In 2017, the Ministry of Agriculture and Rural Affairs issued and implemented the "Quality Management Standard for Pesticide Registration Test" (hereinafter referred to as the "Standard"). The "Code" is an important normative document for the identification of pesticide registration testing units, and is also a code of conduct for pesticide registration testing units to implement registration tests. In the process of formulation, the Code draws on the main content of the internationally recognized and authoritative Good Laboratory practice (GLP) of the Organization for Economic Cooperation and Development (OECD), and combines the actual situation of China and the accumulated experience of the implementation of pesticide registration test management for many years. The main purpose of promulgation of the "Standard" is to further strengthen the management of pesticide registration test, ensure the authenticity and reliability of pesticide registration test data, realize the traceability of pesticide registration test process, and ensure the scientific and accuracy of pesticide registration review.
The Specification puts forward 10 specific requirements for pesticide registration and testing units, mainly including organization and personnel, quality assurance, test facilities, instruments, materials and reagents, test system, subjects, controls and samples, standard operating procedures, test project implementation, test reports, archiving and preservation, etc. The test items of product chemistry, efficacy, toxicology, residue and environmental impact in pesticide registration test should be carried out in accordance with this requirement. In this paper, the 10 elements of the Code are interpreted in detail according to the technical review requirements of pesticide registration test units, so as to facilitate the understanding and mastery of pesticide registration test units, pesticide registration applicants and interested personnel.
1 Organization and personnel
Article 4 of the Code requires pesticide registration test units to establish a sound organization and management system, equipped with test unit leaders, test project leaders, quality assurance personnel, test personnel, archivists, sample managers, etc. The organization management system mainly includes four elements: organization, resources, procedures and processes. The perfect organization and management system of pesticide registration test unit should be a clear organization, complete personnel, facilities and instruments, perfect management system, good internal operation, supervision and management in place.
To apply for a pesticide registration test, a unit should first establish an organization that is compatible with the system, including at least the quality assurance department, the comprehensive coordination and support service business department and the department that is compatible with the test scope, and clarify the post functions of each department; It is equipped with management personnel and professional and technical personnel suitable for the registered test scope undertaken by it. In order to ensure that personnel can better perform their duties, it is necessary to establish various types of personnel management standard operating procedures (Sops), including personnel conditions, recruitment, training, authorization and appointment, assessment and evaluation. Such personnel include institutional heads, quality assurance personnel, test project leaders, archivists, sample managers, standard material managers, test personnel, instrument managers and other technical and managerial personnel. To establish a legal labor or employment relationship with employees, that is, to have a legal labor relationship certificate and sign a use agreement.
1.1 Responsibilities of main personnel of the test unit
The head of the experimental unit (FM) is the top manager of the experimental unit, generally the legal representative or the person authorized by the legal person. It is fully responsible for the construction and organization of the test unit, provides all kinds of human and material resources needed to meet the test, can ensure that the pesticide registration test undertaken by the unit fulfils the requirements of the Code, and takes overall responsibility for the operation of the organization. In the "Code" there are mainly 12 aspects of responsibility.
The pilot project leader (SD) is the person who has overall responsibility for the implementation and management of the pilot project undertaken. SD is the core of the implementation and management of the test project and is responsible for the test process and the final test report results. SD should be familiar with the professional technology in the field, be able to correctly understand and implement the test guidelines, timely detect and scientifically evaluate possible deviations in the test process, and should also have a more comprehensive and in-depth understanding of the relevant requirements of the Code and pesticide registration data. The number of SD configurations should match the test scope, test items and actual workload undertaken. SD is appointed, appointed or employed by FM. In the "pesticide registration test quality management standard", there are mainly 10 aspects of responsibility.
As the supervisor, the quality assurance personnel (QA) has the responsibility to supervise the operation of the test unit and the development of the test project. The most basic responsibility of QA is to ensure that the Specification is fully and effectively complied with in the test unit and during the test process, and to provide evidence for the effective operation of its system. QA is relatively independent when performing its duties. It should record truthfully and accurately the problems found in the supervision process, and communicate effectively with FM and SD in a timely manner to ensure the fairness and authenticity of quality assurance. In the "Code" there are eight main aspects of responsibility.
The Code also specifies the duties of test personnel, file management personnel and sample management personnel.
1.2 Job Requirements
The person in charge of the test unit, the person in charge of the test project, the quality assurance personnel, the file administrator and the sample administrator belong to the key positions, and there should be no crossover in the position setting of the organization personnel. The person in charge of the test project shall not cross the scope of pesticide registration test. The person in charge of a certain type of test item (such as insecticide) in the field of efficacy test cannot concurrently be the person in charge of another type of test item; In the field of environmental impact testing, the test project leader of ecotoxicology test and environmental regression test cannot be cross-appointed. All staff members shall not hold (concurrently) positions in 2 or more pesticide registration testing units identified by the Ministry of Agriculture and Rural Affairs. Non-pesticide registration test unit to the identification unit part-time, should be approved by the unit, and provide relevant certification materials.
The number and structure of the personnel of the test unit, education level, technical background and experience, practical operation ability, professional quality, etc., shall meet the test scope, the test project undertaken and the workload requirements. The leader of the test project should generally have a bachelor's degree or above in the relevant professional field, and have at least 3 years of experimental experience in the professional field. Quality assurance department personnel should generally have a bachelor's degree or above in the relevant professional field, and have at least 3 years of relevant test and quality assurance work experience. Test personnel should generally have a college degree or above in the relevant professional field, or have at least 2 years of test work experience. Relevant personnel engaged in research in related fields during the school education, master's and doctoral graduates are recognized as having 1 year and 1 year experimental work experience in this professional field. Senior technical personnel engaged in grass-roots work for a long time, the relevant educational requirements can be appropriately relaxed.
It should be emphasized that all personnel of the pesticide registration test unit must undergo the "Specification", relevant SOP and relevant professional skills training before they can perform their respective duties.
2 Quality Assurance
The Specification puts forward specific requirements for the quality assurance work of pesticide registration and testing units, which are mainly understood in the following five aspects: First, there should be an independent quality assurance department (QAU) and QA, and the number, qualification, experience and training of quality assurance person (QAM) and QA personnel should meet the job requirements; Second, the quality assurance personnel should have a certain professional technical background and quality assurance work experience, familiar with the "specifications" and test procedures as well as the management requirements of pesticide registration test units, with good communication skills and execution capabilities, appointed by FM directly, directly responsible for it; Third, do not participate in the test project being inspected; The fourth is to develop a quality assurance plan and carry out various inspection activities to ensure that the test projects undertaken comply with the "Specifications"; Fifth, if there is a multi-site test, the whole process of each test project and each site involved should also comply with the requirements of the Code.
2.1 QAU
QAU is the core of the implementation of the "Standard" quality management system, and its main functions are: first, to serve the test unit itself, support and cooperate with SD to complete the test task with high quality, and form a relationship of mutual cooperation and help; The second is to discover the problem in time, correct the problem as soon as possible, reduce the quality of the test report and the risk of not meeting the requirements, being returned by the pesticide registration review department, and be questioned, and ensure that the safety test evaluation data submitted to the pesticide registration management department is true, reliable, complete and traceable; The third is to safeguard the legitimate interests of the principal and reduce unnecessary disputes with the principal; The fourth is to avoid and reduce external audit problems.
2.2 QA
In order to ensure that every link and process of the test project meets the requirements of the Specification, QA needs to carry out a series of inspections and develop the inspection SOP. The inspection focus of QA is generally not technical aspects, but whether the test meets the requirements of the specification and whether the test plan and SOP are implemented as the inspection focus. Before carrying out the inspection, QA should formulate the inspection plan, mainly determine the inspection content and implementation time according to the test plan and the master plan table, and specify the specific QA. QA inspection is generally divided into three categories: test item inspection, process inspection, and facility inspection.
2.2.1 Test item inspection
Test item inspection shall cover each test item. It is generally not necessary to check every step of every project, but to select the key steps. Key steps Select the steps that are risky, important, influential, and representative of the entire test process. QA should ensure that at least 1 key step of each project is available for inspection on site.
2.2.2 Process Check
Process inspection is generally not for specific test items, mainly for repetitive or routine testing procedures or links for regular inspection, and this procedure or link can not be checked or effectively supervised through the test, such as standard sample management, solution labeling, instrument use records, waste disposal, etc. QA shall conduct process inspection, and shall also make inspection plan according to the specified inspection frequency, such as every 3 months or 6 months; In response to some recent problems in the laboratory, QA can also temporarily initiate targeted process inspections, such as interference from unknown sources in laboratory testing. While excluding factors such as instrument and personnel operation, QA can consider conducting an inspection of the laboratory utensil cleaning process to ensure that the laboratory personnel have followed the relevant SOP for the utensil cleaning. Process checks cannot be used as a substitute for test item checks.
2.2.3 Facilities Check
Facility inspection, also known as institutional inspection, is mainly aimed at the inspection of the overall facilities and functions of the test unit, and is a comprehensive and comprehensive evaluation of the compliance of the entire institutional test facilities with the Code. This inspection is not targeted at specific projects, but in accordance with the 10 elements stipulated in the Code, the overall situation of the organization is inspected, including personnel, equipment and facilities, documents, training and other aspects. Different aspects of the inspection focus is also different, personnel inspection can pay attention to personnel recruitment, training, appointment, files, assessment and other content; During the document management inspection, attention can be paid to the formulation, updating, archiving, receiving and recycling of documents such as organizational chart, laboratory plan, master plan, personnel list, instrument and equipment list, SOP and record form; Instrument management inspection can pay attention to the purchase, acceptance, use, maintenance, verification, verification, calibration, scrap and other aspects of the instrument; Subjects and controls can be concerned about their reception, description, identification, storage, use, disposal and other aspects. Facilities inspection should develop the corresponding SOP, and prepare the inspection plan, the inspection frequency can be based on the actual situation of the unit, can be once a year. In setting the frequency of inspections, consideration should be given to resource requirements and the impact on ongoing tests. Facility inspection can be carried out centrally in a certain period of time, complete a facility inspection in a short period of time, or it can be completed by time and stages in a designated work plan.
2.2.4 Others
In addition, QA should review the test plan and final test report as well as the raw data. The review of the test plan can be compared with all the elements in Article 34 of Chapter 9 of the Code, including the basic content of the test project, the test commission and the test institution, the date, the test method, other matters and records, and should also include all the information that the project leader guides the test personnel to complete the test project. Such as all Sops, forms to be filled, form filling requirements, etc. related to the test operation. QA reviews the final test report and original records, mainly checking whether the test report can accurately describe the test method, whether the test results can accurately reflect the original data in the test process, and evaluating the compliance of the test report, test data, test plan and SOP. When reviewing the final test report, QA should also review the original data, and the proportion of the original data should not be too small, at least more than 50% of the original data should be checked to ensure the accuracy of the test data and the authenticity of the report. When carrying out the inspection, QA shall record the inspection in detail, including the contents of the inspection, the problems found, the measures or recommendations taken, sign the name and date, and verify the completion of the rectification, and form an inspection report after the completion of all inspections, and send the report to the relevant SD and FM.
3 Test Facilities
The pesticide registration test unit shall have a dedicated test site that matches the test scope applied for, including various laboratories (such as balance room, pre-treatment room, instrument room, etc.), storage facilities for subjects, reference materials, samples and chemical reagents, test animal feeding and management facilities, file storage facilities and waste disposal facilities. Sops for the management of these test facilities should be established to ensure the normal operation of all types of test facilities.
The test site should have enough area, the instruments and equipment should be placed relatively centralized, and the areas that affect each other should be effectively isolated and non-interference. Access to and use of test areas should generally be controlled, areas that comply with the Code and non-Code should be distinguished and clearly marked, major and trace analysis areas should be physically isolated, pre-test treatment, different types of instruments and equipment should be placed reasonably; The design of electrical water pipes, lighting and ventilation facilities is conducive to carrying out tests and meeting safety requirements. If necessary, emergency facilities such as power outage and water outage should also be equipped; Environmental conditions shall be monitored, controlled and recorded when environmental conditions are required by relevant test specifications, methods and guidelines or affect the validity of results; There should be fire protection, safety protection, waste collection and treatment facilities that meet the requirements of the test, to ensure the safety of the test site and the health of personnel, and to regularly check and record whether these facilities are in good condition; Subject matter, reference, sample, chemical reagents, fire equipment, archives and other important facilities shall be managed by special personnel. Subjects, controls, samples and chemical reagents should have separate rooms or areas for receiving and storing. The storage conditions of subjects, controls and samples shall meet the requirements of the characteristics of the stored substances and test guidelines to ensure that the properties, content (concentration) and stability do not change. Meanwhile, the environmental conditions of the storage places of subjects, controls and samples shall be monitored, controlled and recorded. Chemical reagents and dangerous substances shall be stored safely and meet the relevant requirements of the State; Attention should be paid to fire prevention, anti-theft, moisture-proof, ventilation, strict control of personnel access, external personnel access should be recorded.
Experimental animal feeding facilities and management shall comply with relevant national regulations. Experimental animal feeding facilities should match the experimental projects they undertake, be reasonably designed, properly configured, dedicated and independent. Animal feeding facilities of barrier system should control human flow, logistics, animal flow and air flow direction; With the monitoring of temperature and humidity and pressure difference and other environmental conditions equipment, feeding facilities can adjust temperature and humidity, air cleanliness, ventilation and lighting according to requirements; There should be room and adequate area for diagnosis, treatment and control of diseases in experimental animals
Interpretation of ten elements of Quality Management Standard for Pesticide Registration Test
2023 11/02