XCMG Chu Sheng - Refrigerated, Frozen Storage of Drugs and Refrigerated Transportation Management of Pharmaceuticals

Article 1 When an enterprise operates cold-stored or frozen pharmaceuticals, it shall, in accordance with the requirements of the "Standards for the Administration of Pharmaceutical Business Quality Management" (hereinafter referred to as "the Code"), receive, carry, check, store, maintain, export, and transport, according to the pharmaceutical packaging. The marked storage requirements, using validated equipment, technical methods and operating procedures, provide real-time automatic monitoring and control of the temperature and humidity conditions during the storage of refrigerated and frozen pharmaceuticals, and the temperature conditions during transportation, ensuring the storage of drugs. Transportation environment temperature and humidity control within the specified range.
Article 2 An enterprise shall, in accordance with the requirements of the "Code," be equipped with appropriate refrigeration and freezing storage and transportation facilities, equipment and automatic temperature and humidity monitoring systems, and maintain and manage facilities and equipment.

(a) The cold storage design meets the requirements of relevant national standards; the cold storage has the function of automatically regulating temperature and humidity, and has a backup generator set or dual-circuit power supply system.

(2) According to the needs of the company's operation, it is necessary to rationally divide the acceptance of cold storage, storage, pre-cooling of packaging materials, packing and shipping, and storage of pending drugs, etc., and clearly indicate them. Acceptance, storage, unpacking, refrigerated packaging, delivery, and other operations must be completed in a cold room.

(3) The refrigerated truck has the function of automatically adjusting the temperature. The configuration of the refrigerated truck meets the requirements of the relevant national standards; the refrigerated carriage has the properties of waterproof, airtight, corrosion-resistant, etc. The interior of the compartment has space for sufficient circulation of the air flow.

(D) The refrigerator and the incubator have good heat preservation performance; the refrigerator has the function of automatic temperature control, and the incubator is equipped with a cooling agent and a device that is isolated from the medicine.

(5) Automatic temperature and humidity monitoring system for cold storage, automatic temperature monitoring system for refrigerated trucks, refrigerators, and incubators, which can collect, display, and record temperature and humidity data in real time, and have remote and on-site real-time alarm functions. Read and store the recorded monitoring data.

(6) Regular inspections, maintenance, and records of cold storage, refrigerated trucks, and refrigerators and incubators.
Article 3 An enterprise shall verify cold storage, refrigerated trucks, refrigerators, incubators, and automatic monitoring systems for temperature, humidity, and humidity of refrigerated storage and transportation in accordance with the requirements of the “Regulations” and relevant appendices, and formulate the operation of facilities and equipment based on the parameters and conditions determined by verification. Use procedures.
Article 4 An enterprise shall, in accordance with the requirements of the "Regulations," carry out inspections on the receipt of frozen and frozen drugs.

(1) Whether the refrigerated trucks, refrigerators, and incubators for transporting drugs are inspected in accordance with the regulations, and those that fail to comply with regulations shall be rejected.

(2) Check the temperature data of the refrigerated truck or the refrigerator and the incubator upon arrival, export, save and check the temperature record of the transportation process, and confirm whether the temperature status of the entire transportation process complies with the regulations.

(3) In compliance with the regulations, the drug shall be placed in the area subject to the temperature test for inspection; if it does not meet the requirements, it shall be rejected, the drug shall be stored in isolation in an environment meeting the temperature requirements, and reported to the quality control department.

(4) Make a record of the receipt of goods, including: drug name, quantity, production company, delivery unit, transportation unit, place of shipment, departure time, means of transport, arrival time, arrival temperature, recipient Wait.

(5) Check the temperature control documentation provided by the returning party and the data related to the temperature control during the sale of the medicines that have been returned. If documents or data cannot be provided, or if the temperature control does not meet the requirements, it shall be rejected and records shall be made and reported to the quality management department.
Article 5 In the process of storage and transportation, the storage of refrigerated and frozen drugs shall meet the following requirements:

(1) The stacking distance of medicines in cold storage, the distance between medicines and the ground, walls, and the top of the warehouse meets the requirements of the "Code"; within 100 cm of the air outlet of refrigeration units in cold storage, and higher than the position of the air outlets of chillers, no Code drug;

(2) Within the refrigerated compartment, the distance between the medicine and the front panel shall not be less than 10 centimeters, and the distance between the rear panel, the side panel and the bottom panel shall not be less than 5 centimeters. The height of the medicine stacking shall not exceed the lower edge of the air outlet of the refrigeration unit to ensure the normal circulation of air flow and The temperature is evenly distributed.
Article 6 An enterprise shall be responsible for the key maintenance and inspection of refrigerated and frozen drugs stored in the warehouse by special personnel.

When the temperature and humidity of the drug storage environment exceeds the prescribed range, effective measures shall be taken to control it in a timely manner so as to prevent the influence of excessive temperature and humidity on the quality of the drug.
Article 7 Enterprises transporting frozen and frozen drugs shall select appropriate transportation tools and temperature control methods according to the quantity of drugs, transportation distance, transportation time, temperature requirements, and external environmental temperature, so as to ensure that the temperature control in the transportation process meets the requirements.

During the transportation of refrigerated and frozen drugs, the temperature data in the refrigerated truck, refrigerator or incubator shall be collected, recorded and uploaded in real time. When the temperature exceeds the specified range during transportation, the temperature and humidity monitoring system shall issue an alarm instruction in real time. The relevant personnel shall identify the cause and take effective measures to control it in time.
Article 8 The use of refrigerators and incubators for the transport of refrigerated drugs shall be carried out in accordance with validated standard operating procedures for the packaging and packing of drugs.

(1) Preheating or precooling the refrigerator and incubator to the temperature range that meets the labeling of the pharmaceutical packaging before packing.

(2) According to the conditions determined by the verification, a cooling agent suitable for the temperature control and the time limit for transportation shall be properly arranged in the incubator.

(c) Insulation boxes use insulated devices to isolate drugs from cryogenic storage.

(D) After the medicine is packaged, the refrigerator starts the refrigerating power supply and the temperature monitoring equipment. The incubator starts the temperature monitoring equipment. After the temperature in the box is monitored and recorded in real time, the box is sealed.
Article 9 The use of refrigerated trucks for transporting refrigerated or frozen drugs shall be carried out in accordance with a validated standard operating procedure prior to shipment.

(1) Opening the refrigeration unit and temperature monitoring equipment in advance, preheating or precooling the cabin to the specified temperature.

(2) Close the refrigeration unit when loading the vehicle and complete the drug loading as soon as possible.

(3) When the medicines are loaded, close the doors of the carriages in time, check the closed conditions of the doors, and lock them.

(D) start and check the refrigeration unit, temperature monitoring system operating conditions, the equipment can only operate normally shipped.
Article 10 An enterprise shall formulate an emergency plan for temperature control during the storage and transportation of refrigerated and frozen medicines, and take timely and effective countermeasures against accidents or emergencies such as abnormal weather, equipment failures, traffic accidents, etc. during transportation. The temperature caused by abnormal conditions is out of control.

Article 11 The emergency plan prepared by the enterprise shall include the contents of the emergency organization, personnel responsibilities, facilities and equipment, external cooperation resources, and emergency measures, and shall be continuously improved and optimized.
Article 12 Personnel engaged in the work of receiving, inspection, storage, maintenance, delivery, transportation and distribution of refrigerated and frozen drugs shall receive training in relevant laws and regulations, professional knowledge, relevant systems, and standard operating procedures. After the job can be done.

[Company Name]: Xiagong Chusheng (Hubei) Special Automobile Manufacturing Co., Ltd.
[Corporate address]: Chusheng Industrial Park, Xiagong Workers, No.9 Jiliang Avenue, Suizhou City, Hubei Province
[fixed telephone]: 0722-7607222
[Mobile Wechat]: 138 7288 0668
[Contact QQ]: 815329901
[Corporate website]: