Autonomous Region Bureau carries out special inspection on the use of purchased Chinese herbal extracts by pharmaceutical manufacturers

In order to master the use of outsourcing extracts by pharmaceutical manufacturers in our region, prevent and control the quality risk of Chinese patent medicine production, and ensure the quality of Chinese patent medicine production, in the near future, the drug production supervision office of the food and Drug Administration of the autonomous region organized a special inspection on the use of outsourcing Chinese herbal extracts by pharmaceutical manufacturers in the region The special inspection shall be organized and implemented by the drug production supervision office of the autonomous region, and six inspection teams shall be composed of the staff of relevant municipal bureaus The special inspection shall be carried out for 19 drug production enterprises in the region that have been approved by the State Administration for filing before June 1, 2016, focusing on the legality of the purchased Chinese herbal extracts of the production enterprises and the audit and extraction of the suppliers by the enterprises The transportation (storage), use and other key links of the product, and the implementation of GMP in the enterprise were spot checked During the inspection, it was found that most of the enterprises using the purchased extract failed to provide the on-site audit materials for the extract production enterprises; the enterprises generally paid insufficient attention to the impact of the transportation and storage process of the purchased extract on the quality; at the same time, it was found that some problems of the enterprise did not conform to the GMP, and the problems found had been required to be rectified within a time limit and then reported to the Municipal Bureau for reexamination In the next step, the Autonomous Region Bureau will strengthen the supervision, require the Municipal Bureau to strengthen the daily supervision of the outsourcing use of Chinese herbal extracts, strengthen the inspection of key links such as the transportation and storage of the outsourcing Chinese herbal extracts, prevent and control risks, and ensure the quality risk of Chinese patent medicine production.