Detailed Interpretation of Key Points in the “Quality Management Standards for Pesticide Registration Trials”

In 2017, the Ministry of Agriculture and Rural Affairs promulgated and implemented the “Quality Management Standards for Pesticide Registration Trials” (hereinafter referred to as the “Standards”). These Standards constitute a key regulatory document for the accreditation of pesticide registration trial facilities and serve as a code of conduct for conducting such trials. During their development, the Standards drew upon the core principles of the internationally recognized and authoritative Organisation for Economic Co-operation and Development (OECD) Good Laboratory Practice (GLP), while also taking into account China’s specific circumstances and the accumulated experience gained over many years of managing pesticide registration trials. The primary objective of issuing these Standards is to further strengthen the management of pesticide registration trials, ensure the authenticity and reliability of trial data, enable traceability throughout the trial process, and safeguard the scientific rigor and accuracy of the pesticide registration review. The Standards set forth ten specific requirements for pesticide registration trial facilities, covering organizational structure and personnel, quality assurance, laboratory facilities, instruments, materials and reagents, test systems, test substances, control substances and samples, standard operating procedures, implementation of test protocols, preparation of test reports, and archiving and storage. All test items involved in pesticide registration—such as product chemistry, efficacy, toxicology, residue studies, and environmental impact assessments—must comply with these requirements. This article, in conjunction with the technical review criteria for pesticide registration trial facilities, provides a detailed interpretation of the Standards’ ten elements, facilitating understanding and compliance by registration trial facilities, applicants, and other interested parties.

1 Organization and Personnel

Article 4 of the Regulations requires pesticide registration testing facilities to establish a comprehensive organizational management system, staffed with a facility director, project managers, quality assurance personnel, test personnel, archivists, and sample administrators, among others. The organizational management system comprises four key elements: organizational structure, resources, procedures, and processes. A well‑structured organizational management system for pesticide registration testing facilities should feature a clearly defined organizational structure, adequate staffing and fully equipped facilities and instruments, sound management systems, smooth internal operations, and effective oversight and supervision.

To apply to conduct pesticide registration trials, an organization must first establish an organizational structure that aligns with its quality management system. This structure should include at least a quality assurance department, a comprehensive coordination and support services department, and departments corresponding to the scope of the trials, with clearly defined roles and responsibilities for each unit. The organization must also staff these departments with management and technical personnel commensurate with the scope of the registration trials it intends to undertake. To ensure that personnel can effectively fulfill their duties, standard operating procedures (hereinafter referred to as SOPs) must be developed for all categories of staff, covering aspects such as qualification requirements, recruitment, training, authorization and appointment, as well as performance assessment and evaluation. Such personnel include institutional leaders, quality assurance officers, trial project managers, archivists, sample custodians, reference material administrators, trial technicians, instrument operators, and other technical and managerial staff. Furthermore, lawful employment or hiring relationships must be established with all employees, supported by valid documentation of employment status and the execution of formal service agreements.

1.1 Responsibilities of Key Personnel at the Testing Organization

The head of the testing institution (FM) is the highest-level manager of the testing organization, typically the legal representative or a person authorized by the legal entity. The FM assumes overall responsibility for the establishment and organizational management of the testing institution, ensures the provision of all necessary human and material resources to support the conduct of tests, and guarantees that the pesticide registration trials undertaken by the institution comply with the requirements of the “Standards.” The FM bears ultimate accountability for the institution’s operations. Under the “Standards,” the FM has 12 principal areas of responsibility.

The Study Director (SD) is the individual who bears overall responsibility for the execution and management of the assigned study. As the central figure in study implementation and oversight, the SD is accountable for both the study process and the final study report outcomes. The SD must possess a thorough understanding of the relevant technical expertise, be capable of accurately interpreting and applying the applicable test guidelines, promptly identify and scientifically assess any deviations that may arise during the study, and maintain a comprehensive and in-depth grasp of the requirements set forth in the Regulations and the documentation necessary for pesticide registration. The number of SDs should be commensurate with the scope of the studies undertaken, the specific study projects, and the actual workload involved. The SD is appointed, designated, or hired by the FM. Under the “Quality Management Standards for Pesticide Registration Studies,” the SD has ten principal areas of responsibility.

Quality Assurance (QA) personnel, in their role as supervisors, are responsible for providing continuous oversight of the operational activities of the trial site and the conduct of clinical trials. The most fundamental responsibility of QA is to ensure that the applicable regulatory standards are fully and effectively complied with throughout the trial site and during the course of the study, thereby providing evidence of the system’s effective operation. In performing their duties, QA personnel maintain a degree of independence; they must accurately and faithfully document any issues identified during oversight and promptly communicate with the Facility Manager (FM), Study Director (SD), and other relevant parties to uphold the impartiality and integrity of quality assurance. The regulations outline eight primary areas of responsibility for QA. Additionally, the guidelines specify the respective roles and responsibilities of trial investigators, archive managers, and sample management personnel.

1.2 Job Requirements

The head of the testing organization, the project leader, quality assurance personnel, the records administrator, and the sample administrator are designated as key positions, and their appointments must be strictly segregated within the organizational structure. The project leader may not concurrently hold overlapping roles across different pesticide registration test scopes. In the efficacy‑testing domain, a project leader for one type of test (e.g., insecticides) may not simultaneously serve as the project leader for another test category; similarly, in the environmental‑impact‑testing domain, the project leaders for ecotoxicology tests and environmental fate tests may not hold cross‑appointments. All staff members are prohibited from holding concurrent positions at two or more pesticide registration testing facilities accredited by the Ministry of Agriculture and Rural Affairs. Personnel from non‑accredited testing facilities who take on part‑time assignments at accredited institutions must obtain approval from their home institution and submit relevant supporting documentation. The number and composition of testing‑facility personnel, including their educational qualifications, technical background and experience, practical operational skills, and professional conduct, must align with the scope of testing, the specific projects undertaken, and the associated workload requirements. Project leaders are generally required to possess at least a bachelor’s degree in a relevant field and have no less than three years of hands‑on testing experience in that specialty. Quality‑assurance personnel typically need a bachelor’s degree in a related discipline and at least three years of experience in testing and quality‑assurance activities. Testing staff should hold at least an associate’s degree in a relevant field or have at least two years of testing experience. During their academic studies, individuals engaged in research within the relevant field may have their master’s or doctoral degrees recognized as equivalent to one or two years of testing experience, respectively. For senior technical personnel with long‑term experience at the grassroots level, the formal education requirements may be appropriately relaxed. It is important to emphasize that all personnel of pesticide registration testing facilities must complete training on the “Regulations,” applicable SOPs, and relevant professional skills before assuming their respective duties.

2 Quality Assurance

The “Regulations” set forth specific requirements for quality assurance activities at pesticide registration testing facilities, which can be summarized into the following five key areas: First, an independent Quality Assurance Unit (QAU) and dedicated Quality Assurance personnel (QA) must be established; the number, qualifications, experience, and training of the Quality Assurance Manager (QAM) and QA staff must meet the job‑specific requirements. Second, QA personnel should possess a solid technical background and relevant experience in quality assurance, be thoroughly familiar with the Regulations, the test procedures, and the management requirements for pesticide registration testing facilities, and demonstrate strong communication and execution skills. They are appointed directly by the Facility Manager and report directly to them. Third, they must not participate in the test projects under review. Fourth, a quality assurance plan must be developed, and various inspection activities carried out, to ensure that all assigned test projects comply with the Regulations. Fifth, when multi‑site testing is conducted, the entire process of each test project and all participating sites must also adhere to the requirements of the Regulations.

2.1 QAU  

QAU is the core of implementing the Quality Management System under the “Regulations,” and its primary functions are as follows: first, to serve the testing organization itself by supporting and collaborating with SD to ensure high‑quality completion of test tasks, thereby fostering a relationship of mutual cooperation and assistance; second, to promptly identify issues and address them at an early stage, thereby reducing the risk of substandard test reports, non‑compliance, rejection by pesticide registration review authorities, or challenges, and ensuring that the safety‑testing data submitted to the pesticide registration management authorities are authentic, reliable, complete, and traceable; third, to safeguard the legitimate interests of the commissioning party and minimize unnecessary disputes; and fourth, to prevent and mitigate problems arising during external reviews.

2.2 QA

To ensure that every stage and process of the trial complies with the requirements of the Regulations, QA must conduct a series of inspections and develop corresponding Standard Operating Procedures (SOPs). The primary focus of QA inspections is typically not on technical aspects, but rather on verifying whether the trial adheres to regulatory requirements and is conducted in accordance with the trial protocol and SOPs. Prior to carrying out inspections, QA should prepare an inspection plan, which—based primarily on the trial protocol and master schedule—defines the scope of the inspection, the timing of its execution, and assigns specific responsibilities to QA personnel. QA inspections are generally categorized into three types: trial‑specific inspections, process inspections, and facility inspections.

2.2.1 Inspection of Test Items

Inspection of test items shall cover every individual test item. In general, it is not necessary to inspect every step of each item; instead, key steps should be selected. Key steps are those that pose risks, are critical, have significant impacts, and are representative of the entire testing process. QA shall ensure that at least one or more key steps in each project can be inspected on-site.

2.2.2 Process Inspection

Process inspections are generally not focused on specific test items; rather, they target repetitive or routine testing procedures or steps that cannot be adequately assessed or effectively monitored through routine testing. Examples include reference material management, solution labeling, instrument usage records, and waste disposal. When conducting process inspections, QA should also develop a formal inspection plan, specifying the prescribed frequency—such as every three or six months. Additionally, ad hoc, targeted process inspections may be initiated to address emerging issues in the laboratory—for instance, if unexplained interferences arise during testing. In such cases, after ruling out factors like instrument performance or operator error, QA might arrange an inspection of the laboratory’s glassware‑washing procedure to ensure that staff are adhering to the relevant SOPs. Process inspections must not be used as a substitute for testing‑item‑specific inspections.

2.2.3 Facility Inspection

Facility inspections, also known as institutional inspections, focus on the overall facilities and functionality of a testing organization and provide a comprehensive, holistic assessment of the institution’s compliance with the relevant standards. These inspections are not project‑specific; instead, they evaluate the organization’s general operations across the ten elements stipulated in the standards, covering personnel, equipment and facilities, documentation, training, and other key areas. The specific emphasis varies by domain: during personnel reviews, attention is given to recruitment, training, appointment procedures, personnel records, and performance evaluations; for document management, the focus is on the preparation, updating, archiving, issuance, and retrieval of organizational charts, laboratory floor plans, master schedules, personnel rosters, equipment inventories, SOPs, and record‑keeping forms; instrument management assessments address procurement, acceptance, use, maintenance, verification/calibration/adjustment, and decommissioning; and for test articles and reference materials, considerations include receipt, characterization, labeling, storage, usage, and disposal. Facility inspections should be conducted in accordance with established SOPs, and a detailed inspection plan must be developed. Inspection frequency may be determined based on the organization’s specific circumstances, with annual reviews being a common practice. When setting the inspection schedule, factors such as resource requirements and potential impacts on ongoing testing activities should be carefully weighed. Inspections can be carried out in a concentrated, short‑term effort within a defined period, or they may be implemented according to a structured, phased work plan over time.

2.2.4 Other

In addition, QA shall review the study protocol, the final study report, and the raw data. The review of the study protocol should be conducted against all the elements specified in Article 34 of Chapter 9 of the Regulations, covering six aspects: the basic content of the study, details of the sponsor and the testing institution, dates, test methods, other relevant matters, and record‑keeping. It should also include all information provided by the project leader to guide the study personnel in completing the study, such as all SOPs related to test procedures, the forms to be completed, and the requirements for filling out those forms. When reviewing the final study report and the raw records, QA shall primarily verify whether the report accurately describes the test methods, whether the results precisely reflect the original data generated during the study, and whether the report and the data comply with the study protocol and the applicable SOPs. During the review of the final study report, QA should also examine the raw data; the proportion of raw data inspected should not be too small—no less than 50%—to ensure the accuracy of the study data and the authenticity of the report.

During inspections, QA personnel shall maintain detailed records, documenting the inspection scope, identified issues, and any corrective actions or recommendations taken, and shall sign and date the records. They must also verify the completion of corrective measures. Upon conclusion of all inspections, a formal inspection report shall be prepared and forwarded to the relevant SDs and FMs.

3 Test Facilities  

Pesticide registration testing facilities must be equipped with dedicated premises that are commensurate with the scope of the tests being proposed, including various types of laboratories (such as balance rooms, sample preparation rooms, and instrument rooms), storage facilities for test substances, reference materials, samples, and chemical reagents, animal housing and management facilities, archival storage facilities, and waste disposal facilities. Standard operating procedures (SOPs) for the management of these testing facilities should be established to ensure their proper operation.

The testing facility shall have sufficient floor space, with instruments and equipment grouped in a centralized location, and areas where equipment may interfere with one another effectively segregated to prevent mutual disruption. Access to and use of the testing area should generally be controlled; compliance with “regulated” versus “non‑regulated” zones must be clearly distinguished and conspicuously marked. Areas for macro‑ and trace‑level analyses should be physically separated, and pre‑analytical processing areas as well as different types of instruments and equipment should be arranged appropriately. Electrical and plumbing systems, lighting, and ventilation facilities should be designed to facilitate testing while meeting safety requirements; where necessary, emergency provisions for power and water outages should also be provided. When relevant test specifications, methods, or guidelines impose requirements on environmental conditions, or when such conditions may affect the validity of results, environmental parameters must be monitored, controlled, and recorded. The facility shall be equipped with fire‑protection, safety‑guarding, and waste‑collection and disposal systems that meet testing needs, ensuring the safety of the premises and the health of personnel; these systems should be inspected and documented regularly to confirm they remain in good working order. Critical items—including test articles, reference materials, samples, chemical reagents, fire‑fighting equipment, and archives—should be managed by designated personnel. Test articles, reference materials, samples, and chemical reagents must each have their own dedicated receiving and storage rooms or areas. Storage conditions for test articles, reference materials, and samples must comply with the characteristics of the stored substances and the requirements of the applicable test protocols, ensuring that their physical properties, content (concentration), and stability remain unchanged. At the same time, environmental conditions at the storage locations for test articles, reference materials, and samples must be monitored, controlled, and recorded. Chemical reagents and hazardous substances must be stored safely in accordance with relevant national regulations. Precautions against fire, theft, and moisture, as well as adequate ventilation, must be observed, and access by personnel should be strictly regulated; entries and exits by external visitors must be duly recorded.

The facilities and management of laboratory animals shall comply with relevant national regulations. Such facilities must be appropriately matched to the experimental projects they support, designed rationally, adequately equipped, and dedicated and independent. Barrier‑system animal housing facilities shall control the flow of personnel, materials, animals, and air; they must be equipped with devices for monitoring environmental parameters such as temperature, humidity, and pressure differentials, and capable of regulating these conditions—including temperature, humidity, air cleanliness, ventilation, and lighting—according to specified requirements. Sufficient space and rooms must be provided for the diagnosis, treatment, and control of animal diseases. Storage facilities for feed, bedding, cages, and other supplies shall be in place, with all equipment arranged appropriately to prevent cross‑contamination with the experimental system. Relevant monitoring and management records shall be established and maintained.

Based on the scope of the study, provide planting and aquaculture facilities with sufficient area and effective containment for plants and aquatic organisms, including terrestrial species. The management of these facilities shall comply with the requirements of the relevant test guidelines, SOPs, and the study protocol.

Archival facilities shall provide adequate space for the storage of records, and their design and environmental conditions must meet the requirements for the long-term safe preservation of the materials stored. They shall incorporate measures to protect against fire, theft, insects, rodents, and mold. An archival management system shall be established to facilitate classification, retrieval, and access, with strict control over personnel entry and exit, accompanied by appropriate record-keeping.

There are fire‑fighting, safety‑protection, and waste‑collection and storage facilities that meet the requirements of the tests. Waste is stored in accordance with applicable regulations, sorted into appropriate categories, and clearly labeled to ensure the safety of the test site and the health of personnel. These facilities shall be inspected regularly, and records kept to verify that they remain in good working condition.

The handling of waste materials and animal carcasses shall comply with relevant national regulations, and records of disposal shall be maintained.

4 Instruments, Materials, and Reagents

Equip the facility with instruments and equipment that meet the requirements of the test scope, as well as the necessary materials and reagents for testing. Sufficient space must be provided to ensure proper storage of all types of instruments, equipment, and consumable supplies used in testing. Instruments, materials, and reagents shall be managed by designated personnel, and separate SOPs shall be established for the management of instruments and equipment, materials, and reagents. All instruments, materials, and reagents used in testing must not introduce interference or contamination into the test system.

4.1 Instruments

Establish an instrument and equipment inventory, including at a minimum the instrument name, unique identification number, model and specifications, date of acquisition, dates of verification/verification/calibration, and the next scheduled verification/verification/calibration date.

Establish instrument and equipment records, including the instrument name, unique identification number, model and specifications, factory serial number, manufacturer, date of acquisition and purchase price, date of receipt, acceptance and commissioning records, date of initial use, user manual, installation location, details of all previous verification/calibration/adjustment activities or self‑calibration procedures, as well as records of periodic checks, usage, maintenance, damage, malfunctions, and repairs.

Establish standard operating procedures (SOPs) for the operation of instruments and equipment. In accordance with these SOPs, ensure proper use, regular maintenance, validation/verification/calibration, and in‑process checks, and maintain documented records. Instruments and equipment that may affect the accuracy or validity of test results—including auxiliary measuring devices used to monitor environmental conditions—shall be subject to scheduled validation, verification, or calibration, with traceability to national standards whenever possible. Measuring instruments, such as weights, burettes, volumetric flasks, and pipettes, must also undergo periodic calibration. Functional instruments should be regularly inspected to confirm proper operation, and SOPs for functional testing and management should be established to ensure they remain in good working condition. Each instrument or piece of equipment shall be clearly labeled to indicate its current validation, verification, or calibration status. Prior to commissioning, verify that the instrument or equipment meets the requirements of the relevant tests. All instruments and equipment shall be operated by authorized personnel and subjected to routine maintenance.

Instrumentation and equipment shall maintain usage records. These records shall meet the requirements for test reproducibility and traceability, and shall include the start-up time, shut-down time, sample number, status of use (including maintenance, inspection, repair, etc.), environmental conditions, and the operator’s name.

General laboratory instruments and equipment shall not be leased for use. However, when special circumstances necessitate the use of leased instruments and equipment, the following requirements must be met: First, the management of leased instruments and equipment shall be integrated into the management framework of this testing organization; second, the organization shall have full authority over their use—meaning that personnel of the organization shall operate, maintain, and verify/inspect/calibrate the leased equipment, and shall control the operating environment and storage conditions; third, a formal lease agreement must be in place, clearly stipulating the rights to use the leased equipment for at least one accreditation cycle; and fourth, such equipment may not be simultaneously leased by different organizations.

4.2 Materials and Reagents

Materials and consumables such as reagents shall be effectively controlled and managed. Procurement, acceptance, issuance, use, and storage must be conducted in accordance with established SOPs to ensure the quality of experimental results. Materials and reagents shall be stored according to their physical and chemical properties—e.g., organic/inorganic, solid/liquid, acidic/basic, flammable, explosive—and environmental conditions shall be strictly monitored. Inbound and outbound records must be maintained to ensure consistency between inventory records and physical stock. Large quantities of chemical reagents should be stored in a dedicated reagent storage facility. Suppliers of materials and service providers shall be evaluated on a regular basis, with records of these evaluations retained and a list of approved, qualified suppliers and service providers maintained. Precursor chemicals and other restricted reagents must be stored in designated cabinets, secured with dual locks and managed by two authorized personnel; dispensing shall be measured and documented, and relevant records completed. Purchases shall be made in compliance with applicable regulations.

5 Experimental System

An experimental system, also referred to as an experimental setup, encompasses any biological, chemical, or physical system used in testing, or any combination thereof. The testing organization shall establish standard operating procedures (SOPs) for managing experimental systems. For physical and chemical experimental systems: first, the facilities must be appropriately designed and provide sufficient space; second, instruments and equipment must be properly positioned and maintained, with quantities and functionalities aligned with the experimental requirements; third, the integrity, stability, and compliance of these systems must be ensured to prevent cross-contamination. For biological experimental systems, particular attention should be paid to carefully monitoring and documenting factors such as the growth environment, developmental status, and treatment regimens. Experiments should be conducted in accordance with the established growth patterns of the system to minimize interference from contaminants. In field trials involving pesticide residues or efficacy, measures must be taken to prevent drift from spray applications and to mitigate the impact of previously applied pesticides. When selecting experimental plots, efforts should be made to minimize potential sources of experimental interference. Additionally, sprayers used for pesticide application should be assigned unique identifiers based on the specific pesticide category to which they are intended.

6 Test substance, control substance, and sample

6.1 Test Substance

A standard operating procedure (SOP) for test article management shall be established, specifying requirements for receipt, sample retention, labeling, retrieval, transfer, use, storage, and disposal of test articles. The SOP shall include a system for assigning unique identifiers and numbers to test articles, which must bear distinct identification codes, and shall incorporate status markings throughout the testing process.

Test items shall be entrusted to a designated custodian, with measures in place to ensure that, throughout the entire process—from receipt and sample retention, through labeling, storage, issuance, circulation, use, return, and final storage—there is no confusion, loss, damage, or deterioration. Upon receipt, test items must be inspected and weighed to verify that all relevant information is complete and accurate. If any doubts arise, or if the information is incomplete or inconsistent with the supplier’s documentation, further clarification must be obtained. The information to be verified and recorded shall include, at a minimum: the pesticide name (including active ingredient, concentration, and formulation), a unique identification number, the seal‑number, the date of manufacture or batch number, the shelf life, physical appearance, quality, details of the commissioning party, the receiver, and the date of receipt. Only after such verification may the items be placed in storage. During the distribution and return of test items, the sample administrator shall meticulously confirm the identity of the recipient, the condition of the item at the time of issuance, the time of issuance, the condition upon return, and the identity of the person returning the item, obtain signatures, and maintain appropriate records. Test items must be stored in designated categories under secure conditions to prevent degradation, contamination, loss, or damage during storage. Storage shall comply with the specific environmental requirements for each type of test item, with regular monitoring and recording of storage conditions, and documentation retained for future reference. The retention period for test items shall be determined in accordance with applicable laws and regulations and the client’s requirements. Disposal of test items must be documented, clearly specifying the quantity, name, and date of disposal; the personnel involved and the disposal procedures must conform to national regulations.

6.2 Reference Materials and Samples  

A standard operating procedure (SOP) for reference material management should be established, covering receipt or procurement, issuance, use, storage, and eventual disposal. A reference material identification system should be implemented, with each item assigned a unique identifier upon entry into the laboratory. Reference materials must bear clear labels indicating the active ingredient, content (or concentration), quantity, unique identification number, and expiration date. Dedicated personnel should be responsible for their custody, maintaining a detailed ledger that includes the name of the active ingredient, its content (or concentration), quantity, unique identifier, batch number, expiration date, storage conditions, and relevant information on periodic verification. Records of use must be kept. Upon issuance, use, and return, the reference material administrator shall verify the material’s quality. Reference materials shall be stored in accordance with the temperature requirements specified on their certificates, with corresponding records maintained. Only reference materials accompanied by valid certification should be purchased. The preparation, standardization, calibration, and periodic re‑verification of standard solutions must comply with applicable test standards and guidelines, with all procedures documented. Adequate storage facilities meeting the required specifications must be provided.

A standard operating procedure (SOP) for sample management should be established, with relevant management practices referencing those for the test article.

7 Standard Operating Procedure

A Standard Operating Procedure (SOP) is a documented set of instructions that outlines the routine or repetitive work processes, management practices, and experimental methods employed within a testing organization, thereby ensuring consistency among personnel and guaranteeing the quality and integrity of test data, as well as the traceability of the data-generation process.

The SOP development process typically begins with each department submitting its requirements, followed by management assessing their necessity and assigning the FM team to draft the document. The initial draft is prepared by personnel familiar with the relevant work, then reviewed and refined by the department or other concerned parties. The department head conducts a preliminary review, after which QA performs a final review and the FM approves the SOP. SOPs should comply with regulatory requirements, align with the organization’s specific circumstances, and be practical, straightforward, and easy to understand. All departments within the testing organization must have timely access to the latest versions of the SOPs relevant to their functions, and relevant personnel should promptly undergo training and maintain records of their learning.

SOPs typically include the following formal elements: the name of the testing unit, the SOP’s identification number, page numbers, the author’s signature and date, the reviewer’s signature and date, the approver’s signature and date, the date of issuance, the effective date, and a revision history. The main content elements must at least comprise the title, purpose, scope, body, record forms, references, appendices, and a revision history.

SOPs shall be revised periodically, and the revision process shall be documented. The development, revision, distribution, withdrawal, and destruction of SOPs shall all be recorded and archived.

Key considerations in developing SOPs: First, the content should neither be overly detailed nor too sparse. Some testing organizations’ SOPs include excessive minutiae, leading to frequent deviations from standard procedures, while others lack sufficient detail, compromising process traceability. Second, outdated SOP versions should not be kept on-site. Third, testing organizations must provide clear instructions on where and how SOPs are to be accessed. Fourth, because electronic SOPs can be difficult to view or use at the test site, uncontrolled hard‑copy duplicates may arise. Fifth, it is recommended to distribute SOPs centrally and retrieve older versions. Sixth, SOPs should be reviewed every two to three years to assess their practical effectiveness and revised as needed. Testing organizations must maintain an up‑to‑date inventory of SOPs, with dates clearly recorded, and archive the current original version. One original copy is sufficient; duplicate copies should be distributed to the relevant test locations.

Management of electronic SOPs. Conditions for using electronic SOPs are as follows: first, ensuring that the electronic SOP files cannot be altered; second, displaying only the current version; third, enabling accurate identification and management of printed copies of the SOPs, with corresponding records maintained by SOP‑management personnel approved by the FM; and fourth, requiring a specialized document‑management approach for handling electronic SOPs.

8 Implementation of Test Projects

8.1 Main Contents of the Test Plan

Prior to the initiation of a test project, a written test plan shall be prepared and the tests shall be conducted in accordance with that plan. Due to variations in the scope and nature of the project, the content, duration, personnel requirements, resources, and level of complexity of the plan will differ. The test plan shall include at least the following elements: basic information about the test project (project name, nature and objectives, name and identification code of the test article, proposed control substances and their sources, and other essential details); details of the commissioning party and the testing organization (name of the commissioning entity or name and address of the principal, name and address of the testing organization and any relevant test facilities, name of the project manager, names of sub‑project managers along with the specific test phases they oversee and their respective responsibilities); relevant signatures and dates (signature of the project manager, signature of the head of the testing organization, date on which the commissioning party approves/acknowledges the test plan and signs it, as well as the anticipated start and completion dates of the tests); test methods (the methods to be employed, including national standards, industry standards, and other recognized international organizational test guidelines and procedures); additional matters (to be selected based on the specific requirements of the test scope); and a list of records that are required to be retained.

It is particularly important that the test plan include the full anticipated timeline for all tests, the relevant SOPs to be referenced (where applicable), the preparation of various solutions, animal housing conditions (e.g., quarantine, space, cages, temperature, humidity, lighting, and diet), sample analysis, and data evaluation (including mean values, standard deviations, and criteria for accepting or rejecting data).

8.2 Review and Approval of the Test Plan

The test plan should generally be reviewed by quality assurance personnel and approved by the test project leader; when necessary, it must also be signed off by the head of the testing institution and the commissioning party. The project leader is responsible for the scientific and technical soundness of the project, the quality assurance officer ensures compliance and oversees the implementation of the plan, and the institutional head is responsible for allocating resources such as personnel, facilities, and materials. The project commissioning party shall be informed of the plan’s contents and timeline and determine whether the project’s objectives have been met. Any revisions to the test plan must be clearly justified, approved by the test project leader, and, if required, endorsed by the commissioning party. The revised test plan shall be retained together with the original. If deviations occur during implementation, the test project leader shall document them in detail, specifying the reasons for the deviation. For example, in pharmacological efficacy studies or field residue trials, adverse weather conditions may prevent adherence to the planned schedule. Depending on the extent of the deviation, the commissioning party shall be notified. The project leader shall sign the document, indicate the date, and retain it along with the original data. For short‑term tests, a standard test plan may be used, supplemented by specific requirements for each individual assay. Short‑term projects typically cover physicochemical properties, acute toxicity, mutagenicity, and acute ecotoxicology, with a duration not exceeding one week.

8.3 Other Requirements of the Project Plan and Project Implementation  

The project plan should include a numbering system, page numbers, and a total page count. A logical and practical numbering scheme should be employed to ensure that it can effectively guide all project participants throughout the implementation process. The information contained in the project plan should be limited to what is strictly necessary for the ongoing execution of the project. The project plan—such as schedules and timelines—should remain flexible, provided that such flexibility does not adversely affect the project itself.

During the conduct of trials, special attention should be paid to the following: First, each trial shall be assigned a unique identification number, prominently displayed on every page of the trial protocol, and consistently applied to all samples, records, and documents associated with that trial, enabling traceability of both the test samples and the trial process. Second, trials must be conducted in accordance with the approved protocol. The SD is fully responsible for the operational management of the project, and trial personnel shall carry out their tasks as specified in the protocol. All relevant parties involved in the trial must clearly understand the contents of the protocol, their specific responsibilities, the timing of their activities, and the locations where they are to be performed. Any deviation from the approved protocol—whether positive or negative—must be promptly reported to the project leader. In the event of a change in project leadership or termination of the project, the institutional head shall confirm and sign off on the documentation, which shall then be archived together with the trial protocol. Third, original data comprise the raw observational records and related documentary materials generated during the course of the trial, including work logs, photographs, microfilm, microfiche, computer printouts, magnetic media, and automated instrument‑generated records. The trial site shall establish standard operating procedures (SOPs) for record‑keeping. Any modification to original data must be carried out in strict compliance with these SOPs; the rationale for each change must be clearly noted alongside the amended entry, and prior entries must not be obscured or overwritten. Furthermore, the individual making the change must sign the record and indicate the date of the amendment. Original data records must be stored securely. Fourth, for data entered directly into a computer system, the data entry personnel must verify the information accurately before proceeding. The computer system must maintain a complete audit trail documenting all modifications and verifications. When data are modified, the reasons for the change and the date of the modification must be explicitly stated and recorded.

In summary, the test plan serves as a communication tool between the testing organization and the client, and it is an essential document for replicating completed projects. It acts as a driving force to ensure that the project is conducted in accordance with the relevant standards. Each project must have an approved test plan, which must contain sufficient information. The development of the test plan should be guided by the project’s objectives and the needs of its intended users, and it must comply with the requirements of the applicable standards.

9 Test Report

Each test project shall be accompanied by a test report. For short‑term tests, the report may typically consist of a standardized template supplemented by a separate section detailing the test results. The test report serves as the submission document that pesticide registration testing facilities provide to the pesticide registration authority and constitutes the primary basis for the review process; therefore, such facilities must accord it the highest priority, prepare it meticulously, and ensure its accuracy. The report must contain complete information, bear all required signatures, and employ precise language. The test procedures and methods should be described in sufficient detail. Raw data must be faithfully recorded and free from errors. The report’s content must comply with the requirements set forth in the relevant regulatory standards.

If the test report is prepared by the person responsible for the specific test item or by the testing personnel, this shall be clearly indicated in the report. The test project leader shall carefully verify the report and sign it with the date, assuming responsibility for the authenticity, validity, and completeness of the data. The leader must also state the extent to which the report complies with the relevant standards and the test plan, identify any deviations, and assess their impact on the test results. If the test report is revised, the reasons for the modifications or additions must be clearly and thoroughly explained, and the revision shall be signed and dated by the test project leader. In accordance with the “Requirements for Pesticide Registration Data,” when the format of the test report is adjusted or rearranged, no changes or additions may be made to the report’s content. At the request of the commissioning party, the testing institution may issue a copy of the final test report, provided that such copy remains consistent with the original.

10 Archiving and Preservation

The laboratory must establish SOPs for record management and for the submission of materials to prevent data loss and tampering. Records and materials related to organizational management that require archiving shall include, at a minimum: an organizational chart; personnel files containing resumes, qualifications, training records, proof of experience, and job descriptions; appointment and authorization documents for all staff; laboratory floor plans; summary tables of completed projects; instrument and equipment dossiers, including records of acquisition, installation, acceptance testing, validation/verification/calibration, usage, and maintenance; validation documentation for computerized systems; standard operating procedures in all versions along with revision logs; purchase records for consumables and supplier evaluation records; waste‑management records, including contracts, waste types, and quantities; and all inspection records maintained by quality‑assurance personnel.

Records and materials that must be archived for a project include, at a minimum: the study protocol, the contract agreement, raw data, detailed information on test articles, control substances, samples, and specimens, environmental monitoring records, the final study report, and the master schedule; as well as other project‑related documents (e.g., WeChat and telephone communication logs). For example, in a toxicology study, the required records and materials should include, at a minimum: documentation for each animal (source, health status, treatments, quarantine, measurements, and clinical observations); documentation pertaining to feed, water, and bedding (source, quality, analytical results); environmental monitoring records from the animal facility; information on the test article (stability, homogeneity, etc.); pathological findings (gross and microscopic); and specimens used to generate the study results (formalin‑ or alcohol‑fixed tissues, paraffin blocks, slides, smears), among others.

The archive room shall be access‑controlled; entry is permitted only with FM approval and must be documented. All necessary filing cabinets shall be locked. The archive room shall maintain appropriate temperature and humidity levels and be protected against fire, theft, pests, rodents, water damage, earthquakes, and tampering. Standard Operating Procedures (SOPs) for the submission of records and materials shall be established to prevent data loss or alteration. Archivists shall record all incoming and outgoing materials, and upon return, archival management should, to the extent possible, inspect returned items for any damage or missing components. The retention period for archived materials shall comply with applicable regulations. Records and materials scheduled for destruction must be accompanied by complete documentation.

11 Summary

Over the five years since its implementation, the “Regulations” have played a significant role in standardizing the management of pesticide registration‑testing institutions and enhancing the quality of test reports. As China’s capacity and expertise in pesticide safety assessment continue to improve, and as the quality of pesticide registration tests and related research evolves, it is expected that the quality standards for pesticide registration testing will be further refined and adjusted to meet the needs of industry development and regulatory oversight.

Source: Modern Pesticides Issue No. 4, August 2023 Authors: Zong Fulin and Ji Ying, Pesticide Inspection Institute, Ministry of Agriculture and Rural Affairs