GB/T 27406-2025Criterion on the quality control of laboratories - Food toxicology testing (English PDF)

3.1 Food toxicology testing laboratory

An experimental facility that uses toxicological methods to test and evaluate food-related substances.

NOTE: food-related substances include food and its raw materials, food additives, and substances in food containers and packaging materials that may be ingested through food.

3.2 Top management of laboratory

The person or group of people who directs and controls the laboratory at the highest level.

3.13 Administration

The operation of administering test material to a test system in a specific manner.

3.14 Dose

The amount of test material administered to a test system in a test.

3.15 Dose-effect relationship

The correlation between the dose of a chemical and its effect in an individual.

3.16 Dose-response relationship

The correlation between the dose of a chemical and the intensity of response it elicits in a population.

4.1 Impartiality

4.1.1 Food toxicology laboratories shall impartially conduct laboratory activities and ensure impartiality in their organizational structure and management.

4.1.2 The top management of laboratories shall make an impartiality commitment.

4.1.3 The laboratories shall be responsible for the impartiality of their laboratory activities and shall not allow commercial, financial, or other pressures to compromise impartiality.

4.1.4 The laboratories shall continuously identify risks that could affect impartiality. These risks shall include those arising from laboratory activities, various relationships within the laboratory, or relationships among laboratory personnel. However, these relationships do not necessarily pose a risk to the laboratories' impartiality.

NOTE: relationships that could compromise the laboratories' impartiality may be based on ownership, right of control, management, personnel, shared resources, finances, contracts, marketing (including brand promotion), sales commissions to referrals of new clients, or other benefits.

4.1.5 If an impartiality risk is identified, the laboratories shall be able to demonstrate how to eliminate or minimize such risk.

4.2 Confidentiality

4.2.1 Food toxicology laboratories shall assume management responsibility for all information obtained or generated during laboratory activities by making a legally binding commitment.

The laboratories shall notify clients in advance of any information that they intend to disclose.

Unless the information is publicly disclosed by the clients, or there is an agreement between the laboratories and the clients (e.g., for the purpose of responding to a complaint), all other information is considered proprietary and shall be kept confidential.

4.2.2 When the laboratories disclose confidential information as required by law or authorized by contract, they shall notify the relevant clients or individuals of the information provided, unless prohibited by law.

4.2.3 When the laboratories obtain information about a client from channels other than the client (for example, complainants or regulatory agencies), they shall maintain confidentiality between the client and the laboratories. Unless the information provider agrees, the laboratories shall keep the information confidential for the information provider (source) and shall not disclose it to the client.

4.2.4 Personnel, including members of the Laboratory Animal Welfare and Ethics Committee and other committees, contracted personnel, external agency personnel, or individuals representing the laboratories, shall maintain confidentiality for all information obtained or generated in the course of laboratory activities, except as required by law.

6.1 General Requirements

The laboratories shall have the personnel, facilities, equipment, systems and support services necessary to manage and conduct laboratory activities.

6.2 Personnel

6.2.1 All personnel who may affect laboratory activities, whether internal or external, shall impartially act, be competent, and work in accordance with the requirements of the laboratory management system.

6.2.2 The technical director or authorized signatory shall be a person with a background in medicine/preventive medicine, biology, pharmacy, or a related field. The technical director or technical management shall be responsible for at least.

a) Providing clients with consultation on relevant policies, regulations, technical documents, and result interpretation, etc.;

b) Ensuring that there are appropriate standard operating procedures (SOPs) for study operations and ensuring their strict implementation;

c) Appointing a study director before the commencement of study work. If the candidate for this position needs to be changed during the study, it shall be recorded;

d) Approving the study protocol and issuing test reports;

e) Evaluating, selecting and monitoring external laboratories (where applicable).

6.2.3 The quality director shall be a person with a relevant professional background and who has received specialized quality management training. The main responsibilities include.

a) Ensuring effective operation and continuous improvement of the quality system;

b) Ensuring the implementation of quality assurance measures during study;

c) Handling complaints, requests or opinions from clients and relevant parties;

d) Effectively liaising with and working with the following parties (including entering into agreements when necessary).

---The clients served;

---Relevant management departments;

---Relevant management agencies responsible for food safety;

---Relevant agencies responsible for laboratory accreditation management.

e) Conducting internal audits.

6.2.4 The study director is responsible for the entire process of a study project and shall accept guidance from the technical director. The study director's responsibilities include at least.

a) Proposing the study protocol;

b) Ensuring the study is conducted in accordance with the study protocol and corresponding SOPs. Any deviation from the study protocol shall be evaluated and confirmed in accordance with procedures, and records of changes and reasons for changes shall be filed;

c) Ensuring all original data is completely, authentically and promptly recorded;

d) Being responsible for the validity of the test data and the compliance of the study process with the requirements of this criterion;

e) Ensuring that after the study, the study protocol, study report, original data, and other relevant materials are promptly archived and preserved;

f) Reviewing the test report.

6.2.5 Study personnel shall accept guidance from the study director, strictly follow the study protocol and SOPs, implement quality assurance measures during the study, safely operate, and minimize the risks of their own study operations. If the study personnel are aware that their health condition or any medical measures, for example, medication, may adversely affect the quality of a study, they shall withdraw from the corresponding study process.

6.2.6 The quality supervisor shall be appointed by the top management of laboratories and shall be familiar with the study they are responsible for supervising and controlling. The laboratories shall have at least one full-time quality supervisor. The duties of the quality supervisor shall include at least.

a) Confirming that study personnel have received the study protocol and relevant SOPs;

b) Supervising whether the study has been conducted in accordance with the requirements of the study protocol and SOPs, and whether quality assurance measures have been implemented. The quality supervisor shall regularly inspect laboratory work and/or audit the study process, and record the results of inspections and audits;

c) Immediately notifying the study director or reporting to the quality director and recording any unauthorized deviations from the study protocol and/or SOPs or failure to implement quality assurance measures;

d) Inspecting study reports to ensure that the study methods, study process and observation results are accurately described, and that the results accurately reflect the original data;

e) Signing a declaration in the draft report, including the dates of regular inspections and audits, as well as any problems found and the dates on which the problems were reported.

6.2.7 Laboratory personnel shall receive specialized training in quality management related to laboratory services. Personnel in different positions shall participate in appropriate continuing education programs. For personnel in specialized positions, such as animal study operators and slide readers (genetic toxicology and pathology, etc.), specialized technical training shall be provided, and appropriate qualifications or authorizations need to be obtained.

6.2.8 Personnel shall be trained on how to prevent accidents and how to control accidents that have already occurred. The personnel's ability to handle accidents shall be assessed, and multiple training sessions and assessments shall be conducted as necessary.

6.2.9 Laboratory personnel shall possess knowledge of biosafety and disinfection procedures.

Laboratory auxiliary personnel shall receive appropriate training and possess basic theoretical knowledge and practical skills.

6.2.10 The laboratories shall be staffed with veterinary professionals responsible for the quality of laboratory animals and the inspection and implementation of facilities used.

6.2.11 The laboratories shall document the competency requirements for each function/position affecting the results of laboratory activities, including requirements for education, qualifications, training, technical knowledge, skills and experience.

6.2.12 The laboratories shall ensure that the personnel possess competence for the laboratory activities they are responsible for, and the ability to assess the impact of deviations. Records demonstrating their competence shall be maintained, which may include.

a) Academic qualifications, degrees, and certifications, appointment letters;

b) Technical work resumes and relevant employer evaluations (where applicable);

c) Job descriptions;

d) Records of continuing education and achievements;

e) Records of relevant scientific activities, including published academic papers, research projects participated in, and certificates of achievement, etc.;

f) Competency assessments and evaluations;

g) Records of measures taken to address errors or incident handling;

h) Health and medical examination records.

6.2.13 The top management of laboratories shall communicate their responsibilities and authority to laboratory personnel.

6.2.14 The laboratories shall have procedures for the following activities and maintain relevant records.

a) Determining competence requirements;

b) Personnel selection;

c) Personnel training;

d) Personnel supervision;

e) Personnel authorization;

f) Personnel competence monitoring.

6.2.15 The laboratories shall authorize personnel to perform specific laboratory activities, including but not limited to the following.

a) Developing, modifying, validating and certifying methods;

b) Analyzing results, including statements of conformity or opinions and interpretations;

c) Reporting, reviewing and approving results;

d) Specific activities, such as animal husbandry, animal quarantine, animal dissection, sampling, testing, operation of specific types of instruments and equipment, operation of laboratory information systems, access to client confidentiality and test results, and correction of computer programs, etc.

6.3 Facilities and Environmental Conditions

6.3.1 Facilities and environmental conditions shall be suitable for laboratory activities and shall not adversely affect the validity of results. Food toxicology laboratories shall also have dedicated animal husbandry facilities, obtain animal use permits issued by national or provincial authorities, and meet the following requirements.

a) Sufficient usable area, with a reasonable layout, and equipped with environmental monitoring facilities, such as cleanliness, temperature, humidity, ventilation, ammonia concentration, and lighting control, etc.;

b) Animals of different strains shall be respectively housed in separate spaces, and sick animals shall be isolated;

c) If necessary, specialized laboratory animal rooms shall be provided for animal experiments involving radioactive materials and microorganisms. These specialized laboratory animal rooms shall be completely separated from conventional laboratory animal rooms, including ventilation and sewage discharge systems, and shall be equipped with appropriate protective facilities;

d) There shall be an independent laboratory animal quarantine room, as well as facilities for the diagnosis, treatment, and prevention of laboratory animal diseases (where necessary);

e) Facilities shall be provided for the collection and disposal of animal excrement and other waste, and it shall be ensured that the safety and hygiene requirements are satisfied.

NOTE: the factors having an adverse effect on the validity of results include, but are not limited to microbial contamination, dust, electromagnetic interference, radiation, humidity, power supply, temperature, sound and vibration.

6.3.2 The laboratories shall document the requirements for facilities and environmental conditions necessary for conducting laboratory activities.

a) The laboratories shall be designed for effective operation, providing convenience and comfort to staff while minimizing the risk of injury and occupational disease.

b) Staff and visitors shall be protected from known or potential hazards. Necessary emergency first aid facilities and guidelines shall be provided.

6.3.3 When relevant specifications, methods, or procedures impose requirements on environmental conditions, or when environmental conditions affect the validity of results, the laboratories shall monitor, control and record environmental conditions. Special attention shall be paid to changes in cleanliness, temperature, humidity, noise and radiation (where necessary).

These parameters that need to be monitored and control ranges shall be documented, so that relevant personnel can determine whether environmental conditions are out of control and how to handle them.

6.3.4 The laboratories shall implement, monitor and periodically review measures for controlling facilities. These measures shall include, but are not limited to.

a) Controls on access to and use of areas affecting laboratory activities;

b) Prevention of contamination, interference or adverse effects on laboratory activities;

c) Isolation of incompatible laboratory activity areas.

6.3.5 When the laboratories conduct laboratory activities in locations or facilities outside of permanent controls, they shall ensure that the requirements for facilities and environmental conditions outlined in this document are met.

6.4 Equipment

6.4.1 The laboratories shall have the necessary equipment to correctly conduct laboratory activities and affect the results, including but not limited to measuring instruments, software, measuring standards, standard samples/substances, reference data, reagents, consumables or auxiliary devices. Food toxicology laboratories may be equipped with pathological testing equipment and biochemical testing equipment, depending on the studies being conducted. Regarding laboratory animals, the following shall be observed.

a) Laboratory animals shall be housed, transported, observed, used, and handled under appropriate conditions. Animal experiments and handling shall comply with the requirements of GB/T 35892.

b) Newly acquired laboratory animals shall be quarantined, until their health status is evaluated. If abnormal mortality and morbidity occur in a batch of laboratory animals, that batch shall not be used for studies.

c) In vitro cultured cells and bacteria shall be cultured, preserved, and transported under appropriate conditions to ensure the normal growth and reproduction of cell and bacterial test systems. […]