SFDA specially inspected 7 pharmaceutical manufacturers

Recently, the Municipal Food and drug administration has carried out a one month special inspection on seven pharmaceutical manufacturers using Chinese herbal extracts in the city by three ways: on-site inspection, data review and important data spot check Through inspection, all enterprises are able to produce according to the approved process and prescription, no fake and inferior Chinese herbal medicines, non-medical parts of Chinese herbal medicines and contaminated or extracted Chinese herbal medicines are found to be used for drug production, and quality assessment and audit are conducted for the qualification of suppliers It is understood that the extraction and extraction of traditional Chinese medicine is the premise and material basis to ensure the quality control, safety and effectiveness of traditional Chinese medicine There are 25 varieties and specifications of Chinese herbal extracts used by these 7 pharmaceutical manufacturers, involving 28 Chinese herbal extracts, including 7 Chinese herbal extracts extracted by the enterprises themselves and 21 outsourced extracts For self extracting Chinese herbal extracts, it is important to check whether there are pretreatment facilities and equipment for Chinese herbal medicines that are suitable for the varieties produced; whether there are corresponding pretreatment process procedures for processing and processing Chinese herbal medicines; whether there is extraction capacity that is suitable for the varieties and scale of production; whether they are produced in strict accordance with the approved process and prescription; whether there are Chinese herbal drinks that should be used Whether there are six aspects of the behavior of using fake and inferior Chinese herbal medicines, non-medical parts of Chinese herbal medicines and contaminated or extracted Chinese herbal medicines to produce drugs For the purchased Chinese herbal extracts, we mainly check whether the purchasing channels are legal, whether the quality assessment and supplier audit are conducted for the Chinese herbal extracts manufacturers according to the requirements In addition, the bureau also carried out a comprehensive inspection on the inspection of the seven drug manufacturers, and found that all enterprises were able to carry out the inspection in accordance with the national standards.