Several issues that need attention in the cold storage verification report in the new GSP requirements

Several issues that need attention in the cold storage verification report in the new GSP requirements

The new version of the GSP requires that pharmaceutical business and distribution companies must build a temperature and humidity monitoring system, and form a verification report after scientific testing for inspection by the drug regulatory department. Generally, cool warehouses, room temperature warehouses, medicine equipment warehouses, Chinese medicine decoction pieces warehouses, cold storages, refrigerated trucks, and incubators are all within the scope of inspection. What issues should be paid attention to when submitting the verification report for the cold storage that is the key inspection object?

　　 1. Product functions must meet the requirements of the new version of GSP. The measuring point of the cold storage installation should be a split product, that is, the temperature and humidity sensor is separated from the transmitter. The temperature and humidity sensor is placed in the cold storage during installation, and the transmitter is installed outside the cold storage. The transmitter should have its own LCD temperature and humidity. Display, so you can know the internal temperature and humidity without opening the cold storage door.

2. Arrange the monitoring points according to the requirements of the specification: there should be no less than 2 monitoring points for a single flat warehouse of 20 square meters, no less than 3 monitoring points for 20-50 square meters, and no less than 4 monitoring points for 50-150 square meters; 151 -300㎡ should have no less than 5 monitoring points. If it is less than the above requirements, it cannot pass the inspection of the drug regulatory department.

3. When installing and debugging, pay attention to the temperature range of 2~8℃, and the humidity range of 45~75%. If the limit is exceeded, there should be three local alarms, namely: transmitter buzzer alarm, control room sound and light alarm , Administrator's mobile phone SMS alarm.

　　4. The temperature measurement equipment used in the field verification must be calibrated by the metrology department at or above the provincial level, and relevant certificates must be issued, otherwise the report is invalid.

　　5. The layout of temperature measuring equipment during on-site verification must conform to the principle of refrigeration, and the layout of reasonable verification tests shall be carried out in conjunction with the "refrigeration system design principle". Each verification object adopts a one-time synchronization arrangement to ensure the synchronization and validity of the collected data at each measuring point. The warehouse area to be verified is uniformly distributed, and the warehouse is monitored layer by layer in the height direction. The warehouse is divided into 3 levels: the first level is 10cm from the ground, the second level is in the middle, and the third level is 30cm from the top of the library. The vertical distance is not more than 2 meters, and the horizontal distance is not more than 5 meters. The horizontal plane direction is 30cm away from the wall.

Layout of special purpose and special project points, including at least 5 measuring points for air inlet/outlet, door, window, lighting, etc., and at least 3 measuring points for the wind direction and dead corner of each group of shelves or building blind corners in the warehouse .