicity tests conducted with a test system to evaluate the safety of pesticides. 2.4
Test system
Animals, plants, microorganisms and cells used for toxicity tests. 2.5
Toxicity tests
Various tests on general toxicity, genetic toxicity, reproductive toxicity, etc. conducted in the laboratory to clarify the safety of the test substance. 2.6
Test substance
Pure pesticide, technical substance or its various preparations used in the test. 2.7
Control substance
Substances compared with the test substance in the test. 2.8
A group of numbers or letters and numbers used to identify the "batch" to ensure the traceability of the test substance or control substance. 2.9
Any material collected from the test system for analysis, observation and measurement. 2.10
Original data
Original records and relevant written materials of research work shall be recorded in the experiment, including observation records, notebooks, photos, negatives, chromatograms, microfilms, magnetic carriers, computer printouts, automated instrument recording materials, etc. 3 Organization and personnel
3.1 The pesticide safety evaluation agency shall be relatively independent, and its organization and management shall meet the requirements of this standard. It shall be equipped with the head of the agency, the head of the quality assurance department, the project leader and the corresponding test personnel. 3.2 The number and quality of personnel shall be consistent with the work undertaken. These personnel must undergo necessary education and training, have the corresponding technical knowledge and work experience, be competent for their duties, and obtain the qualifications for employment. 3.3 Measures and plans shall be in place to ensure that their personnel are trained in a timely manner. 3.4 Safety and health protection measures shall be taken to ensure that the test personnel are free from any contamination from the test, and measures shall also be taken to ensure that the physical condition of the test personnel does not affect the test.
3.5 Technical files such as academic certificates, qualification certificates, training and technical performance, work experience, authorization and appointment certificates of all technical personnel should be kept.
3.6 Test personnel of pesticide safety evaluation institutions should meet the following requirements: 3.6.1 Have a rigorous scientific style and good professional ethics. 3.6.2 Be familiar with the basic content of this standard, strictly perform their duties, master and strictly implement the standard operating procedures related to the work they undertake.
3.6.3 Record relevant phenomena and data in the test in a timely, accurate and clear manner, and report any situation that may affect the results of the test to the project leader in a timely manner.
3.6.4 Dress according to the needs of the job position, abide by the health examination system, and ensure that the test materials, control materials and test systems are not contaminated. 3.6.5 Conduct physical examinations regularly. Those with diseases that affect the research results shall not participate in research work. 3.7 The responsibilities of the person in charge of the pesticide safety evaluation institution are: 3.7.1 Be fully responsible for the construction and organizational management of the pesticide safety evaluation institution. 3.7.2 Decide on matters such as personnel deployment, promotion, rewards and punishments, and training. 3.7.3 Ensure that various facilities, equipment, and test conditions meet the requirements. 3.7.4 Ensure that there are sufficient staff members and perform their duties in accordance with the requirements. 3.7.5 Appoint the head of the quality assurance department and ensure that he or she performs his or her duties. 3.7.6 Appoint the project leader before each research project begins. 3.7.7 Responsible for signing the test agreement or letter of entrustment with the collaborating or entrusting unit. 3.7.8
Organize the formulation and revision of standard operating procedures to ensure that staff members master the relevant standard operating procedures. Formulate a master schedule to master the progress of various research projects. 3.7.9
3.7.10 Review and approve the test plan.
3.7.11 Handle the report of the quality assurance department in a timely manner and record the measures taken in detail. 3.7.12 Review and approve the test report.
3.8 The responsibilities of the head of the quality assurance department of the pesticide safety assessment agency are as follows: 3.8.1 Keep a copy of the master schedule, test plan and test report of the pesticide safety assessment agency 3.8.2 Review the test plan, test records and test report. 3.8.3 Carry out inspections on each study and formulate a review and inspection plan based on its content and duration. Record the content of the inspection, problems found, measures taken, etc. in detail, sign the record and keep it for future reference. 3.8.4 Regularly inspect animal breeding facilities, test instruments and file management. 3.8.5 Report problems found and suggestions in the inspection to the head of the agency and (or) the project leader in writing. 3.8.6 Participate in the formulation of standard operating procedures and keep a copy of the standard operating procedures. 3.9 The responsibilities of the project leader are as follows:
3.9.1 Be fully responsible for the implementation and management of the project. 2
Formulate a test plan, strictly implement the test plan, analyze the research results, and write a test report. 3.9.2
Implement the provisions of the standard operating procedures and make timely suggestions for revision or supplement. 3.9.3
Ensure that the staff involved in the project are clear about the work they are responsible for and master the corresponding standard operating procedures. 3.9.4
Master the progress of the project and check various test records at any time to ensure timeliness, directness, accuracy and clarity. 3.9.5
Record in detail the unexpected situations that occurred during the test and the remedial measures taken. 3.9.6
Deal with the issues raised by the quality assurance department in a timely manner to ensure that all aspects of the research work meet the requirements. 3.9.7
NY/T718—2003
3.9.8After the test, the test plan, original data, specimens to be preserved, various relevant record documents and test reports shall be archived and preserved.
4 Quality Assurance Department
4.1 An independent quality assurance department shall be set up to supervise each project or subject and ensure that the management of facilities, equipment, personnel, methods, operations, records and controls complies with the requirements of this standard. The quality assurance department shall conduct inspections and keep inspection records truthfully. 4.2 Responsibilities of the Quality Assurance Department:
4.2.1 Keep copies of all master schedules undertaken by the organization. Keep copies of the test project agreements or letters of entrustment of the organization. 4.2.2
4.2.3 Develop a test inspection plan and conduct inspections according to the plan and standard operating procedures to ensure the correctness and completeness of the project. Keep records of inspections, which should be signed. Record the date of the inspection, project name, inspected department, inspector, problems, suggestions or solutions to the problems, and the timetable for re-inspection. Problems found during the inspection should be notified to the project leader and the head of the organization in a timely manner, and a written inspection report on the relevant project should be submitted.
4.2.4 Review the test plan of the project and keep a copy of it. 4.2.5 Review the test report to ensure that the results of the report accurately reflect the original data. 4.2.6 Sign a quality assurance statement, which includes the inspection time and content. 4.2.7 Keep relevant inspection records during the quality assurance process. 5 Test facilities
5.1 Establish corresponding test facilities according to the needs of the research content. Various test facilities should be kept clean and operate normally; the layout of various facilities should be reasonable to prevent cross contamination; environmental conditions and their regulation should meet the requirements of different facilities. 5.2. Equipped with animal breeding facilities with reasonable design and proper configuration, and capable of regulating environmental conditions such as temperature, humidity, air cleanliness, ventilation and lighting as required. The conditions of experimental animal facilities should be consistent with the level of experimental animals used. Animal breeding facilities mainly include the following aspects:
5.2.1 Breeding and management facilities for animals of different species or different experimental systems. 5.2.2 Animal quarantine and isolation and treatment facilities for sick animals. 5.2.3 Facilities for collecting and disposing of experimental waste. Cleaning and disinfection facilities.
When the test and control materials contain volatile, radioactive and biohazardous substances, corresponding breeding facilities should be set up. 5.2.5
5.3 Equipped with storage facilities for feed, bedding, cages and other animal supplies. The configuration of various facilities should be reasonable to prevent mutual contamination with the experimental system. Animal supplies that are easily rotten and deteriorated should have appropriate storage measures. 5.4 Equipped with facilities for handling test and control materials 5.4.1 Facilities for receiving and storing test and control materials. 5.4.2 Preparation and storage facilities for test and control substances. 5.5 Establish corresponding laboratories according to work needs; special laboratories should be established when using biologically hazardous animals, microorganisms, radioactive materials, etc.
5.6 Have facilities for keeping test plans, various specimens, original records, test reports and related documents and archives. 3
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5.7 Equip corresponding environmental control facilities according to work needs. 6 Instruments and test materials
6.1 Instruments and equipment that meet test and environmental requirements should be equipped. 6.1.1 Instruments and equipment should be maintained in accordance with the prescribed procedures: a) The daily inspection, cleaning, maintenance, use and calibration of instruments and equipment should be specified in detail. Instruments and equipment used to generate or evaluate data should be fully tested and calibrated, and measures should be taken when abnormal situations occur. b)
Specified persons should be assigned to be responsible for instruments and equipment.
All inspections, maintenance, use and calibration should be recorded in writing. When equipment fails, there should be a repair record, which should explain the type, cause and treatment of the failure. c)
Instruments and equipment should have obvious markings to indicate their calibration status. 6. 1.3
Preserve instrument and equipment files, including: a)
Instrument name, model, number:
Manufacturer name;
Instrument receipt date and status and commissioning date; instruction manual;
Calibration/verification date and results (certificate) and the date of the next calibration/verification; records of damage, failure and repair;
Usage record.
6.2 Management of test and control materials:
Test and control materials are kept by designated personnel, with complete procedures for receipt, registration and distribution, and records of the entrusting unit, entrusting person's name, test and control material name, quantity, physical and chemical properties, packaging and precautions. 6.2.2 The containers for test and control materials should be labeled with the product name, code, batch number, quantity, validity period and storage conditions. 6.2.3 When test and control materials are distributed and received, the product name and batch number should be checked, the date should be noted, and the parties should sign after their agreement. 6.2.4 When the test and control materials are mixed with the medium, the uniformity and concentration of the mixture should be measured before the test, and the stability should be measured if necessary. 6.3 The reagents and solutions in the laboratory should be labeled with the product name, concentration, preparation date and validity period. Deteriorated or expired reagents and solutions should not be used.
6.4 According to the relevant regulations on experimental animals, select experimental animals that meet the requirements. 6.5 The use of cleaning agents, disinfectants and pesticides shall not affect the test results, and the name, concentration, method of use and time of use shall be recorded. Animal feed, bedding and drinking water should be disinfected and sterilized, and inspected regularly, and the inspection results shall be kept as original data. 7 Standard Operating Procedures
7.1 Standard operating procedures should be formulated to ensure the standardization of the test process and the accuracy and completeness of the data. Any deviation from the standard operating procedures during the test should be authorized by the project leader, and major deviations should be approved in writing by the head of the institution. 7.2 Standard operating procedures should at least include the following: 7.2.1 Editing and management of standard operating procedures. 7.2.2 Quality assurance procedures.
7.2.3 Control of test facilities and environmental conditions. 7.2.4 Control of animal breeding facilities and environmental conditions. 7.2.5 Management of animals and test supplies.
7.2.5.1 Methods for receiving, collecting, labeling, storing, handling, mixing feed and sampling of test and control materials. 7.2.5.2 Transportation, quarantine, numbering, identification, housing, placement, transfer and feeding management of test animals. 7.2.6 Symptom observation and test operation of test animals. 7.2.7 Methods for collecting, measuring, testing and analyzing various specimens. 7.2.8 Instrument and equipment management, maintenance, verification and calibration. Purchase and acceptance of equipment and various test supplies. 7.2.9
7.2.10 Inspection and treatment of dying and dead animals. Animal anatomy and pathological histological examination.
Management of laboratory reagents and solutions.
3 Test records and data processing.
7.2.14 Preparation, review and approval of test reports. 5 Use and management of computers.
Personnel training, assessment, appointment and health examination. 7. 2. 16
7.2.17 Preparation of test plans.
7.2.18 Management of documents, archives and specimens. NY/T 718—2003
7.3 Standard operating procedures shall take effect after being signed and confirmed by the quality assurance department and approved by the head of the institution. Expired standard operating procedures shall be destroyed in a timely manner except for one copy kept on file.
7.4 The development, modification, effective date, distribution and destruction of standard operating procedures should be recorded and filed. 7.5 Standard operating procedures and other quality documents should be kept valid and easy to use. Any operation that deviates from the standard operating procedures during the research process should be approved by the project leader and recorded. Changes to standard operating procedures should be confirmed by the head of the quality assurance department and approved in writing by the head of the institution.
7.6 All versions of standard operating procedures should be kept. 8 Experimental plan and implementation of the experiment
8.1 The project leader should formulate the experimental plan, which will be implemented after review by the quality assurance department and approval by the head of the institution, and approved by the entrusting unit when necessary.
8.2 The experimental plan should generally include the following contents: 8.2.1 Test items, test numbers and test purposes. 8.2.2 Names, codes, batch numbers and physical and chemical properties of the test and control substances. 8.2.3 Names and addresses of the entrusting unit and the test unit. 8.2.4 Project leader and test participants. Start date and end date of the experiment. 8.2.5
8.2.6 Reasons for the selection of the test system.
Animal strain, age, sex, weight range, number and source.
Grouping and identification methods of test animals.
Environmental conditions of test animals.
Solvents for test or control substances.
Preparation of test substances.
Route of administration and its reasons.
Dosage, method, frequency and duration of administration of test and control substances. Items and frequency of observation, inspection, analysis and measurement during the test. Statistical processing methods.
Storage location of data and specimens. bzxZ.net
8.2.17Signatures of the head of the institution and the project leader. 5
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8.3Changes to the test plan shall be reviewed by the quality assurance department and approved by the head of the institution. If necessary, they shall be approved by the entrusting unit. The content, reasons and date of the changes shall be filed together with the original test plan. 8.4 The project leader is fully responsible for the operation and management of the project. Participants in the experiment should work strictly in accordance with the test plan and standard operating procedures. If any abnormal or unexpected phenomenon occurs during the experiment, the project leader should be reported in time and detailed records should be kept. If there is a change in personnel during the experiment, they should be replaced according to the procedure. 8.5 The test record should be made in a fixed format, and the name or code of the test project should be used uniformly. All data should be recorded in a timely, direct, accurate, clear and not easily erased, and the date and signature should be indicated. When the recorded data needs to be modified, the original record should be kept clear and legible, and the reason for the modification and the modification date should be indicated, and the modifier should sign.
8.6 Various specimens collected during the experiment or containers for specimens should be marked with the name or code of the test project, the number of the test animal and the date of collection.
8.7 When animals develop diseases not caused by the test article or abnormal conditions that interfere with the purpose of the study, they should be isolated or killed immediately. When drug treatment is required, it should be approved by the project leader, and the reason for treatment, approval procedures, examination conditions, drug prescriptions, treatment dates and results, etc. should be recorded in detail. Treatment measures must not interfere with the research. 9 Test report
9.1 The test report should include the following contents: 9.1.1 Table of contents, abstract, introduction, materials and methods, results and discussion, conclusions, attached tables, references, etc. 9.1.2 Test title, code, name and address of the commissioning unit and the test implementation unit, start and end date of the test, and unique number of the test report.
9.1.3 Name, code, batch number, purity, content, concentration, stability, and number of the test and control substances (according to the test plan). 9.1.4 Animal species, strain, grade, age, sex, weight, number, source, purchase date, and breeding conditions. 9.1.5 Basis for design of route, dose, method, number, duration, and amount of administration. 9.1.6 Environmental factors that may affect data quality. 9.1.7 Frequency and method of observation items and measurement indicators. 9.1.8 Statistical methods for analyzing and processing data. 9.1.9 Discussion and conclusion of test results.
Name and title of the project leader and test personnel related to the test. When part of the test is carried out by other units, there should be another test report with signature and date. 9.1.11
9.1.12 Long-term tests should have water quality analysis reports and feed analysis reports tested by special institutions. 9.1.13 Storage place of original data, reports and specimens. Statement signed by the quality assurance department.
The date of completion of the final report.
9.1.16 Signatures of the project leader, the head of the quality assurance department and the head of the institution. 9.2 If the report still needs to be modified or supplemented after being approved and signed by the head of the institution, the project leader must submit the content and reasons for the modification in writing, which shall be reviewed by the quality assurance department and approved by the head of the institution. 10 Storage of materials and specimens
10.1 After the test is completed, the project leader must send the original records of the relevant test, the test plan, the test report, the inspection report of the quality assurance department and other materials to the data storage room, and keep them in accordance with the requirements of the standard operating procedures, and facilitate retrieval. 10.2 The test specimens shall be delivered to the specimen storage room for safekeeping in a timely manner. 10.3 The information and specimen storage room shall be assigned a dedicated person, and borrowing of materials shall be subject to the approval of the head of the institution. 6
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10.4 From the date of registration, the test report and original records shall be kept for at least 5 years; the specimen storage period is generally 5 years, and if it exceeds the period, it shall be negotiated with the client. 10.5 During the storage period, attention shall be paid to the quality of the stored materials. The storage period of easily deteriorating specimens (such as tissue organs, electron microscope specimens, blood smears, etc.) shall be limited to the time limit for quality evaluation.
10.6 Technical files of staff members, instrument and equipment files, etc. shall generally be kept for a long time.
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