Industry News
Anhui Provincial Food and Drug Administration further strengthens the basic drug supervision and sampling and testing work
In order to strengthen the basic drug quality supervision, guarantee the basic drug quality and safety, Anhui Provincial Food and Drug Administration further strengthens the basic drug sampling and testing work.
1.Ensure the full coverage testing for the production. Each city should carry out supervision and sampling and testing work according to the drugs production enterprise and the basic drug approval number listed in Anhui province "drug production enterprises basic drug testing coverage statistics". Of which, the municipal bureau is responsible for sampling, drug inspection institutions of the local area for sampling and testing work, the sampling work fits into the municipal daily inspection category; for the not enough sampling varieties in the basic drug special testing, those selected are sent to special inspection institute to determine the inspection, and the sampling quantity is calculated into basic drugs special sampling. If the basic drugs produced by the enterprises are in stock, just take from its inventory sampling; for those out on sale, according to where product sales may go, begin tracking sampling (within the scope of the province circulation, the municipal bureau the production enterprises belong to can entrust the local bureau where the products go to carry out supervision and sampling and send them to the municipal institute where the production enterprises are located for testing), and for those samples hard to be found in the province drug market, just take them from production enterprise sample extraction.
2.Begin as a whole by compensating sampling. As a result of the by-election supplement testing varieties for the market to use less or expensive medicines, just uniformly take a sample retained mode for the portion of the sample, namely, for the extraction of three times the amount of the drug samples, the double amount is sent to inspection institute for testing, another two times the amount are trapped in the entity under sampling. For those tested in line with the drug standard, inspection institution shall timely notify the sampling unit and the sampling unit shall be unsealed; for those found not to meet the drug inspection standard, the inspection institution shall timely inform the sampling unit, and the sampling unit shall send another two samples to the inspection institution within 3 days from the date of receiving the information.
3.Non-production shall be reported in written form. For those essential drugs not produced by the producing enterprises by the end of October, the local municipal FDA urged the enterprises to submit no production certificate.
4.Sampling information shall be timely submitted. Strictly according to the annual inspection plan requirements, send on schedule the basic drug testing information and delivery testing report; the Provincial FDA will make known monthly each city's work progressing in basic drug sampling and testing.