Article No.? The content of the article? The main points of the inspection? Results
*1.1?Cold chain medical device wholesalers (hereinafter referred to as "wholesalers") shall, according to the scale of operation and varieties, be equipped with appropriate facilities and equipment such as cold storage (refrigerator or freezer), refrigerated trucks, refrigerated containers, heat preservation tanks, etc. The cold storage and transportation management of medical devices shall be carried out by the wholesalers in accordance with the requirements of the relevant regulations.
Retailers of cold chain medical devices (hereinafter referred to as "retailers") should be equipped with appropriate refrigeration equipment (such as freezers, refrigerators, etc.) according to the scale and variety of business. In the refrigeration equipment, at least one measuring point terminal should be placed to monitor and record its temperature. ?1. Check the availability of relevant facilities and equipment in wholesale enterprises;
2. Check the availability of relevant facilities and equipment in retail enterprises.
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*1.2?The cold storage shall have the function of automatic temperature regulation and control, and need to be equipped with two sets of independent refrigeration units, and the refrigeration capacity of each set of units shall be compatible with the volume of the cold storage. In order to ensure the continuous power supply of the refrigeration system, the enterprise should be equipped with a backup generator set or double circuit power supply system.
Wholesale enterprise cold storage library should be reasonably divided into the inspection area, qualified products area, shipping area, non-qualified products area, packaging materials pre-cooling area (cargo space), and so on, and has a clear labeling. 1. Check the relevant functions of the cold storage;2. Check the availability of the relevant equipment;
3. Check the operation of the relevant equipment;
4. Check the zoning and labeling of the cold storage library.
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*1.3?Refrigerated trucks and heat preservation trucks should be equipped with the function of automatic temperature control, and the compartments should be waterproof and airtight,? The interior of the compartment should have space to ensure adequate circulation of airflow. 1. Check the relevant functions of the vehicle.
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Clause number ? Clause content ? Inspection points? Result Determination
*1.4?Refrigerator and heat preservation box have good heat preservation function, and should be in line with the relevant standards and product storage and transportation requirements. 1.Check the documents proving the heat preservation function of refrigerator and heat preservation box (verification report, manual, etc.);
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*1.5?Cold storage, refrigerated trucks, insulated trucks shall be equipped with automatic temperature monitoring system (hereinafter referred to as "system"). Cold storage tanks, heat preservation tanks or other refrigeration equipment shall be equipped with instruments and equipment for automatic temperature recording and storage.
1. The system can automatically monitor the temperature, display, record and alarm, can ensure the continuity of the record and the timeliness of the alarm.
2. The system shall automatically uninterruptedly monitor and record the temperature environment in the process of storage and transportation of cold chain medical devices, and update the temperature data of the measurement point at least once every 1 minute; automatically record the real-time temperature data at least once every 30 minutes in the process of storage of medical devices; automatically record the real-time temperature data at least once every 5 minutes in the process of transportation; and when the monitored temperature value exceeds the specified range, the system shall automatically record the real-time temperature data at least once every 5 minutes. When the monitoring temperature value exceeds the specified range, the system should record real-time temperature data at least every 2 minutes.
3. When the temperature value monitored by the system reaches the set threshold or exceeds the specified range, the system should be able to realize sound and light alarm, and at the same time, use SMS communication to send out alarm information to at least 3 designated personnel.
4. Cold storage, refrigerated trucks, insulated trucks installed the number and location of measurement point terminal should meet the following requirements:
Each independent cold storage, should be installed at least 2 or more measurement point terminal; each independent refrigerated trucks, insulated trucks, the number of installation of the measurement point terminal shall not be less than two.
5. The system measuring point terminals and temperature monitoring instruments and equipment should be calibrated at least once a year; the system equipment should be regularly inspected, repaired and maintained, and archives should be established. ?1. Check the relevant functions of the system, facilities and equipment;
2. Check the configuration of the relevant facilities and equipment;
3.
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Clause No. ? Clause content ? Inspection points? Result Determination
*2.1?Cold storage, refrigerated trucks, insulated trucks, refrigerated containers, insulated containers, as well as systems shall be validated prior to use, periodically validated, and validated in the event that the time of deactivation exceeds the specified time limit. Facilities and equipment without validation shall not be applied to the storage and transportation process of cold chain medical devices. ? 1. Check the validation report of the relevant facilities and equipment.
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2.2?Validation control documents shall be established and formed, and the contents of the documents include validation program, standards, reports, evaluation, deviation handling and preventive measures. ?1.View the validation control document.
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2.3?The appropriate duration of continuous validation should be determined according to the validation object to ensure that the validation data are sufficient, valid and continuous. ?1. Check the content of the validation report (should be determined according to the length of time the enterprise operates the product transportation of continuous validation time).
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*2.4?The temperature sensor used for validation should be calibrated by a statutory metrological institution, and the calibration certificate (copy) should be used as a necessary attachment to the validation report, and the validation data should be true, complete, valid and traceable. ?1. Check the calibration certificate of the relevant equipment (calibration certificate should be within the validity period).
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2.5?Relevant facilities and equipment shall be used correctly and reasonably according to the parameters and conditions determined by the verification. ?1. Check the parameter settings of the relevant facilities and equipment.
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Clause No. ? Clause content ? Inspection points? Result Determination
3.1?Wholesale and retail enterprises shall verify the mode of transportation, arrival and in-transit temperature, departure time and arrival time and make records when receiving cold-chain medical devices; cold-chain medical devices returned after sale shall also be verified during the period of sale of temperature records. If it meets the requirements, it should be moved into the cold storage area in time; if it does not meet the temperature requirements, it should be rejected. 1. Check the receipt management regulations and related records;
2. Check the return management regulations and related records;
3. Confirm the compliance of the operation through the actual operation of the relevant personnel.
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*4.1?Wholesale enterprises shall conduct acceptance of cold chain medical devices in cold storage. Acceptance inspection personnel should focus on checking the product status, and make acceptance records in accordance with the requirements of the "Code for Quality Management of Medical Device Business". ?1. Check the acceptance management regulations and related records;
2. Confirm the compliance of the operation through the actual operation of the acceptance personnel;
3. Check the division of the cold storage area.
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5.1?Wholesale and retail enterprises shall store and inspect the cold chain medical devices in accordance with the requirements of the instructions or labels of the medical devices after acceptance into the warehouse, and shall focus on inspecting and documenting the packaging, labeling, appearance, and temperature conditions of the stored cold chain medical devices.
No items shall be yarded within 100 centimeters of the air outlet of the refrigeration unit in the cold storage as well as the position higher than the air outlet of the chiller. 1. Check the storage and inspection management regulations and related regulations;
2. Confirm the operational compliance through the actual operation of the relevant personnel;
3. Check the product coding in the cold storage.
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6.1?When the wholesale enterprise cold chain medical devices out of the warehouse, a person should be responsible for the cold chain medical devices out of the warehouse to review, packing and sealing boxes, loading and yardage work. ?1. Check the job setup and job responsibilities.
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Clause No. ? Clause content ? Inspection points? Result Determination
6.2?Wholesalers shall, according to the parameters and conditions determined by the validation and in accordance with the standard operating procedures for the packaging of cold-chain medical devices, correctly and reasonably use the refrigerator and insulated box, and the operation of packing and sealing of cold-chain medical devices shall comply with the following requirements:
1.Preheat or pre-cool the refrigerator or insulated box before packing to the temperature in line with the instructions for the medical device or the label indication range.
2. In accordance with the conclusions determined by the validation, the insulation box is reasonably equipped with temperature control and transportation time limit appropriate cold storage agent.
3. The refrigerated box starts the power supply and temperature monitoring equipment (the insulated box starts the temperature monitoring equipment), and after checking that the equipment operates normally, the products are packed in boxes.
4. The products should be packed with temperature isolation device to isolate the medical equipment from the refrigerant and other refrigerants.
5. The packing and sealing of cold chain products should be done in a refrigerated environment. ? 1. Check the relevant facilities and equipment to verify the control documents;
2. Check the relevant facilities and equipment operating procedures;
3. Confirm their operational compliance through the actual operation of the relevant personnel.
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6.3?Wholesale companies should check and record the temperature of refrigerated trucks, insulated trucks, refrigerated containers, and insulated containers when they are shipped. ?1. Check the outgoing management regulations and shipment records;
2. Confirm their operational compliance through actual operation by relevant personnel.
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*7.1?Wholesale enterprises shall select appropriate transportation means and temperature control methods according to the quantity of cold-chain medical devices, transportation distance, transportation time, temperature requirements, and external ambient temperature to ensure that the temperature control during transportation meets the requirements. When the temperature during the transportation of cold chain medical devices exceeds the specified range, an alarm command should be issued, and the relevant personnel should find out the reason and take effective measures to regulate in time. ? 1. Check the conformity of the actual business operations and validation report (whether with the validation report to determine the means of transportation and temperature control methods consistent);
2. Check the temperature records in transit, alarm records and records of treatment measures.
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Clause No. ? Clause content ? Inspection points? Result Determination
7.2?If refrigerated trucks or insulated trucks are used to transport cold-chain medical devices, the following requirements shall be met before shipment:
1.Turn on the temperature control and monitoring equipment in advance, and preheat or pre-cool the compartments to the specified temperature.
2. Turn off the temperature control equipment when loading begins and complete loading of medical devices as soon as possible.
3. Refrigerated compartments of medical equipment, and the distance between the front panel of the compartment is not less than 10 centimeters, and the back panel, side panels, the spacing between the floor is not less than 5 centimeters, the height of the yard shall not exceed the refrigeration unit outlet along the lower edge of the air to ensure that the airflow is normal circulation and uniform distribution of temperature.
4. After loading the cold chain equipment, close the door of the compartment in time, check the closure of the door and lock it.
5. Start the temperature control equipment, check the operation of temperature control and monitoring equipment, and start transportation only after normal operation. 1. Check the relevant facilities and equipment to verify the control documents;
2. Check the relevant facilities and equipment operating procedures;
3. Confirm their operational compliance through the actual operation of the relevant personnel.
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8.1?Retail and wholesale enterprises shall formulate emergency plans for temperature control of cold chain medical devices during storage and transportation, and be able to take timely and effective countermeasures against accidents or emergencies, such as power outages, abnormal climates, equipment malfunctions and traffic accidents, that occur in the process of storage and transportation, so as to prevent the temperature from going out of control due to the abnormal conditions. ? 1. Check the product storage and transportation temperature control emergency plan.
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9.1?Personnel engaged in the positions of receiving, acceptance, storage, inspection, warehousing and transportation of cold-chain medical devices shall be trained in relevant laws and regulations, professional knowledge, relevant systems and standard operating procedures, and shall only be allowed to take up their duties after passing the examination.
1. Check the enterprise personnel roster;
2. Check the training and assessment records of relevant personnel.
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Clause No. ? Clause content ? Inspection points? Result Determination
*10.1?When the wholesale enterprise commissions other units to transport medical devices in cold chain, it shall meet the following requirements:
(a) Requesting the carrier's transportation qualification documents, proof of transportation facilities and equipment and monitoring system and verification documents, qualification certificates of the carrier's personnel, and relevant information such as temperature control and monitoring of the transportation process.
(2) The carrier's transportation facilities and equipment, personnel qualifications, quality assurance capabilities, safe transportation capabilities, risk control capabilities, etc. for pre-commissioning and periodic audits, and the audit report is archived for reference.
(3) The carrier's cold chain transportation facilities and equipment and automatic monitoring system shall comply with the regulations and be verified.
(4) The content of the entrusted transportation agreement shall include: the development and implementation of transport standard operating procedures in accordance with the requirements of the carrier, the requirements of temperature control and real-time monitoring in the transportation process, the requirements of the time limit in transit, and the responsibility for quality and safety in the transportation process.
(e) If necessary, according to the qualifications and conditions of the carrier, the carrier's relevant personnel to review and assess. ? 1. Check the commissioned transportation units, facilities and equipment and related personnel qualification documents;
2. Check the commissioned carrier quality assurance capabilities of the assessment, evaluation records;
3. Check the commissioned transportation agreement;
4. Check the commissioned transportation records.
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