The temperature of the drug cold storage is between+2 ℃ and+8 ℃cold storageThe drug cold storage (drug cool storage) mainly stores pharmaceutical products that cannot be stored at room temperature. Storing them in a low-temperature environment can ensure that the drugs do not deteriorate or become ineffective, and extend the shelf life of the drugs. Drug cold storage (cool storage for drugs) generally requires GMP certification.

Management system for drugs in drug cold storage

1、 Purpose:

Standardize the cold chain storage and transportation management of drugs to ensure their effectiveness and safety.

2、 Scope of application:

Used for drugs with special temperature requirements during storage and transportation (cold chain drugs).

3、 Related Responsibilities:

Cold storage administrators, cold chain transport personnel, etc

4、 Basis for formulation:

According to the Drug Administration Law and the Good Manufacturing Practice for Drugs

5、 Institutional content:

1. Cold chain drug description

1.1 Refrigerated drugs refer to drugs that require temperature requirements such as refrigeration and freezing during storage and transportation.

1.2 Refrigeration refers to storage and transportation conditions where the temperature meets the range of 2 ℃ to 8 ℃.

1.3 Freezing refers to storage and transportation conditions where the temperature meets or falls below -2 ℃.

1.4 Cold chain refers to a special supply chain management system that ensures the quality of temperature sensitive drugs such as refrigerated drugs. The entire storage and circulation process from the finished product warehouse of the production enterprise to before use must be in a specified temperature environment.

The temperature control system includes an active temperature control system and a passive temperature control system. Active temperature control system refers to facilities and equipment equipped with mechanical and electrical instrument components to control temperature, and regulate and control the storage and transportation temperature of drugs within a set range through program operation. Passive temperature control system refers to equipment that controls temperature through non electromechanical methods, such as insulation boxes.

2. Personnel training management

2.1 The operators involved in the receipt, acceptance, storage, maintenance, packaging, shipping, and use of refrigerated drugs should receive training from the company's quality management department and storage and transportation department, and be familiar with cold chain management content such as basic knowledge of cold chain, temperature and humidity sensitivity characteristics of the refrigerated drugs they operate, and product distribution characteristics.

Personnel involved in the operation, use, and maintenance of the insulation box must receive training on the operating procedures and pre cooling conditions of the cold storage agent from the company's quality management department.

2.3 The use of computer systems and temperature and humidity recorders involved in cold chain management should be equipped with education or relevant qualifications that meet the prescribed requirements, and dedicated personnel should be appointed to provide relevant operational training.

2.4 Personnel engaged in the receiving, inspection, storage, maintenance, shipping, and transportation of refrigerated drugs must receive training on the storage, transportation, and emergency response of refrigerated drugs before they can take up their posts.

2.5 The Quality Management Department shall establish training plans for operators and management personnel, conduct regular training, and evaluate the effectiveness of the training.

3. Management of refrigerated drug receipt and acceptance

3.1 The receiving, shipping, and loading area for refrigerated drugs should be located in the designated area of the company and meet the temperature requirements of 2-8 degrees Celsius. It should not be placed in direct sunlight, near heat source equipment, or other locations that may raise the ambient temperature.

3.2 Real time temperature records during drug transportation should be checked upon receipt, and the temperature should be detected using an infrared temperature detector.

3.3 When receiving refrigerated drugs, a transportation handover form should be requested, real-time temperature records should be kept, and signed or stamped for confirmation. There are multiple handover stages, and each handover stage requires a signed handover receipt.

3.4 The time for transferring refrigerated drugs from the receiving area to the testing area that meets the temperature requirements should be within 10 minutes for refrigerated drugs and within 5 minutes for frozen drugs.

3.5 Acceptance should be conducted in a refrigerated environment, and drugs that pass the acceptance should be quickly transferred to the storage environment specified in the drug instructions.

3.6 For returned drugs, the recipient should treat them as received and strictly follow the procedures of 3.1, 3.2, 3.3, 3.4, and 3.5, and keep records. If necessary, they should be sent to the inspection department for inspection.

3.7 The records of receipt, shipment, and acceptance of refrigerated drugs should be kept for at least 5 years.

4. Storage and maintenance management of refrigerated drugs

4.1 The temperature for storing refrigerated drugs should comply with the storage temperature requirements specified in the refrigerated drug instructions.

4.2 When storing refrigerated drugs, they should be classified and stacked according to the variety and batch number of the refrigerated drugs. There should be a certain distance left for drug stacking. The distance between drugs and walls, roofs (beams) shall not be less than 30 centimeters, the distance between drugs and internal temperature control equipment in the warehouse shall not be less than 30 centimeters, and the distance between drugs and the ground shall not be less than 10 centimeters.

4.3 Refrigerated drugs should be inspected and recorded for in warehouse maintenance in accordance with the "Good Manufacturing Practice for Drugs". If any quality abnormalities are found, isolation should be carried out first, shipment should be suspended, records should be kept, and the goods should be promptly sent to the inspection department for inspection and handled according to the inspection results.

4.4 Maintenance records should be kept for at least 5 years.

5. Management of refrigerated drug delivery

5.1 Refrigerated drugs should designate personnel responsible for the shipment, consolidation, and loading of refrigerated drugs, and select suitable transportation methods.

5.2 The unpacking of LCL should be carried out in an environment with a storage temperature of 2-8 degrees Celsius as specified for refrigerated drugs.

When loading refrigerated drugs, the refrigerated truck or insulated box should be pre cooled to meet the storage and transportation temperature of the drugs.

5.4 The time for transferring refrigerated drugs from the storage area to transportation equipment that meets delivery requirements should be within 10 minutes for refrigerated drugs and within 5 minutes for frozen drugs.

6. Management of refrigerated drug transportation

6.1 Facilities, equipment, and transportation vehicles should be equipped to ensure the temperature requirements for refrigerated drugs.

6.2 When transporting refrigerated drugs in insulated boxes, special precautions such as storage conditions, departure time, and insulation time limit should be clearly indicated on the handover form with the person in charge, and signed or stamped.

6.3 When transporting refrigerated drugs using refrigerated trucks, the drugs should be loaded according to the operating procedures of the refrigerated truck and safely delivered.

6.4 The company shall establish a refrigerated drug transportation procedure. The transportation procedure includes pre shipment notification, shipping method, route, contact person, temperature record on the shipping map, and abnormal handling plan.

6.5 Transport personnel should inspect the insulation boxes, refrigerated trucks, related refrigeration equipment, and temperature and humidity recorders before traveling to ensure that all facilities and equipment are normal and meet temperature requirements. During transportation, it is necessary to check the temperature recording display device in a timely manner. If there is any abnormal temperature situation, it should be reported to the quality management department in a timely manner and relevant measures should be taken.

When using insulated boxes for transportation, at least one temperature and humidity recorder should be shipped with the goods, and at least one temperature recorder should be placed in each specification of refrigerated container for shipment. The temperature recorder should be placed in a representative location specified in the verification report.

6.7 Refrigerated drugs should not be placed in direct contact with the cooling medium. The drugs should be isolated from the cooling medium to prevent any impact on the quality of the drugs.

7. Temperature control and monitoring management of refrigerated drugs

7.1 Refrigerated drugs should undergo 24-hour continuous and automatic temperature and humidity recording and monitoring. The recording interval should not exceed 30 minutes per time in the warehouse, and should not exceed 5 minutes per time during transportation.

7.2 Cold storage should undergo regular verification according to the company's verification management system to ensure compliance with drug refrigeration requirements.

7.3 The temperature monitoring data of the automatic temperature recording device can be read, archived, and backed up, with records kept for at least 3 years.

7.4 The temperature alarm device should be able to sound an alarm in a critical state, and a dedicated person should handle it in a timely manner. Emergency handling of temperature and humidity exceeding alarm situations should be done and recorded.

7.5 Start stop temperature setting for refrigeration equipment: Refrigeration should be between 3 ℃ and 7 ℃, and freezing should be below -3 ℃.

During transportation, refrigerated trucks should use automatic monitoring, automatic regulation, automatic recording, and alarm devices to monitor and record temperature and humidity in real time. The recording time interval should not exceed 5 minutes, and the data can be read. The detailed temperature record should be handed over to the receiving party along with the drug.

7.7 When using insulated boxes for transportation, according to the performance verification results of the insulated boxes, they should be delivered within the insulation time supported by the insulated boxes and meeting the storage conditions of the drugs.

7.8 Automatic temperature and humidity recorders and other equipment should be calibrated according to regulations to maintain accurate and intact data.

8 Other management

8.1 Cold chain equipment should establish equipment files and lists, detailing equipment names, manufacturers, purchase dates, usage conditions, equipment sources, equipment custodians, maintenance service providers, etc., and long-term storage of equipment user manuals.