中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2014年
11期
1206-1208
,共3页
林晓明%陈洪忠%冉大强
林曉明%陳洪忠%冉大彊
림효명%진홍충%염대강
药品经营质量管理规范%GSP 认证%重点环节%认证质量
藥品經營質量管理規範%GSP 認證%重點環節%認證質量
약품경영질량관리규범%GSP 인증%중점배절%인증질량
Good Supplying Practice%GSP certification%key aspects%quality of certification
目的：探讨 GSP 现场检查重点问题，为有效提高药品 GSP 认证质量提供参考。方法对新修订药品 GSP 实施以来的检查情况进行梳理，讨论现场认证检查过程中应把握的重点环节，分析检查报告中易出现的问题。结果与结论应进一步统一检查标准，检查报告的撰写应更加规范，以更好地对药品经营企业实施监管，建立良好的药品市场秩序。
目的：探討 GSP 現場檢查重點問題，為有效提高藥品 GSP 認證質量提供參攷。方法對新脩訂藥品 GSP 實施以來的檢查情況進行梳理，討論現場認證檢查過程中應把握的重點環節，分析檢查報告中易齣現的問題。結果與結論應進一步統一檢查標準，檢查報告的撰寫應更加規範，以更好地對藥品經營企業實施鑑管，建立良好的藥品市場秩序。
목적：탐토 GSP 현장검사중점문제，위유효제고약품 GSP 인증질량제공삼고。방법대신수정약품 GSP 실시이래적검사정황진행소리，토론현장인증검사과정중응파악적중점배절，분석검사보고중역출현적문제。결과여결론응진일보통일검사표준，검사보고적찬사응경가규범，이경호지대약품경영기업실시감관，건립량호적약품시장질서。
Objective To discuss the key issues of GSP site inspection,so as to provide a reference for effective improvement of the quality of GSP certification.Methods Based on the elaboration of inspection situation since the implementation of newly revised medicine GSP,the key aspects in GSP-site certification and inspection process that should be grasped were discussed and some common problems in inspection reports were analyzed.Results and Conclusion It is suggested that inspection criteria should be set up and inspection reports be standardized in order to conduct better supervision over pharmaceutical trading enterprises and establish good medicine market orders.
