摘要
Abstract
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.关键词
中药配方颗粒/跨省备案/申报资料/问题/建议Key words
Chinese medicine formula granule/Cross-provincial record/Declaration data/Problems/Suggestions分类
医药卫生
