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Design temperature and GSP acceptance requirements of Shanghai biological reagent cold storage

Design temperature and GSP acceptance requirements of Shanghai biological reagent cold storage

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In recent years, the development of pharmaceutical industry has been deeply influenced by policies.

For example, in recent years, the new version of GSP and the "two ticket system" for 电竞押注 purchase and sale have all impacted on the existing pattern of pharmaceutical circulation.

In the first half of 2019, Biological reagent cold storage With the frequent occurrence of construction industry policies, supply chain management and logistics operation in the field of pharmaceutical circulation are facing new challenges.

The behavior of 电竞押注 circulation is related to the 电竞押注 safety of the majority of people. The supervision in the field of 电竞押注 circulation has always been the focus of 电竞押注 supervision.

 

Among them, the wholesale enterprise of biological reagent cold storage construction is an important link in the field of 电竞押注 circulation. It is the key to ensure the quality control in the field of 电竞押注 circulation to do a good job in the supervision of the operation quality of 电竞押注 wholesale enterprises.

On April 19, 2007, the former State Food and Drug Administration issued the notice on issues related to the implementation of the measures for the registration and administration of in vitro diagnostic reagents (Trial Implementation) (No. 230 [2007] of the State Food and Drug Administration). The document clearly stipulates the classification of products: the in vitro diagnostic reagents used for blood source screening and the in vitro diagnostic reagents labeled with radionuclides should be used according to the national laws Product management.

 

Therefore, the supervision of biological reagent cold storage construction enterprises is also an important part of 电竞押注 circulation supervision.

In December 2016, the inspection items of the newly revised "guiding principles for on site inspection of good quality management practices for pharmaceutical products" were divided into three parts. The former State Food and 电竞押注 administration included biological reagent business enterprises into the scope of GSP certification for the first time.

 

At the same time, according to the notice of Shanghai food and Drug Administration on the further implementation of "Shanghai food and Drug Administration" No. 379 on the implementation of Shanghai food and Drug Administration [2016] No. 379 on the implementation of Shanghai food and Drug Administration [Shanghai food and Drug Administration] No Pharmaceutical enterprises that have not passed the requirements of GSP will not continue to operate since October 2017.

 

Shanghai 电竞押注 evaluation and verification center has officially launched GSP certification and inspection work for biological reagent cold storage construction enterprises in this city. After two years of efforts, the GSP certification and inspection work of the 电竞押注 diagnostic reagent business enterprises in this city has been basically completed.

  Biological design of Shanghai cold storage

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