Some standard content:
ICS 65.20
Agricultural Industry Standard of the People's Republic of China
NY/T1906—2010
Good Laboratory Practice for Pesticide Environmental Testing2010-07-08Promulgated
2010-09-01Implementation
Ministry of Agriculture of the People's Republic of China
This standard is in accordance with the standard of (13/T1.12009) and is proposed and managed by the Crop Production Management Department of the Ministry of Agriculture. The responsible drafting unit of this standard is the Pesticide Testing Institute of the Ministry of Agriculture. The participating units of this standard are: Shenyang Chemical Research Institute, the main drafters of this standard are: Tao Chuanjiang, Cai Leiming, Shan Zhengnian, Qu Guan, Zhang Shanying, Jiang Hui, Ji MingNY/T1906—2010||t t||1 Scope
Good Laboratory Practice for Pesticide Environmental Evaluation
This standard specifies the good laboratory practice that pesticide environmental evaluation test cases should follow. This standard applies to environmental evaluation tests conducted to provide data for pesticide registration. 2 Terms and Definitions
The following terms and definitions apply to this document. 2.1
Test ItemsStudy
A test conducted to provide data for pesticide registration. 2.2
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Good Laboratory Practice laboratorypractice Quality system for the design, implementation, review, record keeping, documentation and reporting of test items and test conditions. 2.3
Pesticideenvironmentalevaluation Systematic analysis and evaluation of the physical, chemical or biological effects of pesticides on the environment and the environmental changes caused, and the possible impacts on human health and quality of life.
Testsitefestsite
Refers to the test site of a certain stage or multiple stages of a test project. 2.5
Testfacility
The sum of the personnel, test sites and test facilities necessary to carry out the test items. For a test item conducted at a test site, the test site includes the test site where the project sponsor is located and all other test sites, which can be used as test sites individually or as a whole.
Testfacilitymanagement Personnel with management authority over the organization and functions of the test site. 2.7
Testsitemanagerfesisite Management In a trial, the person who is responsible for the trial site and can ensure that this stage of the trial is carried out in accordance with good laboratory practices: 2.8
5 Sponsor
The person who entrusts, funds and authorizes the trial project. 2.9
The person who is responsible for the implementation and management of the trial project. 2.10
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Principal investigator refers to the researcher who, in a trial site trial, represents the person responsible for the trial project and is responsible for a commissioned trial stage in the trial. 2.11
Quality assurance
refers to the system of independent trial projects, including organizational system and personnel, designed to ensure that the trial institution follows good laboratory practices. 2. 12
Standard operating procedures ... 2.17
Study Plan AmendmentStudy Plan Amendment is any planned change to the study plan after the start of the study project. 2.18
Study Plan Deviation is any change to the study plan after the start of the study project that is not caused by subjective intention. 2.19
Study System is any system of biological (generally including the test organisms and their specific living conditions), chemical, physical or other materials used in the experiment.
Specimens
Study materials derived from the test system for aging, analysis and preservation. 2.21
Raw Data is the original record and documentary material that records the research work in the experiment, or a verified copy. For example: observation records, test notebooks, photographs, negatives, chromatograms, microfilm, magnetic carriers, computer prints, automated instrument records, etc. 2.22
Test start timeexperimental start datetime for collecting test data for the first time.
Experimental completion datedate for collecting test data for the last time. 2.24
Study initiation datestudy completion datedates when the person in charge of the test item signs the test plan. 2.25
Study completion datestudy completion datedates when the person in charge of the test item signs the final report. 2. 26
Test item
Substance to be tested in the test item:
Reference item
Substance to be compared with the test item in the test. 2.28
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Batch Fateh
The maximum number of test substances or reference substances produced in a certain period of time, they can be regarded as having an effective trait, 3 Organization and Personnel
3.1 Test Agency
The test agency for pesticide registration environmental evaluation should be a relatively independent full-time agency, with an institutional legal person certificate or a certificate of authorization by a legal person unit, and be able to independently, objectively and impartially carry out test activities: and bear the corresponding legal responsibilities. 3.2 Responsibilities of the test agency manager
The test agency manager should ensure that his agency complies with this specification. The other responsibilities of the test agency manager should at least include: 3.2.1 Ensure that there is: a statement that the certification agency complies with the requirements of good laboratory practice to perform the responsibilities of the manager. 3.2.2 Ensure that the number and quality of personnel are suitable for the work they undertake, and be equipped with corresponding test facilities, instruments and test materials to ensure that the test projects are carried out in a timely and normal manner. 3.2.3 Ensure that the subordinates are capable of performing their technical duties, and must be educated and trained, and have corresponding technical knowledge and work experience.
3.2.4 Ensure that the technical personnel files are established and preserved. This file includes qualification certificates, academic certificates, training records, technical performance, work experience and job responsibilities.
3.2.5 Ensure that appropriate and feasible standard operating procedures are formulated and approved and implemented. 3.2.6 Ensure that the quality assurance department is equipped with full-time personnel, appoint relevant personnel, and ensure that they perform their duties in accordance with good laboratory practices. 3.2.7 Before each test project is launched, a person with appropriate qualifications, training and experience should be appointed as the person in charge of the test project. The test institution manager should formulate a policy document to specify the selection, appointment and replacement procedures of the test project leader. The replacement of the test project leader during the test should be supported by supporting documents. 3.2.8 In multi-site tests, according to Lei An, ensure that the principal investigator has appropriate qualifications, training and experience. During the test, the additional investigators need to have corresponding procedures and supporting documents. 3.2.9 Ensure that the test project person in charge approves the test plan in writing. 3.2.10 Ensure that the quality assurance personnel obtain the test plan approved by the test item leader. 3.2.11 Ensure the preservation of all standard operating procedures. 3.2.12 Ensure that a dedicated person is responsible for the management of the test materials in the archives. 3.2.13 Ensure the preservation and management of the master schedule. 3.2.14 Ensure that the supply of the test agency meets the corresponding test requirements. 3.2.15 Ensure that the information exchange between the test item leader, key researchers, quality assurance personnel and test personnel in multi-site tests is smooth.
3.2.16 Ensure that the test and reference materials are clearly labeled according to their properties. 3.2.17 Ensure that the establishment of relevant procedures ensures that the computer data processing system meets the needs of the predetermined objectives and can ensure compliance with good laboratory practice for system verification, operation and maintenance. 3.2.18 In the case of multi-site testing, the test site manager shall be responsible for all the responsibilities listed in 3.2 above except 3.2.7, 3.2.9, 3.2.10 and 3.2.15 for the entrusted test stage. 3.3 Responsibilities of the Test Project Manager
The test project manager is the core of the test project management and is fully responsible for the implementation of the test, the entire process of the test and the final test report to ensure that the test complies with good laboratory practices. The responsibilities of the test project manager should at least include: 3.3.1 Before the test project is officially started, the test project manager should ensure that the test plan is reviewed by the quality assurance personnel to confirm whether it includes all the information required by good laboratory practices, ensure that it meets the technical requirements of the client, and confirm that the test organization manager has promised to have sufficient resources to carry out the test: the test materials, reference materials, etc. can meet the test requirements. 3.3.2 Approve the test plan and the test plan revision, sign and indicate the deadline. 3.3.3 Ensure that copies of the study plan and amendments are submitted to the quality assurance personnel in a timely manner and that effective communication with the quality assurance personnel is maintained as required during the study.
3.3.4 Ensure that the study plan and amendments are available to the study personnel at all times. 3.3.5 Ensure that the study plan and final report for multi-site studies clearly and clearly state the roles and responsibilities of the principal investigators, the study organization, and the study sites involved in the study. 3.3.6 Ensure that the study is carried out in accordance with the standard operating procedures specified in the study plan. 3.3.7 Ensure that deviations from the study plan are promptly known and any problems that arise are recorded. The impact of deviations from the study plan on the quality and integrity of the study should be evaluated and recorded, and appropriate corrective measures should be taken as necessary: Note deviations from standard operating procedures during the study:
3.3.8 Ensure that all original data generated by the study are fully recorded. 3.3.9 Ensure that a validated computer processing system is used in the test. 3.3.10 Sign the final report, commit that the test report fully, truthfully and accurately reflects the test process and test results, indicate the date of signature, and explain the degree of compliance with good laboratory practices. Attach a quality assurance statement, and explain any deviation from the test plan. 3.3.11 Ensure that after the test is completed (including the termination of the test), the test plan, final report, original data and related materials are filed in time. The final test report should state the storage location of all test substances, test products, original data, test plan, final report and other related documents and materials.
3.3.12 If the test is commissioned, the person in charge of the test project (and the quality assurance person) must understand the compliance of the test organization with good laboratory practices. If a contract organization does not comply with good laboratory practices, the project leader must state in the final report: 3.4 Responsibilities of the principal investigator
3.4.1 Responsible for a certain stage of the project entrusted by the project leader, responsible for the compliance of the project's experimental work with good laboratory practices, and the principal investigator should establish good communication and exchange channels with the project leader. 3.4.2 Should sign a written agreement, committing to implement the part of the experiment undertaken in accordance with the experimental plan and the requirements of this specification. 3.4.3 Should promptly understand the deviation from the experimental plan or standard operating procedures during the experiment, and report it to the project leader in a timely manner. 4
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3.4.4 Submit a sub-report for the preparation of the final report to the project leader. In the sub-report, there must be a written guarantee that the part of the experiment undertaken complies with good laboratory practices.
3.4.5 Ensure that all the data and test samples of the part of the experiment undertaken by the project leader are submitted or archived to the project leader according to the requirements of the experimental plan; if archived, the project leader should be informed of the archiving place and archiving time of the data and test samples. During the experiment, if there is no consent from the project leader, the principal investigator has no right to dispose of any test samples. 3.5 Responsibilities of the experimental personnel
3.5.1 Understand the requirements of good laboratory practice related to the part of the experiment undertaken by the principal investigator; 3.5.2 Understand the content of the experimental plan and the relevant standard operating procedures of the experiment undertaken by the principal investigator, and conduct the experiment in accordance with their requirements; 3.5.3 Record the original data in a timely and accurate manner and be responsible for its quality; 3.5.4 Any deviation in the experiment should be recorded in writing and reported directly to the principal investigator or the project leader. 3.5.5 Health protection measures should be implemented to reduce the harm to the body to ensure the integrity of the experiment. 4 Quality Assurance
4.1 Overview
4.1.1 The test organization shall have documents describing quality assurance to ensure that the tests undertaken comply with this specification. 4.1.2 The test organization manager shall appoint one or more personnel who are familiar with the test procedures and this specification to carry out quality assurance work (hereinafter referred to as quality assurance personnel). The quality assurance personnel shall be directly responsible to the test organization manager. 4:1.3 Quality assurance personnel shall not participate in the tests for which they are responsible for quality assurance. 4.2 Qualifications of Quality Assurance Personnel
4.2.1 They shall have sufficient professional background and qualifications, as well as necessary training experience. The training of quality assurers and the evaluation of their work ability shall be recorded. The training records shall be updated and archived at any time. 4.2.2 They shall understand the basic content of the test items to be inspected and have a deep understanding of this specification. 4.3 Responsibilities of Quality Assurance Personnel
The responsibilities of quality assurance personnel shall at least include: 4.3.1 Review standard operating procedures and determine whether they meet the requirements of this specification. 4.3.2 Hold copies of approved test plans and standard operating procedures in use, and obtain the latest version in a timely manner. 4.3.3 Review whether the test plan contains the content required by good laboratory practice, and document the verification results in writing. 4.3.4 Check whether all test items are implemented in accordance with this specification, and check whether the test personnel can easily obtain, are familiar with and comply with the test plan and specified standard operating procedures. The inspection records should be kept. There are three types of inspection methods specified in the standard operating procedures for quality assurance: 1. Inspection of test items: Inspection of the confirmed test chain for a given or test project process: Inspection of the test organization: Inspection of the test facility and daily activities (technical support, computer system, training, environmental monitoring, instrument maintenance and verification, etc.) instead of specific test items. Inspection of the operation process: Inspection of the process and steps carried out in the laboratory instead of specific test items. When the repetition frequency of a certain process in the laboratory is very high, the operation process can be checked. For the standardized short-term tests that are often carried out, it is not necessary to check each test item. The process inspection may cover all test items. According to the number, frequency and complexity of such tests, the inspection frequency should be specified in the quality assurance standard operation procedures, and it should be stated that such inspection is routine. 4.3.5 Check the final report and provide relevant quality assurance statements. The quality assurance personnel should confirm whether the final report records the test methods, test steps and observation results in detail and correctly, whether the test results can be correct, and whether the original data of the test can be fully reflected. Any additions and modifications to the content of the final report must be reviewed by the quality assurance personnel. 5
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4.3.6 Report the inspection results to the test agency manager, the person in charge of the test item, the principal investigator and various relevant managers (if applicable) in written form and time.
4.3.7 Quality Assurance Statement
4.3.7.1 The final report should include a quality assurance statement describing the manner in which the trial was reviewed, the dates and stages of the review, and the time at which the review results were reported to the trial site manager, trial project sponsor, and principal investigator. If the review of the trial project was not conducted according to the quality assurance review plan, the statement should detail other types of review conducted.
4.3.7.2 Before signing the quality assurance statement, the quality assurance personnel shall confirm that all issues raised during the review have been reflected in the final report, that all corrective actions taken have been completed, and that the final report does not need to be modified for further review. 4.4 Quality Assurance and Non-GLP Tests Some testing organizations may conduct two types of tests in the same test site area, namely tests for the purpose of submitting reports to regulatory agencies and other tests that do not have this purpose: the latter are not carried out in accordance with good laboratory practice and have a negative impact on the GLP test.
The quality assurance personnel should keep a master plan of GLP and non-GLP test items: objectively assess the workload, applicable facilities and possible interference. Once a non-GLP test has been started, it shall not be changed to a GLP test item. If the original test item is changed to a non-GLP test during the test, detailed instructions shall be provided.
4.5 Quality Assurance and Multi-site Testing
In multi-site testing, quality assurance work should be carefully planned and organized to ensure that the entire testing process follows good laboratory practice.
In multi-site testing, the responsibilities of quality assurance personnel are as follows: 4.5.1 The quality assurance personnel of the testing organization should maintain contact with the quality assurance personnel of each site to ensure that the quality assurance inspection covers the entire testing process. Before the start of the test at each site, the job responsibilities of the quality assurance personnel should be confirmed first. 4.5.2 The quality assurance personnel of each testing site should understand the responsibilities of the relevant experimental parts undertaken in the test plan, and should keep a copy of the approved test plan and modifications: 4.5.3 The quality assurance personnel of the test site should check the test parts undertaken in the plan according to the site standard operating procedures, and report the inspection results to the principal investigator, site management, project leader, test agency manager and institutional quality assurance department in writing in a timely manner, and submit a written statement on the quality assurance work of the site: 4.5.4 The quality assurance person in charge should check the compliance of the final report with good laboratory practices based on the test plan. The inspection content includes whether the test results of the key researchers and the site quality assurance statement are accepted. 4.6 Quality Assurance of Small Test Institutions
For small test institutions that have difficulty in arranging full-time quality assurance personnel: the test institution manager should arrange at least one fixed person to be responsible for quality assurance work, even if they are part-time, and the premise of part-time work is that the person does not participate in the test for which the quality assurance personnel are responsible. The stability of quality assurance personnel is necessary for the recognition of experience and the consistency of inspection results. 5 Test facilities
5.1 The pesticide environmental evaluation laboratory should be equipped with sufficient and large industrial land and other outdoor test sites that meet the test conditions. It should be familiar with the conditions of the test area over the years and have supporting documents to avoid the pollution of the test site by the neighboring areas and minimize the interference factors of the test
5.2 The test institution should have sufficient laboratory area. According to the test requirements, the corresponding test facilities should be built. Various test facilities should be kept clean and sanitary and operate normally to prevent cross contamination. It should be equipped with corresponding environmental control facilities, and the environmental conditions and their control components should meet the test requirements. The layout of instruments, equipment, electrical lines and pipelines should be appropriate. NY/T1906—2010
5.3 The configuration of various facilities related to the test system should be appropriate and complete to ensure that the preparation, application and processing of the test system meet the test quality requirements.
5.4 When the test method, standard operating procedures and procedures require strict control of environmental conditions, or when environmental conditions may affect the test results, the test environmental conditions should be monitored, controlled and recorded to ensure that dust, smoke, noise, vibration, magnetic interference, humidity, power supply and temperature inside and outside the test facility do not affect the test results. 5.5 The entry and exit and use of the area that affects the test quality should be controlled. 5.6 Protective facilities should be equipped to protect personal health and safety. 5.7 The test organization should ensure that there is enough space to store test samples. The reception and storage of test samples and reference materials, and the preparation of test samples should all be set up in separate rooms or areas to ensure that they are not contaminated or mixed. 5.8 The storage room or area for evidence should be separated from the room or area where the test samples are placed. Establish appropriate protection measures to ensure that their properties, content and stability do not change. 5.9 A complete archive room should be equipped. Test plans, original records, test reports, technical personnel resumes, instrument and equipment related records and other materials should be kept safely: the design and environmental control of the archive room should meet the requirements for long-term preservation of materials. 5.10 Dispose of waste without affecting the integrity of the test items. This treatment procedure should comply with the relevant regulations on waste collection, storage and treatment procedures:
6 Test system
6.1 Physical/chemical test system
6.1.1 Instruments for measuring physical and chemical indicators should be well placed, reasonably designed and have sufficient capacity. 6.1.2 The integrity of the chemical test system should be ensured. 6.2: Biological test system
6.2.1 Good environmental conditions should be established and maintained, and the quality of feed and water should be determined to ensure that the preservation, management, handling and feeding of the biological test system meet the requirements of the test quality. 6.2.2 Newly received animal test systems should be isolated before the health status evaluation is completed. If any abnormal death or illness occurs, they cannot be used for the test: they should be euthanized. At the beginning of the test, the test system should be ensured to be in good condition to avoid diseases or adverse environmental conditions affecting the purpose and implementation of the test. During the test, the test subject observes the phenomenon of illness or injury. If it is necessary to ensure the integrity of the test, it should be isolated and treated in time. The diagnosis and treatment of all diseases before and during the test should be recorded. The use of veterinary drugs should also be recorded. And there should be corresponding management procedures. 6.2.3 Records of the source of the test system, the date of receipt and the condition at the time of receipt should be kept. 6.2.4 Before the first administration of the test substance or the use of the test substance or reference substance, a corresponding test environment adaptation period should be set for the biological test system. 6.2.5 All information that can clearly identify the test system should be clearly marked on the corresponding cage or container: individual test systems taken out of the cage or container during the test should also be properly marked. 6.2.6 The containers for feeding and handling the test system should be cleaned and disinfected regularly. Any material in contact with the test system should not contain pollutants or their levels should not be high enough to interfere with the test results. Animal bedding should be changed regularly according to the requirements of the management specifications, and records of the application of worms should be kept.
6.2.7 The test system area for field trials should be selected to avoid the influence of pesticide spray drift and the influence of pesticides applied previously. 6.2.8 The selection of soil microbial test systems should use the corresponding detection methods to ensure that the soil properties or microbial quantity and its activity meet the requirements of the test system.
6.2.9 For the selection of dissipation test systems, the air condition is the primary consideration. The test site with typical climate characteristics of the field application area should be selected for the test.
6.2.10 The establishment of the microcosm test system of the water ecosystem should ensure that the density of all living organisms and water quality parameters in the system meet the test safety requirements within the specified cultivation time NY/T 1906-201C
. The terrestrial ecosystem microcosm test system should be built in a greenhouse and strictly control the light and temperature. The selection of the test system should be representative of the field application, and the number and activity of microorganisms in the selected soil, the distribution and abundance of invertebrates, the growth status, growth environment and germination rate of seeds should be accurately determined. 7 Instruments and test materials
7.1 Instruments and equipment
7.1.1 The instruments and equipment required for each test and test environment should be equipped, such as computer data processing systems for data generation, storage and retrieval, test environment condition control equipment, etc., and they should be properly placed in time. 7.1.2 The instruments and equipment should be maintained in accordance with the prescribed procedures. 7.1.3 The system shall have procedures for the use, maintenance, calibration, management and verification of instruments and equipment, and measures to be taken when abnormal conditions occur. 7.1.4 A specific person shall be designated to be responsible for the instruments and equipment. 7.1.5 The inspection, maintenance, use and verification of instruments and equipment shall be accompanied by supporting documents. When instruments and equipment fail, maintenance records shall be kept to clearly state the type of failure, cause, treatment measures and results. 7.1.6 The equipment should have obvious markings indicating its verification status. 7.1.7 The equipment files should be kept, including the name and model of the equipment;
—— Laboratory unique number:
"Manufacturer name;
Instrument receipt date, status and activation date: Instructions for use:
—— Instrument installation, commissioning and acceptance records; —— Verification/calibration date and results (certificate), and the date of the next verification/calibration; Failure, damage, repair and scrapping records; —— Usage records.
7.1.8 The equipment and test materials used for the test should not have adverse effects on the test samples. 7.2 Test Materials
7.2.1 Chemical reagents should be marked with name, grade, batch number, quantity, validity period and storage conditions. The validity period can be extended based on relevant written materials or analysis results. bzxZ.net
7.2.2 Chemical solutions should have preparation procedures and records: the label should indicate the name, concentration, preparer, preparation date, validity period and storage conditions of the solution. Deteriorated or expired reagents or solutions should not be used. 7.2.3 Test substances and reference materials should be kept by a dedicated person, with complete receipt, registration and distribution procedures, and the name of the client, the name of the person in charge of both parties, the complete name, status description, pesticide category, hazard level, receipt date, validity period, receipt quantity, packaging, precautions and test usage records of the test substances and reference materials should be recorded.
7.2.4 Storage containers for test substances and reference materials should be labeled with the name, code, batch number, quantity, validity period and storage conditions. 7.2.5 Procedures for handling, sampling and storage of test materials such as test substances and test samples should be established to ensure their homogeneity and stability as much as possible and to exclude transfection or confusion with other substances.
7.2.6 When distributing and receiving test substances, reference substances and test samples, the names and batch numbers should be checked: the expiration date should be indicated, and the person in charge should sign after both parties agree
7.2.7 Test personnel should understand the stability of test substances, reference substances and test samples under storage and test conditions. 7.2.8 Except for short-term tests, samples for analysis should be retained for each batch of test substances in all tests. 8
8 Standard operating procedures
8.1 Standard operating procedures should be formulated to ensure the standardization of the test process and the accuracy and completeness of the test data. 8.2 The preparation and revision procedures of standard operating procedures should be formulated. 8.3 Standard operating procedures should at least include the following: laboratory environment control; use, maintenance, calibration and verification of instruments and equipment; confirmation, use, maintenance, change management and backup of computer systems; use of indexing systems and computer systems; procurement, acceptance, use, storage and management of consumables; receipt, identification, labeling, storage and handling of test and reference materials; preparation, storage and handling of laboratory samples; preparation, calibration, verification, labeling and testing of standard solutions; verification and establishment of test methods; preparation, observation, specimen collection, determination, inspection, analysis and testing of test systems. 1. Processing of the test results; collection and processing of raw data; disposal of waste materials; preparation, review and approval of the final report; preparation of the test plan; training, assessment, appointment and health check of personnel: NY/T1906—2010. Quality assurance procedures: the work procedures for planning, arranging, implementing, recording and reporting of quality assurance personnel; archival management of technical documents such as personnel resumes, instrument and equipment documents, original records, and complete reports. 8.4 The standard operating procedures shall be terminated after being signed and reviewed by the quality assurance personnel and approved in writing by the test agency manager. The standard operating procedures for fire efficiency shall be destroyed in a timely manner except for one copy for archiving. 8.5 The preparation, revision, effective date, distribution and destruction of standard operating procedures shall be recorded and filed. 8.6 The standard operating procedures shall be effective and convenient for use. 8.7 Any operation that deviates from the standard operating procedures during the test shall be approved by the project manager and recorded. The revision of the standard operating procedures shall be effective after confirmation by the quality assurance department and written approval by the test organization manager. Publicly published textbooks, methods, papers and manuals can be used as supplementary materials for standard operating procedures: 8.8 All versions of standard operating procedures should be kept. 9 Test plan and test implementation
9.1 Test plan
9.1.1 Before each test project is started, the department should have a written test plan. The test plan should be reviewed by the quality assurance personnel in accordance with the requirements of this specification, signed and approved by the person in charge of the test project, and the deadline should be indicated. If necessary, the test plan should also be approved by the test organization manager and the client.
9.1.2 Any changes to the test plan [5] should be reviewed by the quality assurance personnel and approved by the person in charge of the test project, and approved by the client when necessary. The contents, reason and date of the changes shall be the same as those in the original study plan. 9.13 The person in charge of the study project or the principal investigator shall promptly explain, justify and notify any deviations from the study plan, sign and indicate the date, and archive them together with the original data. 9.1.4 Each multi-site study shall have only one study plan, which shall clearly state the procedures for providing the study data generated at multiple sites to the person in charge of the study project, and the locations where the study data, test and reference materials and test samples generated at different sites are stored. For studies conducted in multiple countries, the study plan shall have more than one translation when necessary, and the translated study plan shall be consistent with the original version. 9.2 Contents of the Test Plan The test plan shall at least include the following contents: - Name of the test project, test number and test date; - Name, code, batch number and physical and chemical properties of the test substance and reference substance; - Name and address of the client, the person in charge and the test institution, and the test sites involved; - Name and address of the person in charge of the test project, the name and address of the principal investigator, the test phase and responsibilities of the principal investigator designated by the person in charge; - Approval of the test plan by the test project sponsor, the test institution manager (if necessary), and the client (if necessary). Signature and date; —— Test method to be adopted. According to the purpose of the test, reference may be made to national standards, industry standards, and other recognized international organizations' test criteria and methods, etc.: —— Expected start and completion dates of the test: —— Reasons for the selection of the test system; —— Characteristics of the test system; —— Detailed information on the test design, including a time schedule for the test method, description of material conditions, types and times of measurements, observations, inspections, and analyses to be performed, and the statistical methods to be adopted; Records to be kept, and recommended locations for the archiving of data and specimens. 9.3 Test implementation 9.3.1 Each test item should be assigned a unique number, and all test samples, records, and documents involved in the test should be marked with this number. The test samples and test process can be traced back through the number. 9.3.2 The project leader shall be fully responsible for the operation and management of the project. Participants in the experiment should strictly follow the test plan and standard operating procedures. If any abnormal or unexpected phenomenon occurs during the test, it should be reported to the main researcher or project leader in time and recorded in detail. If there is any personnel change during the test, it should be replaced according to the program. 9.3.3 The test record should be in a fixed format and the test item name or code should be used uniformly. All data should be recorded in a timely and direct manner, with accurate, clear and not easily erased date and signature. When the recorded data needs to be modified: the original record should be kept clear and legible, and the revision and modification date should be indicated, and the modified signature should be signed.
9.3.4 The data directly input into the computer should be confirmed and approved by the data inputter at the time of input: the computer system should be able to retain all verification records to show the traces of all modified data without overwriting the original data. The person who modifies the data should have his or her regular and periodic (electronic) signature on all modified data. The reason for the change should be entered when the data is revised. 10 Test Report
10.1 Overview
10.1.1 Each test item should have a final test report. 10.1.2 The report completed by the principal investigator of the test item should be signed by him/her and the date should be indicated. 10.1.3 The person in charge of the test item should sign the final report and indicate the date, declaring that he/she is responsible for the validity of the data. At the same time, the degree (or situation) of compliance with the laboratory regulations should be stated. 10.1.4 Corrections or supplements to the final report should be made in the form of report revisions: the revisions should clearly state the reasons for the corrections or supplements, and finally should be signed by the person in charge of the test item and the date should be indicated. 10.1.5 If the final report needs to be registered according to the client and needs to be rearranged in format, it should not constitute a correction or supplement to the final report.
10.2 The basic contents that the final report should at least include 194 Storage containers for test substances and reference materials must be labeled with the name, code, batch number, quantity, validity period and storage conditions. 7.2.5 Procedures for handling, sampling and storage of test materials such as test substances and test samples should be established to ensure their homogeneity and stability as much as possible and exclude transfection or confusion with other substances.
7.2.6 When test substances, reference substances and test samples are distributed and received, the names and batch numbers should be checked, the expiration date should be indicated, and the person in charge should sign after both parties agree
7.2.7 Test personnel should understand the stability of test substances, reference substances and test samples under storage and test conditions. 7.2.8 Except for short-term tests, samples for analysis should be retained for each batch of test substances in all tests. 8
8 Standard operating procedures
8.1 Standard operating procedures should be formulated to ensure the standardization of the test process and the accuracy and completeness of the test data. 8.2 The preparation and revision procedures of standard operating procedures should be formulated. 8.3 Standard operating procedures should at least include the following: laboratory environment control; use, maintenance, calibration and verification of instruments and equipment; confirmation, use, maintenance, change management and backup of computer systems; use of indexing systems and computer systems; procurement, acceptance, use, storage and management of consumables; receipt, identification, labeling, storage and handling of test and reference materials; preparation, storage and handling of laboratory samples; preparation, calibration, verification, labeling and testing of standard solutions; verification and establishment of test methods; preparation, observation, specimen collection, determination, inspection, analysis and testing of test systems. 1. Processing of the test results; collection and processing of raw data; disposal of waste materials; preparation, review and approval of the final report; preparation of the test plan; training, assessment, appointment and health check of personnel: NY/T1906—2010. Quality assurance procedures: the work procedures for planning, arranging, implementing, recording and reporting of quality assurance personnel; archival management of technical documents such as personnel resumes, instrument and equipment documents, original records, and complete reports. 8.4 The standard operating procedures shall be terminated after being signed and reviewed by the quality assurance personnel and approved in writing by the test agency manager. The standard operating procedures for fire efficiency shall be destroyed in a timely manner except for one copy for archiving. 8.5 The preparation, revision, effective date, distribution and destruction of standard operating procedures shall be recorded and filed. 8.6 The standard operating procedures shall be effective and convenient for use. 8.7 Any operation that deviates from the standard operating procedures during the test shall be approved by the project manager and recorded. The revision of the standard operating procedures shall be effective after confirmation by the quality assurance department and written approval by the test organization manager. Publicly published textbooks, methods, papers and manuals can be used as supplementary materials for standard operating procedures: 8.8 All versions of standard operating procedures should be kept. 9 Test plan and test implementation
9.1 Test plan
9.1.1 Before each test project is started, the department should have a written test plan. The test plan should be reviewed by the quality assurance personnel in accordance with the requirements of this specification, signed and approved by the person in charge of the test project, and the deadline should be indicated. If necessary, the test plan should also be approved by the test organization manager and the client.
9.1.2 Any changes to the test plan [5] should be reviewed by the quality assurance personnel and approved by the person in charge of the test project, and approved by the client when necessary. The contents, reason and date of the changes shall be the same as those in the original study plan. 9.13 The person in charge of the study project or the principal investigator shall promptly explain, justify and notify any deviations from the study plan, sign and indicate the date, and archive them together with the original data. 9.1.4 Each multi-site study shall have only one study plan, which shall clearly state the procedures for providing the study data generated at multiple sites to the person in charge of the study project, and the locations where the study data, test and reference materials and test samples generated at different sites are stored. For studies conducted in multiple countries, the study plan shall have more than one translation when necessary, and the translated study plan shall be consistent with the original version. 9.2 Contents of the Test Plan The test plan shall at least include the following contents: - Name of the test project, test number and test date; - Name, code, batch number and physical and chemical properties of the test substance and reference substance; - Name and address of the client, the person in charge and the test institution, and the test sites involved; - Name and address of the person in charge of the test project, the name and address of the principal investigator, the test phase and responsibilities of the principal investigator designated by the person in charge; - Approval of the test plan by the test project sponsor, the test institution manager (if necessary), and the client (if necessary). Signature and date; —— Test method to be adopted. According to the purpose of the test, reference may be made to national standards, industry standards, and other recognized international organizations' test criteria and methods, etc.: —— Expected start and completion dates of the test: —— Reasons for the selection of the test system; —— Characteristics of the test system; —— Detailed information on the test design, including a time schedule for the test method, description of material conditions, types and times of measurements, observations, inspections, and analyses to be performed, and the statistical methods to be adopted; Records to be kept, and recommended locations for the archiving of data and specimens. 9.3 Test implementation 9.3.1 Each test item should be assigned a unique number, and all test samples, records, and documents involved in the test should be marked with this number. The test samples and test process can be traced back through the number. 9.3.2 The project leader shall be fully responsible for the operation and management of the project. Participants in the experiment should strictly follow the test plan and standard operating procedures. If any abnormal or unexpected phenomenon occurs during the test, it should be reported to the main researcher or project leader in time and recorded in detail. If there is any personnel change during the test, it should be replaced according to the program. 9.3.3 The test record should be in a fixed format and the test item name or code should be used uniformly. All data should be recorded in a timely and direct manner, with accurate, clear and not easily erased date and signature. When the recorded data needs to be modified: the original record should be kept clear and legible, and the revision and modification date should be indicated, and the modified signature should be signed.
9.3.4 The data directly input into the computer should be confirmed and approved by the data inputter at the time of input: the computer system should be able to retain all verification records to show the traces of all modified data without overwriting the original data. The person who modifies the data should have his or her regular and periodic (electronic) signature on all modified data. The reason for the change should be entered when the data is revised. 10 Test Report
10.1 Overview
10.1.1 Each test item should have a final test report. 10.1.2 The report completed by the principal investigator of the test item should be signed by him/her and the date should be indicated. 10.1.3 The person in charge of the test item should sign the final report and indicate the date, declaring that he/she is responsible for the validity of the data. At the same time, the degree (or situation) of compliance with the laboratory regulations should be stated. 10.1.4 Corrections or supplements to the final report should be made in the form of report revisions: the revisions should clearly state the reasons for the corrections or supplements, and finally should be signed by the person in charge of the test item and the date should be indicated. 10.1.5 If the final report needs to be registered according to the client and needs to be rearranged in format, it should not constitute a correction or supplement to the final report.
10.2 The basic contents that the final report should at least include 194 Storage containers for test substances and reference materials must be labeled with the name, code, batch number, quantity, validity period and storage conditions. 7.2.5 Procedures for handling, sampling and storage of test materials such as test substances and test samples should be established to ensure their homogeneity and stability as much as possible and exclude transfection or confusion with other substances.
7.2.6 When test substances, reference substances and test samples are distributed and received, the names and batch numbers should be checked, the expiration date should be indicated, and the person in charge should sign after both parties agree
7.2.7 Test personnel should understand the stability of test substances, reference substances and test samples under storage and test conditions. 7.2.8 Except for short-term tests, samples for analysis should be retained for each batch of test substances in all tests. 8
8 Standard operating procedures
8.1 Standard operating procedures should be formulated to ensure the standardization of the test process and the accuracy and completeness of the test data. 8.2 The preparation and revision procedures of standard operating procedures should be formulated. 8.3 Standard operating procedures should at least include the following: laboratory environment control; use, maintenance, calibration and verification of instruments and equipment; confirmation, use, maintenance, change management and backup of computer systems; use of indexing systems and computer systems; procurement, acceptance, use, storage and management of consumables; receipt, identification, labeling, storage and handling of test and reference materials; preparation, storage and handling of laboratory samples; preparation, calibration, verification, labeling and testing of standard solutions; verification and establishment of test methods; preparation, observation, specimen collection, determination, inspection, analysis and testing of test systems. 1. Processing of the test results; collection and processing of raw data; disposal of waste materials; preparation, review and approval of the final report; preparation of the test plan; training, assessment, appointment and health check of personnel: NY/T1906—2010. Quality assurance procedures: the work procedures for planning, arranging, implementing, recording and reporting of quality assurance personnel; archival management of technical documents such as personnel resumes, instrument and equipment documents, original records, and complete reports. 8.4 The standard operating procedures shall be terminated after being signed and reviewed by the quality assurance personnel and approved in writing by the test agency manager. The standard operating procedures for fire efficiency shall be destroyed in a timely manner except for one copy for archiving. 8.5 The preparation, revision, effective date, distribution and destruction of standard operating procedures shall be recorded and filed. 8.6 The standard operating procedures shall be effective and convenient for use. 8.7 Any operation that deviates from the standard operating procedures during the test shall be approved by the project manager and recorded. The revision of the standard operating procedures shall be effective after confirmation by the quality assurance department and written approval by the test organization manager. Publicly published textbooks, methods, papers and manuals can be used as supplementary materials for standard operating procedures: 8.8 All versions of standard operating procedures should be kept. 9 Test plan and test implementation
9.1 Test plan
9.1.1 Before each test project is started, the department should have a written test plan. The test plan should be reviewed by the quality assurance personnel in accordance with the requirements of this specification, signed and approved by the person in charge of the test project, and the deadline should be indicated. If necessary, the test plan should also be approved by the test organization manager and the client.
9.1.2 Any changes to the test plan [5] should be reviewed by the quality assurance personnel and approved by the person in charge of the test project, and approved by the client when necessary. The contents, reason and date of the changes shall be the same as those in the original study plan. 9.13 The person in charge of the study project or the principal investigator shall promptly explain, justify and notify any deviations from the study plan, sign and indicate the date, and archive them together with the original data. 9.1.4 Each multi-site study shall have only one study plan, which shall clearly state the procedures for providing the study data generated at multiple sites to the person in charge of the study project, and the locations where the study data, test and reference materials and test samples generated at different sites are stored. For studies conducted in multiple countries, the study plan shall have more than one translation when necessary, and the translated study plan shall be consistent with the original version. 9.2 Contents of the Test Plan The test plan shall at least include the following contents: - Name of the test project, test number and test date; - Name, code, batch number and physical and chemical properties of the test substance and reference substance; - Name and address of the client, the person in charge and the test institution, and the test sites involved; - Name and address of the person in charge of the test project, the name and address of the principal investigator, the test phase and responsibilities of the principal investigator designated by the person in charge; - Approval of the test plan by the test project sponsor, the test institution manager (if necessary), and the client (if necessary). Signature and date; —— Test method to be adopted. According to the purpose of the test, reference may be made to national standards, industry standards, and other recognized international organizations' test criteria and methods, etc.: —— Expected start and completion dates of the test: —— Reasons for the selection of the test system; —— Characteristics of the test system; —— Detailed information on the test design, including a time schedule for the test method, description of material conditions, types and times of measurements, observations, inspections, and analyses to be performed, and the statistical methods to be adopted; Records to be kept, and recommended locations for the archiving of data and specimens. 9.3 Test implementation 9.3.1 Each test item should be assigned a unique number, and all test samples, records, and documents involved in the test should be marked with this number. The test samples and test process can be traced back through the number. 9.3.2 The project leader shall be fully responsible for the operation and management of the project. Participants in the experiment should strictly follow the test plan and standard operating procedures. If any abnormal or unexpected phenomenon occurs during the test, it should be reported to the main researcher or project leader in time and recorded in detail. If there is any personnel change during the test, it should be replaced according to the program. 9.3.3 The test record should be in a fixed format and the test item name or code should be used uniformly. All data should be recorded in a timely and direct manner, with accurate, clear and not easily erased date and signature. When the recorded data needs to be modified: the original record should be kept clear and legible, and the revision and modification date should be indicated, and the modified signature should be signed.
9.3.4 The data directly input into the computer should be confirmed and approved by the data inputter at the time of input: the computer system should be able to retain all verification records to show the traces of all modified data without overwriting the original data. The person who modifies the data should have his or her regular and periodic (electronic) signature on all modified data. The reason for the change should be entered when the data is revised. 10 Test Report
10.1 Overview
10.1.1 Each test item should have a final test report. 10.1.2 The report completed by the principal investigator of the test item should be signed by him/her and the date should be indicated. 10.1.3 The person in charge of the test item should sign the final report and indicate the date, declaring that he/she is responsible for the validity of the data. At the same time, the degree (or situation) of compliance with the laboratory regulations should be stated. 10.1.4 Corrections or supplements to the final report should be made in the form of report revisions: the revisions should clearly state the reasons for the corrections or supplements, and finally should be signed by the person in charge of the test item and the date should be indicated. 10.1.5 If the final report needs to be registered according to the client and needs to be rearranged in format, it should not constitute a correction or supplement to the final report.
10.2 The basic contents that the final report should at least include 193 Standard operating procedures should at least include the following: laboratory environment control; use, maintenance, calibration and verification of instruments and equipment; confirmation, use, maintenance, change management and backup of computer systems; use of indexing systems and computer systems; procurement, acceptance, use, storage and management of consumables; receipt, identification, labeling, storage and handling of test and reference materials; preparation, storage and management of laboratory samples; calibration, verification, labeling and investigation management of standard solutions; validation and establishment of test methods; preparation, observation, specimen collection, determination, inspection, analysis and post-test of test systems. 1. Processing of raw data; collection and processing of original data; disposal of waste materials; preparation, review and approval of final report; preparation of test plan; training, assessment, appointment and health check of personnel: NY/T1906—2010; quality assurance procedures: the work procedures for planning, arranging, implementing, recording and reporting of quality assurance personnel; archival management of technical documents such as personnel resume, instrument and equipment documents, original records, and complete reports. 8.4 The standard operating procedures shall be terminated after being signed and reviewed by the quality assurance personnel and approved in writing by the test agency manager. The standard operating procedures for fire efficiency shall be destroyed in time except for one copy for archiving. 8.5 The preparation, revision, effective date, distribution and destruction of standard operating procedures shall be recorded and filed. 8.6 The standard operating procedures shall be effective and convenient for use. 8.7 Any operation that deviates from the standard operating procedures during the test shall be approved by the project manager and recorded. The revision of the standard operating procedures shall be effective after confirmation by the quality assurance department and written approval by the test organization manager. Publicly published textbooks, methods, papers and manuals can be used as supplementary materials for standard operating procedures: 8.8 All versions of standard operating procedures should be kept. 9 Test plan and test implementation
9.1 Test plan
9.1.1 Before each test project is started, the department should have a written test plan. The test plan should be reviewed by the quality assurance personnel in accordance with the requirements of this specification, signed and approved by the person in charge of the test project, and the deadline should be indicated. If necessary, the test plan should also be approved by the test organization manager and the client.
9.1.2 Any changes to the test plan [5] should be reviewed by the quality assurance personnel and approved by the person in charge of the test project, and approved by the client when necessary. The contents, reason and date of the changes shall be the same as those in the original study plan. 9.13 The person in charge of the study project or the principal investigator shall promptly explain, justify and notify any deviations from the study plan, sign and indicate the date, and archive them together with the original data. 9.1.4 Each multi-site study shall have only one study plan, which shall clearly state the procedures for providing the study data generated at multiple sites to the person in charge of the study project, and the locations where the study data, test and reference materials and test samples generated at different sites are stored. For studies conducted in multiple countries, the study plan shall have more than one translation when necessary, and the translated study plan shall be consistent with the original version. 9.2 Contents of the Test Plan The test plan shall at least include the following contents: - Name of the test project, test number and test date; - Name, code, batch number and physical and chemical properties of the test substance and reference substance; - Name and address of the client, the person in charge and the test institution, and the test sites involved; - Name and address of the person in charge of the test project, the name and address of the principal investigator, the test phase and responsibilities of the principal investigator designated by the person in charge; - Approval of the test plan by the test project sponsor, the test institution manager (if necessary), and the client (if necessary). Signature and date; —— Test method to be adopted. According to the purpose of the test, reference may be made to national standards, industry standards, and other recognized international organizations' test criteria and methods, etc.: —— Expected start and completion dates of the test: —— Reasons for the selection of the test system; —— Characteristics of the test system; —— Detailed information on the test design, including a time schedule for the test method, description of material conditions, types and times of measurements, observations, inspections, and analyses to be performed, and the statistical methods to be adopted; Records to be kept, and recommended locations for the archiving of data and specimens. 9.3 Test implementation 9.3.1 Each test item should be assigned a unique number, and all test samples, records, and documents involved in the test should be marked with this number. The test samples and test process can be traced back through the number. 9.3.2 The project leader shall be fully responsible for the operation and management of the project. Participants in the experiment should strictly follow the test plan and standard operating procedures. If any abnormal or unexpected phenomenon occurs during the test, it should be reported to the main researcher or project leader in time and recorded in detail. If there is any personnel change during the test, it should be replaced according to the program. 9.3.3 The test record should be in a fixed format and the test item name or code should be used uniformly. All data should be recorded in a timely and direct manner, with accurate, clear and not easily erased date and signature. When the recorded data needs to be modified: the original record should be kept clear and legible, and the revision and modification date should be indicated, and the modified signature should be signed.
9.3.4 The data directly input into the computer should be confirmed and approved by the data inputter at the time of input: the computer system should be able to retain all verification records to show the traces of all modified data without overwriting the original data. The person who modifies the data should have his or her regular and periodic (electronic) signature on all modified data. The reason for the change should be
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