Analysis of problems and reasons for cross-provincial record-keeping of traditional Chinese medicine dispensing granule
Objective To study the problems of cross-provincial record-keeping of Chinese medicine formula granule enterprises,and to provide reference for Chinese medicine formula granule enterprises to improve the quality of record-keeping data.Methods The cross-provincial record data submitted by the Pharmaceutical Business Application System of National Medical Products Administration were taken as the research object,the problems found in the record materials are analyzed and summarized by the method of summary and induction.Results There are issues with the completeness of cross provincial registration(Shandong Province)documents,production qualifications,application of national and provincial standards,validity period of registration certificates,and inheritance of registration certificates for traditional Chinese medicine formula granule production enterprises.Conclusion the manufacturers of TCM formula granules need to study the laws,regulations and policies related to TCM formula granules,accurately grasp the requirements of cross-provincial sales records,and timely according to the changes of the national standard of TCM formula granules,to adjust the cross-provincial information submis-sion,effectively carry out the main responsibility of quality assurance of traditional Chinese medicine formula particles,to en-sure the authenticity,integrity and traceability of cross-provincial information.
Chinese medicine formula granuleCross-provincial recordDeclaration dataProblemsSuggestions