1. cold chain facilities and equipment requirements
1. article 49 of GSP stipulates that those who engage in cold storage and frozen drugs shall be equipped with the following facilities and equipment:
(1) cold storage suitable for their business scale and variety, and those who engage in vaccines shall be equipped with more than two independent cold storage;
(2) Equipment for automatic monitoring, display, recording, regulation and alarm of cold storage temperature;
(3) standby generator set or double-circuit power supply system of refrigeration equipment in cold storage;
(4) For drugs with special low temperature requirements, facilities and equipment that meet their storage requirements shall be provided;
(5) refrigerated trucks and equipment such as vehicle-mounted refrigerators or incubators.
2. Guangdong province's specific requirements for cold chain operation facilities and equipment are: to operate refrigerated varieties, enterprises must have cold storage, at least one refrigerated truck and at least five incubators. Cold storage generally requires more than 2 cubic meters, but it should meet the requirements of article 43 of GSP: "An enterprise should have a business place and warehouse suitable for its drug business scope and scale".
3. The "Appendix V" of GSP is verification management, and the requirements include verification of cold storage, refrigerated trucks, refrigerated containers, incubators and automatic temperature and humidity monitoring systems, so as to confirm that relevant facilities, equipment and monitoring systems can meet the specified design standards and requirements, and can operate and use safely and effectively to ensure the quality and safety of refrigerated and frozen drugs during storage and transportation. Facilities and equipment involved in the cold chain system must be verified before they can be put into use; If the facilities and equipment need to be changed, they must be verified again before use. The periodic verification is once a year, which is completed by the Quality Department and the Storage and Transportation Department. After the verification is completed, the deviations should be explained and corrected, and a written verification report should be filed for future reference.
II. Requirements of cold chain for managers
1. Article 28 of GSP stipulates that personnel engaged in the storage and transportation of specially managed drugs and frozen drugs shall receive relevant laws, regulations and professional knowledge training and pass the examination before taking up their posts.
2. The inspectors of the quality department, the receivers, storekeepers, reviewers and distributors of the storage and transportation department shall conduct cold chain knowledge training at least once a year, and then conduct assessment after training. The assessment results and training records shall be kept in the employee training files for future reference.
3. Operating requirements for cold-chain varieties
1. Purchase: To purchase cold-chain varieties, the supplier's quality system should be inspected and its cold-chain management should be understood to confirm its cold-chain management level and quality. Those without cold-chain process management conditions cannot be purchased.
2. Receiving goods: Strict inspection should be carried out on the refrigerated varieties that arrive. First, check whether the means of transport are refrigerated trucks or incubators; The second is to check the arrival temperature, and use temperature measuring gun to detect the temperature in the carriage. The incubator should check the temperature one by one and export the electronic records on the spot; If it meets the requirements, it will be unloaded and directly dragged into the cold storage, and a sign will be put on for inspection. Non-refrigerated transportation, or the arrival temperature does not meet the requirements, shall not receive the goods.
3. Storage: The stacking of drugs in the cold storage should be based on the verification results. No drugs should be stacked at the fan mouth or in the area that is not suitable for loading after verification (no drugs should be stacked within 1 cm of the air outlet of the refrigeration unit in the cold storage or above the air outlet of the cold fan) to ensure the cold air flow in the storage. When drugs are stored in the warehouse, the refrigerator should be turned on 24 hours to ensure that the temperature meets the requirements.
4. acceptance: it will be carried out in the cold storage. after the acceptance, the sign of "products to be inspected" will be replaced by the sign of "qualified products", and at the same time, it will be put into storage in the ERP system.
5. Delivery/recheck: Article 11 of GSP stipulates that "special persons shall be responsible for the packing and loading of refrigerated and frozen drugs and meet the following requirements: (1) The vehicle-mounted refrigerator or incubator shall meet the corresponding temperature requirements before use; (2) Packing and sealing of refrigerated and frozen drugs shall be completed in a refrigerated environment; (3) Before loading, the start-up and running state of the refrigerated vehicle should be checked, and the vehicle can be loaded only after reaching the specified temperature; (4) Transport records should be made at the time of departure, including the means of transport and the time of departure. " Review and packing must be completed in the cold storage. If it is shipped in an incubator, the drugs in the incubator can't directly contact the ice platoon, but can be separated by foam board and waterproof cardboard, not by film.