The following is the original regulation issued by the State Food and Drug Administration on the administration of frozen drugs:
Original title "Storage and Transportation Management of Refrigerated and Frozen Drugs" (No. 38, 2013 of the State Food and Drug Administration, date of issue: October 23, 2013)
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 storage and transportation facilities of refrigerated and frozen drugs, which can collect, display, record, and transmit temperature and humidity data during storage and temperature data during transportation, and have remote and local data in real time. Real-time alarm function can read and store the recorded monitoring data by computer.
(6) Regular inspections, maintenance, and records of cold storage, refrigerated trucks, and refrigerators and incubators.
Article 3 An enterprise shall verify the cold storage, refrigerated trucks, refrigerators, incubators, and automatic temperature and humidity monitoring systems in accordance with the requirements of the â€œRegulationsâ€ and relevant appendices, and formulate the operation of the facilities and equipment according to 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.
(D) receipt must be well documented, including: drug name, quantity, production companies, delivery units, transport units, shipping locations, departure time, means of transport, arrival time, arrival temperature, receiving personnel.
(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 drugs.
(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 When an enterprise transports cold-stored or frozen drugs, it shall select appropriate transportation tools and temperature control methods according to the quantity of drugs, transportation distance, transportation time, temperature requirements, external environment temperature, etc. to ensure that the temperature control in the transportation process meets the requirements.
In the process of transporting cold and frozen drugs, temperature data in refrigerated trucks, refrigerators, or incubators should be collected, recorded, and transmitted in real time. When the temperature during transportation exceeds the specified range, the automatic 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 transporting refrigerated drugs shall follow the validated standard operating procedures for the operations of packaging and packing 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 equipped in the incubator.
(c) Insulation boxes use insulated devices to isolate drugs from cryogenic storage.
(D) After the medicines are packed, the refrigerator starts the power supply and temperature monitoring equipment, and the incubator starts the temperature monitoring equipment. After the inspection equipment runs normally, the box is closed.
Article 9 The use of a refrigerated truck for transporting refrigerated or frozen drugs shall be carried out in accordance with a validated standard operating procedure prior to shipment.
(1) Opening the temperature control and monitoring equipment in advance, preheating or precooling the cabin to a prescribed temperature.
(2) Turn off the temperature control equipment 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 temperature control equipment, check the temperature control and monitoring equipment operating conditions, normal operation before shipment.
Article 10 An enterprise shall formulate an emergency plan for temperature control during the transport of refrigerated and frozen medicines. It shall be able to take timely and effective countermeasures against accidents or emergencies such as abnormal weather, equipment failures, traffic accidents, etc. during transportation to prevent abnormalities. The temperature caused by the situation is out of control.
Article 11 The emergency plan prepared by the company shall include the contents of the emergency organization, personnel responsibilities, facilities and equipment, external cooperation resources, emergency measures, etc., and shall be constantly improved and optimized.
Article 12 Personnel engaged in the work of receipt, acceptance, storage, maintenance, delivery, and transportation of refrigerated and frozen drugs shall receive training in relevant laws and regulations, professional knowledge, relevant systems, and standard operating procedures. After passing the examination, Before you can get a job.
Article 13 When an enterprise entrusts other units to transport frozen or frozen drugs, it shall ensure that the entrusted transportation process complies with the relevant provisions of the "Regulations" and this Appendix.
(1) Ask the carrier's transportation qualification documents, transportation facilities and equipment, monitoring system certification and verification documents, qualification certificates of the carrier, temperature control and monitoring of the transportation process, and other relevant documents.
(2) Pre-delegation and regular audits of the carrierâ€™s transportation facilities, equipment qualifications, personnel qualifications, quality assurance capabilities, safe transportation capabilities, risk control capabilities, etc., and audit reports are filed for future reference.
(3) The carrier's cold storage and refrigerated transport facilities, equipment, and automatic monitoring systems that do not meet the requirements or have not been verified shall not be commissioned for transportation.
(4) Signing a commissioned transportation agreement with the carrier, which includes the carrier's formulation and implementation of the transportation standard operating procedures that meet the requirements, the requirements for temperature control and real-time monitoring in the transportation process, and the responsibilities for quality and safety in transit time limits and during transportation.
(5) According to the qualifications and conditions of the carrier, the relevant personnel of the carrier shall be trained and assessed if necessary.
A refrigerated truck is a closed box transporter for transporting frozen or fresh cargo, a refrigerated transport unit equipped with a refrigeration unit and a refrigerated transport vehicle for polyurethane insulation. It is commonly used for transporting frozen foods (refrigerated vehicles) and dairy products. (milk transport vehicles), fruits and vegetables (fresh goods vehicles), vaccine drugs (vaccine transport vehicles), etc.
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