Shanxi carries out special inspection on Chinese herbal extracts

On August 30, 2017, Shanxi Provincial Food and Drug Administration issued the implementation plan for special inspection of traditional Chinese medicine extracts in Shanxi Province In order to further strengthen the supervision and management of traditional Chinese medicine extracts and implement the requirements of the notice on strengthening the supervision and management of extracts and extracts in the production of traditional Chinese medicine (sfjyhjj [2014] No 135) and the announcement on implementing the relevant provisions on the supervision and management of traditional Chinese medicine extracts and extracts (2015 No 286), this implementation plan is hereby formulated 1、 Inspection scope: the whole province's traditional Chinese medicine extract manufacturing enterprises and traditional Chinese medicine preparation manufacturing enterprises 2、 Inspection contents (1) key inspection of traditional Chinese medicine extract production enterprises: production record of extract; organization of production in accordance with GMP requirements; existence of OEM production behavior of purchased traditional Chinese medicine extract （2） Key inspection of traditional Chinese medicine manufacturers: the use and filing of extracts; the quality evaluation and supplier audit of extracts; whether the material balance is in the production process; whether there is any illegal use of extracts （3） The key inspection of pharmaceutical manufacturers that share and set up extraction workshops in different places within the group: the review and approval of provincial food and drug administration; the production and quality management of extracts; and the adequacy of quality control measures in the storage, packaging and transportation of extracts （4） Implementation of the filing of traditional Chinese medicine extracts by the Provincial Bureau 3、 Work and schedule (I) self inspection and rectification stage (before the end of August 2017) All municipal bureaus shall inform the relevant enterprises producing and using Chinese herbal extracts in the administrative region to carry out self inspection, conduct comprehensive and in-depth investigation against the inspection contents, timely rectify and record the problems found, complete the self inspection report, and report the self inspection to the Municipal Bureau and Provincial Bureau before August 30, 2017 （2） Special inspection stage (before the end of September 2017) All municipal bureaus shall organize on-site inspection in accordance with the requirements of this plan, investigate and deal with the problems found according to laws and regulations, urge enterprises to produce and use extracts in strict accordance with requirements, and implement the main responsibility of enterprises The Provincial Bureau will organize personnel to supervise and inspect the implementation of special inspections of each Municipal Bureau The Provincial Bureau shall carry out self inspection on the implementation of the filing of Chinese herbal extracts, and carry out extended inspection if necessary （3） Analysis and summary stage (before the end of October 2017) All municipal bureaus summarize the special inspection work, which mainly includes the work of record management and supervision and inspection, main results, existing problems, rectification implementation, daily supervision requirements and relevant suggestions Please submit the special inspection summary to the drug production supervision office of the Provincial Bureau before October 25, 2017 4、 Work requirements (1) raise awareness and strengthen leadership All municipal bureaus should fully understand the importance of continuously strengthening the supervision and management of Chinese herbal extracts, and further strengthen the supervision of the production and use of extracts We should attach great importance to this special inspection, organize personnel to carry out on-site inspection, make supervision and inspection records, and timely enter the supervision information platform （2） Focus on the key points and investigate and deal with them seriously All municipal bureaus shall, in accordance with the key points of this special inspection, concentrate their efforts on supervision and inspection In the special inspection, the problems found in the enterprise shall be supervised to be rectified within a time limit, and the problems found in violation of laws and regulations shall be seriously investigated and dealt with according to law, and the illegal behaviors shall always be kept in a high-pressure situation When finding clues to major cases, they shall report to the Provincial Bureau in a timely manner （3） If there are any problems and suggestions in the special inspection, please contact the Provincial Bureau in time.