ABSTRACT
OBJECTIVE：To provide reference for improving the operation efficiency of drug quality sampling and inspection in China . METHODS ：Starting from the application and management situation of inspection standards/methods in provincial inspection institutions ，the problems existing in the application and management of inspection standards/methods in provincial inspection institutions were analyzed ；the inspection standards/methods database of provincial inspection institutions is attempted to build，combining with the relevant experience and practices of FDA. RESULTS & CONCLUSIONS ：The inspection methods involved in drug sampling and inspection could be divided into official standards and non-standard methods. Official standards were the main standards for drug sampling and inspection ，and were mainly used for routine inspection. Such kind of standards could be classified according to the characteristics of compiled ，single-page and later-issued supplementary ；an electronic catalogue should be established for unified management. Non-standard methods were only used for sample preliminary screening ，verification of official inspection results ，quality evaluation and inspection of unknown or suspicious samples in emergency inspection. Its tracking，collection and management mechanisms were not yet complete. It is recommended to draw on the experience of drug sampling and inspection in the United States so as to establish method database hierarchically. For the mature method established in drug supervision system ，an electronic catalog and document content database should be established and the method should be confirmed before use ；for national standards and the recommended methods published by authoritative institutions in other industries，and mature methods published in scientific and technological literature ，the retrieval channels should be listed ，the methods should be verified ，reviewed and approved before use ，and an electronic catalogue should be established and recorded in time after use. The electronic catalogue format of non-standard methods generally include controlled number ，applicable variety name，method name ，inspection items ，etc.
ABSTRACT
Objective:To provide specific suggestions for the reasonable application of various quality sampling inspection methods for Chinese herbal medicines in order to improve the scientificity of sampling inspection plan. Methods:The sampling inspection pro-gram and the overall quality of Chinese herbal medicines in Hubei province from 2014 to 2016 were reviewed and the existing problems were analyzed, finally, suggestions for improvement were proposed for the future work. Results and Conclusion:The current sampling inspection methods have made certain achievements;however, each method still needs optimization. It is suggested that the supervision sampling inspection be standardized to solidify the basis of sampling inspection, special sampling inspection be arranged periodically to target the complicated and recurring quality issues, and evaluation sampling inspection be strengthened for certain varieties to evaluate the overall quality status and discover the risk signals.
ABSTRACT
OBJECTIVE:To evaluate the quality of sampling drugs of Hubei province,and to provide reference for drug enter-prises and supervision department. METHODS:The data obtained by Hubei Institute for Food and Drug Control about provincial drug sampling and testing from 2013 to 2015 were summarized,the overall quality and unqualified items were statistically analyzed according to current standard. RESULTS & CONCLUSIONS:The number of total sampling batches was 7721 and that of the un-qualified batches was 333 (4.3%) during 2013-2015. Most of the unqualified samples came from distribution units (2.8%-9.0%) and medical institutions (5.2% -11.7%). Among all sample types, the herbal medicine has the highest unqualified rate (12.1%-37.4%),with the largest number of unqualified items(content determination,supplement inspection item,property,resid-ual amount of sulfur dioxide,ash content). The quality of pharmaceutical preparations is relatively stable,and the unqualified items correlated with drug types and dosage forms. The current issues of provincial drug sampling and testing are the variety of standard levels,unreasonable sampling resource allocation and the low level of the industry. Supervision department is proposed to readjust drug standard,reasonably plan sampling and testing process and strengthen production source controlling.