In Vitro Diagnostic Reagents Logistics Quality Control

To ensure that in vitro diagnostic reagents meet the requirements in terms of circulation and other aspects and to ensure the quality of clinical reagents, requirements have been set for the receipt, acceptance, storage, inventory inspection, delivery, transportation, temperature monitoring and control, facilities and equipment, personnel and training, and after-sales service of IVD reagents in the logistics process. These requirements apply to logistics processes that use dedicated facilities and equipment to control the quality of IVD reagents during production, circulation, and use.

Scope of application of in vitro diagnostic reagents

This applies to the entire process from receipt of in vitro diagnostic reagents, which are stored at cold temperatures, or frozen, as required by the quality standards, and which must be maintained at a temperature between 2 and 10 degrees Celsius, to the signing of receipt by clinical departments, as well as certain individual varieties of in vitro diagnostic reagents, as required by the quality standards, that are stored frozen during transportation.

• Cold storage: refers to in vitro diagnostic reagents that require refrigeration or freezing during storage and transportation processes.

• Cold storage: refers to storage and transportation conditions in which the temperature is between 2 and 10 degrees Celsius.

• Freezing: refers to storage and transportation conditions in which the temperature is between -10 and 25 degrees Celsius.

• Cold chain logistics: refers to the logistics process for refrigerated IVD reagents. In order to protect the characteristics of ivd raw materials, the IVD reagents should be controlled within a specified temperature range throughout the logistics process from the finished product warehouse to the in vitro diagnostic reagent warehouse, using dedicated facilities and equipment provided by the manufacturer, operator, logistics company, and user.

• Cold chain transportation equipment includes refrigerated trucks and vehicle-mounted refrigerated containers and insulated boxes, with refrigerated trucks having the function of automatically controlling and displaying temperature, storing and retrieving temperature monitoring data.

Logistics distributor of in vitro diagnostic reagents

• According to the temperature control requirements during cold chain transportation and the scale of the business growth of the entrusting party, the logistics distributor should provide the necessary and sufficient cold chain facilities and equipment, with cold storage operators responsible for managing the receipt and delivery of refrigerated goods, managing the storage of refrigerated goods, and maintaining and repairing operational tools.

• The quality department of the logistics distributor should perform validation work on the cold storage, refrigerated trucks, vehicle-mounted refrigerated containers, insulated boxes, and other insulation packaging and transportation vehicles to ensure that the transportation temperature of ivd diagnostic reagent is within a reasonable range. The full-quality management department of the logistics distributor is responsible for developing a working manual for refrigerated goods, handling abnormal situations during the operation process, reading temperature records and evaluating temperature control situations.

• The operating department of the logistics distributor must operate according to the predetermined operating procedures and review the implementation of the standard for providing constant temperature transportation control of refrigerated goods.

• The transportation department of the logistics distributor must pay attention to the temperature control during transportation and conduct the handover in accordance with the requirements.

• If the logistics distributor entrusts the transportation to a carrier, the qualification and cold chain transportation capability of the carrier should be reviewed, the entrustment transportation agreement signed, and a regular on-site review system established. The first-time carrier should be validated and satisfy the usage requirements.

• The logistics distributor should develop a risk prevention program for temperature control during refrigerated and frozen storage and transportation of IVD reagents. In case of unexpected or emergency situations such as abnormal weather, equipment failure, and traffic accidents, effective risk control measures should be taken in a timely manner to prevent temperature control loss due to abnormal situations.

• The risk prevention program should include emergency organizational structures, personnel responsibilities, facilities and equipment, external collaboration resources, and emergency measures. The risk prevention program should be continuously improved and optimized based on national relevant laws, enterprise operating conditions, and changes in the external environment.