Article 1 Enterprises operating refrigerators or frozen drugs shall, in accordance with the requirements of the "Good Manufacturing Practices" (hereinafter referred to as the "Specifications"), in the process of receiving, accepting, storing, maintaining, discharging, transporting, etc., according to the pharmaceutical packaging. The marked storage requirements, using verified facilities, technical methods and operating procedures, real-time automatic monitoring and control of the temperature and humidity conditions during the storage of refrigerated and frozen drugs, and the temperature conditions during transportation to ensure the storage of drugs The temperature and humidity of the operating environment are controlled within the specified range.
Article 2 An enterprise shall, in accordance with the requirements of the “Regulationsâ€, be equipped with corresponding refrigeration and refrigeration storage and transportation facilities and automatic temperature and humidity monitoring systems, and maintain and manage the facilities and equipment.
(1) 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 standby generator set or a dual-loop power supply system.
(2) According to the business needs of the enterprise, reasonably divide the cold storage receipt and acceptance, storage, pre-cooling of packaging materials, packing and delivery, and drug storage to be treated, and clearly marked. Work activities such as acceptance, storage, zero-removal, refrigerated packaging, and delivery must be completed in the cold storage.
(3) The refrigerated truck has the function of automatically regulating the temperature, and its configuration complies with the relevant national standards; the refrigerated compartment has the functions of waterproofing, sealing, corrosion resistance, etc., and there is room for ensuring sufficient circulation of the airflow inside the compartment.
(4) The refrigerated box and the incubator have good thermal insulation performance; the refrigerated box has the function of automatically regulating the temperature, and the incubator is equipped with a cold storage agent and a device isolated from the medicine.
(5) Automatic monitoring system for temperature and humidity in cold storage, automatic temperature monitoring system for refrigerating truck, refrigerator and incubator, real-time collection, display and recording of temperature and humidity data, and remote and local real-time alarm function, which can be used by computer The recorded monitoring data is read and stored.
(6) Regularly inspect, maintain and record cold storage, refrigerated trucks, refrigerators and incubators.
Article 3 An enterprise shall verify the cold storage, refrigerated trucks, refrigerators, incubators, and the automatic monitoring system for temperature and humidity of refrigerated storage and transportation in accordance with the requirements of the Code and related appendices, and formulate the operation of facilities and equipment according to the parameters and conditions determined by verification. , the use of procedures.
Article 4 An enterprise shall, in accordance with the requirements of the “Regulationsâ€, conduct inspections on the receipt of refrigerated and frozen drugs.
(1) Check whether the refrigerated trucks or refrigerators and incubators that transport medicines meet the requirements, and those that fail to transport according to regulations shall be rejected.
(2) Check the temperature data of the refrigerated truck or the refrigerated box and the incubator when it arrives, export, save and check the temperature record of the transportation process, and confirm whether the temperature condition of the whole process of transportation meets the requirements.
(3) If the drug meets the requirements, the drug shall be placed in the area to be tested that meets the temperature requirements for inspection; if it does not meet the requirements, it shall be rejected, and the drug shall be stored in an environment that meets the temperature requirements and reported to the quality management department for disposal.
(4) Make a record of the receipt of goods, including: name, quantity, production enterprise, delivery unit, transportation unit, shipping location, departure time, transportation means, arrival time, arrival temperature, and receiving personnel Wait.
(5) Check the return of the drug after the sale, and check the temperature control document provided by the returning party and the relevant data of the temperature control during the sale. If the documents, data, or temperature control are not in compliance with the regulations, they shall be rejected, and the records shall be recorded and reported to the quality management department for processing.
Article 5 During storage and transportation, the stacking of refrigerated and frozen drugs shall meet the following requirements:
(1) The stacking distance of medicines in the cold storage, the distance between the medicine and the ground, the wall and the top of the warehouse meet the requirements of the "Specifications"; within 100 cm of the outlet of the refrigeration unit in the cold storage, and the position above the outlet of the cooling fan, Code discharge medicine;
(2) In the refrigerated compartment, the distance between the medicine and the front panel of the compartment is not less than 10 cm, and the distance between the rear panel, the side panel and the bottom panel is not less than 5 cm, and the height of the medicine stacking height shall not exceed the lower edge of the air outlet of the refrigeration unit to ensure normal circulation of the airflow and The temperature is evenly distributed.
Article 6 An enterprise shall be responsible for carrying out key maintenance inspections of refrigerated and frozen medicines stored in the warehouse.
When the temperature and humidity of the drug storage environment exceeds the specified range, effective measures shall be taken in time to prevent and control the excessive temperature and humidity on the quality of the drug.
Article 7 Enterprises transporting refrigerated and frozen drugs shall select appropriate means of transportation and temperature control according to the quantity of drugs, transportation distance, transportation time, temperature requirements, external environmental temperature, etc., to ensure that the temperature control during transportation meets the requirements.
During the transportation of refrigerated and frozen drugs, the temperature data in the refrigerated truck, refrigerator or incubator should be collected, recorded and uploaded in real time. When the temperature in the transportation process exceeds the specified range, the temperature and humidity monitoring system shall issue an alarm command in real time, and the relevant personnel shall find out the cause and take effective measures to control it in time.
Article 8 The use of refrigerators and incubators to transport refrigerated medicines shall be carried out in accordance with validated standard operating procedures for the packaging and packing of medicines.
(1) Pre-heat or pre-cool the refrigerator and incubator to the temperature range marked by the pharmaceutical packaging before packing.
(2) According to the conditions determined by the verification, the cold storage agent suitable for temperature control and transportation time limit is reasonably arranged in the incubator.
(3) The heat insulation device is used to isolate the medicine from the low temperature coolant.
(4) After the drug is packed, the refrigerated box starts the refrigerating power supply and temperature monitoring equipment, and the incubator starts the temperature monitoring equipment. After the temperature in the box starts to be monitored and recorded in real time, the box is sealed.
Article 9 The use of refrigerated trucks to transport refrigerated or frozen drugs shall be carried out in accordance with validated standard operating procedures prior to shipment.
(1) Open the refrigeration unit and temperature monitoring equipment in advance, preheat or pre-cool the interior of the vehicle to the specified temperature.
(2) Turn off the refrigeration unit when loading the truck and complete the drug loading as soon as possible.
(3) After the drug loading is completed, close the compartment door in time, check the sealing condition of the door and lock it.
(4) Start and check the operation status of the refrigeration unit and the temperature monitoring system, and the equipment can be operated normally.
Article 10 An enterprise shall formulate an emergency plan for temperature control during the storage and transportation of refrigerated and frozen drugs, and shall take effective measures to prevent accidents or emergencies such as abnormal weather, equipment failures, traffic accidents, etc. during transportation. The temperature caused by the abnormal situation is out of control.
Article 11 The emergency plan formulated by the enterprise shall include emergency organization, personnel responsibilities, facilities and equipment, external collaborative resources, emergency measures, etc., and shall be continuously improved and optimized.
Article 12: Personnel engaged in the work of receiving, accepting, storing, maintaining, leaving the warehouse, transporting and distributing goods such as refrigerated and frozen drugs shall be trained in relevant laws and regulations, professional knowledge, relevant systems and standard operating procedures. After that, you can get on the job.
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