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

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.

6.2 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;

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.

6.4 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.