What items need to be verified for GSP cold storage verification?

1. The product functions must meet the requirements of the new GSP. The measuring points installed in the cold storage should be classified products, that is, the temperature and humidity sensor should be separated from the transmitter. When installing, the temperature and humidity sensor should be placed in the cold storage, while the transmitter should be installed outside the cold storage. The transmitter has 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 specification requirements: no less than 2 monitoring points below 20㎡, no less than 3 monitoring points at 20-50㎡ and no less than 4 monitoring points at 50- 150㎡; There shall be at least five monitoring points at 15 1-300m2. If it is less than the above requirements, it cannot pass the inspection of the drug supervision department.

3. During installation and debugging, attention should be paid to controlling the temperature range at 2~8℃ and the humidity range at 45~75%. If the temperature exceeds the limit, there should be three kinds of alarms, namely, the local buzzer alarm of the transmitter, the acousto-optic alarm of the control room and the SMS alarm of the administrator.

4. The temperature measuring equipment during on-site verification must be calibrated by the metrological department at or above the provincial level, and relevant certificates shall be issued, otherwise the report will be invalid.

5. The distribution of temperature measuring equipment during on-site verification must conform to the refrigeration principle, and the reasonable verification and test distribution should be carried out in combination with the "refrigeration system design principle". Each verification object adopts one-time synchronous layout to ensure the synchronization and effectiveness of data collected at each measuring point. In the reservoir area to be verified, the unified layout should be comprehensively considered, and the warehouse should be monitored by layers in the height direction, which is divided into three layers: the first layer is 250px from the ground, the second layer is in the middle, and the third layer is 750px from the top of the warehouse. The vertical spacing is not more than 2m, and the horizontal spacing is not more than 5m. 750px from the wall horizontally.

Arrange special purpose and special project points, including air inlet/outlet, doors, windows, lighting, etc., with at least 5 measuring points, and at least 3 measuring points should be arranged at the dead corner of each group of shelves or buildings in the warehouse.