Wholesale of blood source screening in vitro diagnostic reagents
In order to further standardize the batch issuance management of blood source screening in vitro diagnostic reagents (referred to as in vitro diagnostic reagents) and ensure the smooth implementation of the batch issuance network system management of in vitro diagnostic reagents on May 1, 2011, our hospital held a training course on the batch issuance management system of blood source screening in vitro diagnostic reagents on April 20, 2011. This training course includes two contents: training on the use of the batch issuance network management system of in vitro diagnostic reagents; instructions on the relevant situation of canceling the anti-counterfeiting label of in vitro diagnostic kits. A total of 36 domestic and foreign manufacturers of blood source screening in vitro diagnostic reagents and 88 business and technical personnel participated in the training.
The meeting introduced the arrangement of the Central Inspection Institute to suspend the work of pasting anti-counterfeiting labels on in vitro diagnostic kits, emphasizing that except for the suspension of printing, distribution and pasting anti-counterfeiting labels from May 1, 2011, other procedures for in vitro diagnostic reagent management remain unchanged. The meeting summarized the experience of strengthening government supervision and enhancing the transparency of product quality after the implementation of the batch issuance network management system for vaccines and blood products, and pointed out the problems that should be paid attention to in the use of the batch issuance network management system; After the use of the in vitro diagnostic reagent batch issuance network management system, the Central Inspection Institute will release product-related information every half month, including product name, batch number, batch number, production unit, issuance conclusion, etc. This is one of the five diagnostic reagent supervision measures to improve and standardize after the cancellation of pasting anti-counterfeiting labels.
The meeting also further elaborated on the necessity of stopping the pasting of anti-counterfeiting labels from the current national policies and regulations, the quality status of the five diagnostic reagents, and the responsibilities of the Central Inspection Institute. It requires enterprises to cooperate in the implementation of this work, emphasizing that the next step will be to include in-vitro diagnostic reagents in the national evaluative sampling plan and conduct on-site inspections from time to time. A series of measures will be taken to conduct post-market quality supervision of the product.
The meeting gave a detailed explanation of the use of the diagnostic reagent batch issuance network system, focused on the problems that often occur in the use of the vaccine batch issuance network system, and answered the relevant questions raised by enterprises in detail. Finally, the company representatives carried out on-site operations of the use of the batch issuance network system to ensure the smooth use of the batch issuance network system from May 1.
